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ADVANCED MATERIALS & PROCESSES/JANUARY 2008 63

Materials and Processesfor Medical Devices

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On the CoverThe Instron Advanced Video Exten-someter (AVE) is a high performance,noncontact extensometer with meas-urement performance that meets orexceeds that of traditional contactextensometers. The unit contains nomoving mechanical parts and there-fore is not susceptible to effects frommechanical inertia or wear. A highresolution digital camera and ad-vanced real-time image processingmake precise axial and transverse(optional) strain measurements onmaterial test specimens. Image cour-tesy Instron.

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Arecent study by the 3i Group suggests that nanostructured personal health diagnostics, arti-ficial bones, artificial tissues, and artificial organs will be the most promising developmentsfor improved medical devices over the coming decade. Currently more than 150 small,medium, and large companies are pursuing nanomaterial-based medical devices for treat-

ment of orthopedic, ophthalmic, cardiology, urology, obesity, diabetes, and cosmetic conditions. These companies are seeking to develop or maintain high rates of profitability through development

of revolutionary products (new devices) and evolutionary products (improved device functionalityprovided by nanomaterials). Several factors will influence nanomaterial-based medical device develop-ment over the coming years:

• Appropriate nanotechnology-based medical devices. Laser-based procedures were developed in the1970s and 1980s for treatment of nearly every human tissue; however, only laser-based dermatologyand ophthalmology procedures remain in common practice today.

• Pricing of nanomaterial-based medical devices. For example, a conventional uncoated metal stentis sold for $1000 and a drug-eluting stent is sold for $3200, although the manufacturing costs for these de-

vices differ by only $225. As in the case of drug-eluting stents, the oper-ating margins and stock values for medical device companies will rise andfall based on the progress of their nanomaterial-based medical devices.

• Food and Drug Administration regulation of nanomaterials. Recentsafety problems in Germany with Magic Nano household cleaner have re-sulted in increased scrutiny of all consumer nanomaterials.

• Allocation of funding needed to take a nanomaterial innovation fromconcept to market. It is estimated that a new Class III medical device re-quires a minimum of ten years and twenty million dollars to gain approval.

• Interaction among regulatory consultants, physicians, engineers, andbiologists. Large companies often rely on broad technical expertise acrossthe materials science, engineering, biological, and medical disciplines tointernally develop novel devices.

• Competition from Japan and Europe in the development of nano-material-based medical devices. Private companies in these regions bearlower operating costs and receive significant government incentives forapplied research.

• Consumer awareness. Advertising campaigns for medications are nowcommon, and those for medical devices may become more prevalent inthe future.

• Complex reimbursement and payment issues. Health insurers, em-ployers, and public health programs are placing stringent protocols on theadoption of medical devices in an effort to control costs.

In spite of all of these challenges, there is no doubt that recent develop-ments in nanomaterials research will have a profound influence on ma-terial suppliers, medical device producers, and health care providers overthe coming years.

Roger Narayan, M.D., Ph.D.Joint Department of Biomedical Engineering, University of North Carolina and North Carolina State UniversityDepartment of Materials Science and Engineering, North Carolina State University

OBSERVATIONS

The crucial role of nanomaterials innovation

64 ADVANCED MATERIALS & PROCESSES/JANUARY 2008

2

Materials for Medical Devices and Processes 2008:

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Just imagine what a photomicro-graph in the world class ASMMaterials for Medical Devices data-base will have to say. As a partner indeveloping this database, Buehlerprovided high quality cross sectionimages of materials in various stagesof processing including final products.

After a recent demonstration, mem-bers of the National Academies'Roundtable on Biomedical Engineer-ing Materials and Applicationsshowed strong interest and enthusi-asm for the database. "The BEMABoard was very impressed, " saidMichael N. Helmus, Ph.D., chairmanof the ASM Medical DevicesDatabase Committee.

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CoCrMo beads on CoCrMo cast substrate. Etchant5:1 HCl to H2O2 (3% conc.), Scale bar: 50�m.

CoCrMo structure at the joint between cast portionand wire. Etchant Lucas’ Reagent.

316SS Etched with 10% Sodium Metabisulfiteviewed in brightfield.

Vitamin E added to UHMWPE provides oxidation stabilityTwo new grades of ultrahigh molecular weight polyeth-

ylene (UHMWPE) containing vitamin E (alpha-tocopherol)have been announed by Ticona, Germany. The addition of abiocompatible antioxidant provides these new grades witheffective oxidation stability. The aim is to further extend thelifetime of orthopedic implants.

Stabilization with vitamin E is intended to reduce suscepti-bility to oxidation during sterili-zation. GUR polymers meet the requirements of standard ASTM F648 pub-lished by the American Society for Testing and Materials and ISO standard5834-1/-2 for starting materials and semi-finished products.

For more information: Henning Kull, Ticona, Kelsterbach, Germany; tel: 49(0) 6107 772 17 97; fax: 49 (0) 6107 772 72 31; [email protected]; www.ticona.com.Ticona North American Headquarters, 8040 Dixie Highway, Florence, KY 41042;tel: 800/833-4882.

Layers yield stronger, more successful bone implantsA new method for layering two kinds of

biomaterials into one strong, yet porousunit that may lead to improved reconstruc-tion or repair of bones is under develop-ment by researchers from the AmericanDental Association Foundation (ADAF)and the National Institute of Standards andTechnology (NIST).

First, a macroporous calcium phosphatecement (CPC) paste is placed into the areaneeding reconstruction or repair. Then, afiber-reinforced CPC paste is layered ontothe first to support the new implant. Afternew bone has grown into the macroporouslayer and increased its strength, the ab-sorbable fibers in the strong layer dissolve and create additional macroporouschannels that promote even more bone ingrowth. This method mimics the nat-ural bone structure in which a strong layer of cortical bone covers andstrengthens a weaker macroporous layer of spongy bone.

For more information: Elena Burguera, National Institute of Standards andTechnology, 100 Bureau Drive, Gaithersburg, MD 20899-8546; tel: 301/975-5296; [email protected]; www.nist.gov. Contact: Michael E. Newman,tel: 301/975-3025; [email protected].

Image contrast grade of polymer provides tailored opacityInvibio has introduced an image contrast grade of Peek-Optima polymer.

The new image contrast grade offers the superior mechanical, physical, andbiocompatible properties of unfilled polymer with the added advantage of tai-lored opacity, enabling medical device manufacturers to develop implants thatcan be observed more clearly with X-ray and CT imaging while remainingcompatible with MRI.

Unlike metals, the image-contrast grade provides medical device manufac-turers the flexibility to tailor the radiographic, CT, and MRI visibility of an im-plant to suit a particular application. Now it is possible for device manufac-turers to achieve an appropriate balance of implant and tissue visualizationwithout image artifacts or scatter.

For more information: Invibio Inc., 300 Conshohocken State Road, West Con-shohocken, PA 19428; tel: 866/468-4246 or 484/342 6004; www.invibio.com.


Dynamet, a subsidiary of Carpenter Technology, Washington, Pa., has

developed a new line of small-diameter titanium machining bar that

provides very tight dimensional tolerances and exceptional size

consistency and straightness. CalledUltraBar, it offers improved quality

and higher productivity for small, intricate, precision parts made on

Swiss-type automatic screw machines. It is suitable for posts,

abutments, and healing caps indental implants. Thedra Wagner,

Dynamet, 195 Museum Road, Washington, PA 15301; tel: 800/237-

9655; fax: 724/229-4195;[email protected];

www.dynamet.com.

Nanofibrous scaffolds for bonegrafting of large gaps in bone have

reportedly been developed by Prof.Xiaojun Yu, Stevens Institute of

Technology, Hoboken, N.J. He hasproposed a way to incorporate

nanofibers onto biodegradable polymeric three-dimensional

scaffolds that have optimal porositydue to open geometrics and large

surface area. This porosity permitsthe necessary nutrient transport andcell penetration into the scaffold for

successful repair of large bone defects. Xiaojun Yu, Stevens Instituteof Technology, Hoboken, NJ 07030-

5991; tel: 201/216-5256;[email protected]; www.stevens.edu.

Wright Medical Group Inc. has released Pro-Dense Injectable

Regenerative Graft, a bone graftsubstitute that is a composite of

calcium phosphate and sulfate. Itfeatures a unique, tri-phasic

resorption profile providing the biologic environment to allow the

body to quickly and reliably regenerate dense new bone.

Extensive animal testing found thatnew bone was of greater density and

greater compressive strength at 13weeks than the new bone

regenerated by autograft, andformed new bone at a faster rate than

autograft. John K. Bakewell, Wright Medical Group Inc., Arlington, TN;tel: 901/867-4527; www.wmt.com.

High-magnification scanning electron microscopy shows (center of micrograph)the leg of an osteoblast (bone precursor),called a cytoplasmic extension, attachingto nano-sized hydroxyapatite crystals,similar to those in natural bone.

MATERIALS4

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Carbon nanotubes on anodizedtitanium helps bones attach

Carbon nanotubes on anodizedtitanium significantly improve theattachment of titanium implantsto bone, report researchers atBrown University, Providence, R.I.Thomas Webster and the teamtreated titanium and applied anelectrical current, creating a pittedcoating in the surface of the tita-nium. The pits were then packedwith a cobalt catalyst, and the ti-tanium samples were run througha chemical process that involved heating them to 700°C (1290°F).The process caused carbon nanotubes to grow from each pit.

Researchers then placed human osteoblasts onto the nanotube-covered titanium as well as onto samples of plain and anodized ti-tanium. All were placed in an incubator. After three weeks, the teamfound that the bone cells grew twice as fast on the titanium coveredwith nanotubes. Cells interacting with the nanotubes also made sig-nificantly more calcium.

For more information: Thomas Webster, Brown University, Prov-idence, RI 02912; tel: 401/863-2318; [email protected];www.brown.edu.

MATERIALS 5

A titanium surface covered by carbon nanotubes could lead to faster, better growthof implanted bone-growing cells and an improved success rate for orthopaedic surgery. The carbon nanotubes could even self-report, keeping doctors informedabout the healing process. Sirinrath Sirivisoot/Brown

Nanowire coating on the surface of biocompatible titanium is under development byresearchers at the University of Arkansas,Fayetteville. An alkali and heat are applied to a titanium device, causing the growth of titaniumoxide-based ceramic nanowires that coat the surface. The length, the height, the pore openings, and the pore volumes can all be controlled. The material can easily be sterilizedwith ethanol or ultraviolet light and water. Prof. Z. Ryan Tian, University of Arkansas, Fayetteville, AR 72701; tel: 479/575-2653;[email protected]; www.uark.edu.

Fiber for orthopedic sutures surpasses polyester in healing

DSM Dyneema announces that Dyneema Purity has beenshown to promote better tissue formation than traditionalpolyester in orthopedic suture applications. In independenttesting by NAMSABiomatech Lab, braids made of DyneemaPurity reportedly exhibited enhanced fibro-connective tissueformation as well as reduced irritation and lower inflamma-tion than polyester. Coupled with exceptional mechanicalproperties, these results make this ultrahigh molecular weightpolyethylene an excellent alternative to polyester.

Inherent characteristics include small filament diameter,chemical inertness, and an extremely smooth surface. It alsooffers high stiffness, fatigue and abrasion resistance, and asoft feel. It has been certified according to ISO standards forgenotoxicity, cytotoxicity, sensitization, hemocompatibilityand mutagenicity.

For more information: Nathali Donatz, EMG DSMDyneema, Geleen, The Netherlands; tel: 31 164 317 017; fax:31 164 317 039; [email protected]; www.implant-morestrength.com

Stereolithography resins resisthigh heat, have low shrinkage

NanoTool is a reinforced composite material with a heatdeflection temperature >500°F (after thermal post-cure) anda flexural modulus value of 10,000 MPa. The resin’s verylow linear shrinkage (<0.001 inch) allows for extremely ac-

curate and highly detailed parts. Infact, a 20 to 30% metal-to-resin volumeratio with NanoTool is enough to pro-duce parts with a tensile strength similar to a variety of alloys including magne-sium, aluminum, and zinc, but in much less time. In addition, as little as 0.002-inch-thick nickel plating allows the SL parts to be used for electromagnetic interferenceshielding.

For more information: DSM Somos, 1122 St. Charles Street, Elgin, IL 60120; tel: 847/697-0400; www.dsmsomos.com.

Electrostatic spray applies calcium phosphate to implantsA new method for depositing ceramic coatings onto implants by an electrostatic

spray deposition (ESD) technique is under development at the Radboud Univer-sity Nijmegen in The Netherlands. According to Prof. Leeuwenburgh, “ESD cre-ates an electrospray of finely dispersed micro-sized droplets. The droplets have acharge that attracts them to the implant material. With ESD, very thin layers of justa few micrometers can be applied to the substrate surface. The method is simpleand cheap, and it allows variation of the surface coating structure, in terms of prop-erties such as porosity and texture.”

Calcium phosphate ceramics, having a similar inorganic composition to boneand teeth, are used for this purpose. Bioactive coatings of ceramic calcium phos-phate improve the growth of bone tissue onto dental and orthopedic implants.

ESD could prove particularly useful as a means of applying ceramic coatingsalong with biological agents such as growth factors or drugs. These agents cannotbe sprayed by a high-temperature process such as plasma spraying.

For more information: Dr. Sander Leeuwenburgh, Radboud University NijmegenMedical Center, The Netherlands; tel: 31 (0)24 – 3614461; fax: 31 (0)24 – 3614657;[email protected]; www.biomaterials-umcn.nl

MATERIALS


6

Biopolymers designed for implantable medical devices

Solvay Advanced Polymers announcesthe launch of its Solviva family of bioma-terials for implantable medical devices.

• Zeniva PEEK (polyetheretherketone)is one of the most chemically resistantplastics available, exhibiting high strengthand stiffness along with excellent tough-ness and fatigue resistance

• Proniva SRPI (self-reinforced poly-phenylene) is the stiffest and strongest unreinforced thermoplastic available, offering exceptional chemical resistanceand hardness. • Veriva PPSU (polyphenylsulfone) of-

fers unsurpassed toughness combinedwith transparency and excellent chemicalresistance.• Eviva PSU (polysulfone) has practical

toughness in a strong, transparent polymer. Solvay is currently in active product trials

for its line of Solviva biomaterials withseveral medical device manufacturers.

For more information: Mark Wheeler,Solvay Advanced Polymers, 4500 McGinnisFerry Road, Alpharetta, GA 30005-3914;tel: 770/772-8849; [email protected]; www.solvivabiomaterials.com; www.solvayadvancedpolymers.com.

Netherlands Organization forScientific Research reports

that nanoparticles consisting ofpolyethylene glycol (PEG)

chains that are attached tolactic acid derivatives of

polymethacrylamides are underdevelopment as drug delivery

vehicles. These new chainscombine biodegradability and

heat sensitivity. By simplyheating up an aqueous

polymer solution, compactspherical nanoparticles smaller

than 100 nanometers are spontaneously formed. The

properties and life span of so-called “stabilized micelles”

can be completely controlled bychanging the components. The

spherical structures can encapsulate various fat-soluble

medicines, which makes iteasier to target tumor tissue.

The breakdown period can be adjusted

by using different componentsfor the nanostructures. Dr. Cristianne Rijcken,

Utrecht University, NetherlandsOrganization for Scientific

Research, The Netherlands;[email protected].


TESTING/R&D8

Miniature magnetic sensor enables noninvasive monitoringA tiny sensor that can detect magnetic field changes as small as 70

femtoteslas—equivalent to the brain waves of a person daydreaming—has been demonstrated at the National Institute of Standards and Tech-nology (NIST), Boulder, Colo. The sensor could be battery-operatedand could reduce the costs of noninvasive biomagnetic measurementssuch as fetal heart monitoring.

The NIST prototype consists of a single low-power (milliwatt) infraredlaser and a rice-grain-sized container with dimensions of 3 by 2 by 1 mil-limeter. The container holds about 100 billion rubidium atoms in gas form.As the laser beam passes through the atomic vapor, scientists measurethe transmitted optical power while varying the strength of a magnetic

field applied perpendicularto the beam. The stronger themagnetic field, the morelight is absorbed.

The NIST group and col-laborators have used a mod-ified version of the originalsensor to detect magneticsignals from a mouse heart.The new sensor is already powerful enough for fetal heart mon-itoring; with further work, the sensitivity can likely be improvedto a level in the 10 femtotesla range, sufficient for additionalapplications such as measuring brain activity.

For more information: John Kitching, National Institute ofStandards and Technology, Boulder, CO 80305-3328; tel: 303/497-4083; [email protected]; www.nist.gov/public_affairs/releases/magnetomer.html.

ISU receives $842,000 to develop ‘smart’ prosthetic handA “smart” prosthetic hand in which nerve signals will fully

simulate natural grasping, lifting, and twisting hand motionsis under development at Idaho State University, Pocatello. TheUnited States Army Medical Research and Material Commandof the Department of Defense funded the first phase of thisthree-phase project in the summer of 2007, providing an$842,000 grant to ISU for the proposal titled “Smart ProstheticHand Technology Phase I” under the project “Combat Casu-alty Research Program, Telemedicine and Advanced TechnologyProgram – Biotechnology.”

ISU researchers will use skin sensors for “electromyographic”(EMG) signal extraction, recording the electrical activity inskeletal muscle. The scientists will then try to determine whichEMG signals correspond to intended hand motions. Next, theywill try to develop an “intelligent” control for prosthetics witha variety of sophisticated computing techniques, including“neural networks, fuzzy logic, genetic algorithms, and evolu-tionary computing.” After developing a robotic hand, the groupwill test its sensing and transmission systems.

ISU researchers will explore how to create artificial hands andimplants that can be made of materials that will cause fewer in-flammatory reactions.

For more information: Prof. D. Subbaram Naidu, Dept. of Electrical Engineering, Idaho State University, 921 South 8thAvenue, Pocatello, ID 83209; [email protected]; www.isu.edu.

Robot tests foot prosthesisin three dimensions

Athree-dimensional robot test rig that is capableof emulating a variety of different leg movementshas been developed at the Fraunhofer Institute,Germany. Thanks to this robot, it is now possibleto test various components and materials underrealistic conditions for the first time. The robot isable to exert three-dimensional forces, unlike con-ventional testing devices, and can turn, push,or pull in any direction.

“Thanks to bio-mechanical analyses, we under-stand the rolling movements of the foot,” explainsAndreas Reindl. For example, the robot can exerta downward pressure while at the same timepulling forward.

A set of pressure-measuring plates integratedin the treadmill can determine how much loadpressure the shoe’s cushioning material can with-stand. Video recordings and optical recognitionsystems also help to establish which material isbest to ensure that the foot prosthesis is flexibleenough to roll properly, but also firm enough toprovide sufficient stability.

For more information: Andreas Reindl, Fraun-hofer-Gesellschaft, Germany; tel: 49 711 9703642;[email protected]; www.fraunhofer.de.

Vascular stent radial stiffnessand strength are to be evaluated ina proposed new standard fromASTM International CommitteeF04 on Medical and Surgical Materials and Devices. The proposed standard, WK15227, TestMethods for Radial Stiffness andStrength of Balloon ExpandableStents, is under the jurisdiction ofSubcommittee F04.30 on Cardiovascular Standards. KennethJ. Cavanaugh, U.S. Food and DrugAdministration, Rockville, MD20857; tel: 240/276-4141; [email protected]. For Committee F04 membership ormeeting information, contact DanielSchultz, Technical Committee Operations, ASTM International,West Conshohocken, PA 19428; tel:610/832-9716; [email protected].

DVD shows how rapid prototyping makes medical devices fasterThe Society of Manufacturing Engineers announces the release of “Medical Applications of Rapid Pro-

totyping,” its latest DVD that provides an insider’s look at the life-enhancing applications of this tech-nology. Part of SME’s Manufacturing Insights Video Series, the program shows how rapid technologies arebeing used to re-construct anatomy and build parts.

The DVD takes you inside Biomet in Warsaw, Indiana, where engineers demonstrate how CT andMRI scans are converted into rapid prototype models for the purpose of creating custom implants that arespecifically matched to a patient’s own anatomical data. Direct Dimensions in Baltimore, Maryland, showsviewers how 3D scanning technology and rapid prototyping produce aesthetic prosthetics. The videocloses with a visit to the Medical Uni-versity of South Carolina, where ad-ditive fabrication with living cellsand advanced biomaterials producespioneering innovations in tissue engineering.

For more information: Society ofManufacturing Engineers, Dearborn,MI 48121; tel: 313/425-3000; www.sme.org/store.

EU project to developcomposites for implants

Newbone is a European Unionproject whose goal is to find replace-ment materials that enable bone tissueto be regenerated, say researchers atthe University College of Borås,Sweden. The team comprises re-searchers from nine countries.

They are collaborating on researchinto the properties of polymer com-posites that have a better capacity toadapt to the skeleton than currentstainless steel and titanium implants,thereby eliminating risky re-opera-tions. The aim of Newbone is to findreplacement materials that allow thebone’s tissue to be regenerated.

“We’re working with a variant ofpolymers and fiberglass compositesthat have properties compatible withthe bones of the skeleton,” explainsProf. Mikael Skrifvars. This meansthat the mechanical properties of theimplant will be the same as those ofthe bone, and that the implant willfunction well together with theskeleton. When their surface hasbeen treated with bioactive glass,these implants can grow togetherwith bone tissue.

For more information: MikaelSkrifvars, University College ofBorås, Sweden; [email protected]; cell phone: +46 (0)708 196146.


TESTING/R&D 9


DEVICESArtificial cornea saves eyesight

An artificial cornea that is to be clinically tested in early 2008 hasbeen developed in the EU-funded CORNEAproject, by research sci-entists at the Fraunhofer Institute for Applied Polymer Research IAPin Potsdam, and the Department of Ophthalmology at the Univer-sity Hospital of Regensburg.

“Our artificial corneas are based on a commercially availablepolymer which absorbs no water and allows no cells to grow on it,”says IAP project manager Dr. Joachim Storsberg. “Once our partner Dr. Schmidt Intraokularlinsen GmbHhas suitably shaped the polymers, we selectively coat the implants: We lay masks on them and apply aspecial protein to the edge of the cornea, which the cells of the natural cornea can latch onto. In this way,the cornea implant can firmly connect with the natural part of the cornea, while the center remains free ofcells and therefore clear.” The optical front part of the implant is coated with a hydrophilic polymer, so

that it is constantly moistened with tear fluid.For more information: Joachim Storsberg, Fraunhofer Institute,

Potsdam, Germany; tel: 49 331 568-1321; [email protected]; http://www.fraunhofer.de/fhg/EN/bigimg/2007/rn10fo3g.jsp.

DePuy Orthopaedics launches new hip bearing systemDePuy Orthopaedics Inc. has announced a new option for restoring

hip mobility in patients who require total hip replacement: the Pin-nacle Acetabular Cup System AltrX hip bearing, a polyethylenebearing liner. The AltrX polyethylene bearing is used with DePuy’sexclusive Pinnacle Acetabular Cup System, the only product avail-able that provides surgeons with the option of choosing a polyeth-ylene or metal insert with the same outer titanium cup that replacesthe socket of the natural hip.

In laboratory simulations, AltrX polyethylene liners achieved a 92%wear reduction over conventional polyethylene liners, while main-taining excellent mechanical integrity and oxidative resistance. Aunique AltraLink material enhancement process enables the linersto achieve excellent mechanical toughness and oxidative resistance,which helps provide long-term durability of the implant.

For more information: DePuy Orthopedics Inc., a Johnson & JohnsonCo., 700 Orthopaedic Drive, Warsaw, IN 46581; tel: 800/366-8143;www.depuy.com.

Plating systems expand elbow management Small Bone Innovations Inc. (SBi), announces the launch of the R-

Head Lateral Radial Head Implant System. To further augment itsElbow Management System, the company has also launched the R-Head Plating System for internal fixation of proximal radius fractures.

The R-Head Lateral Implant is a side-loading radial head prosthesisthat allows for a minimally invasive approach and exposure in ra-dial head replacement surgery. The head and stem of the implant con-nect by the means of a dovetail locking mechanism that does notrequire a set screw, saving time in the operating room.

The stem of the R-Head Lateral implant is plasma-coated withtitanium for immediate stability in the canal and optimum osteo-integrating properties. As with SBi’s existing implants, the stemhas a 12-degree curve to match the anatomy of the radius. This stemis available with a 2 mm standard collar or a 6 mm extended collar.

For more information: Anthony G. Viscogliosi, Small Bone Innova-tions, 1380 S. Pennsylvania Avenue, Morrisville, PA19067; tel: 215/337-6390; http://www.totalsmallbone.com.

10

Biodegradable plates and screws that canstabilize the vertebrae during cervical spinal fusion procedures have been announced by

Inion, Weston, Fla. The CE Mark from theBritish Standards Institution (BSI) has been received for the Inion S-1 Anterior Cervical

Fusion System enhanced with a radiographicmarker. This advance is designed to facilitate

the post-operative evaluation of the site of surgery with X-rays, by allowing the surgeon

both to confirm the accurate positioning of implants and to visualize and assess the

healing progress. Chris Lee, Chief ExecutiveOfficer, Inion Oy, 2800 Glades Circle Suite 138,Weston, Florida, 33327; tel: +44 1279 874 222;

U.S. tel: 954/659-9224; www.inion.com.

An implantable miniature telescope is underdevelopment for end-stage age-related

macular degeneration by VisionCare Ophthalmic Technologies Inc., Saratoga,Calif. Although the device has not yet been

approved by the Food and Drug Administration, physicians have described arecommended surgical technique to ensureproper product placement while minimizing

damage to the eye. The telescope is 4 mm longand contains two wide-angle glass

microlenses. VisionCare Ophthalmic Technologies Inc., 14395 Saratoga Ave, Ste

150, Saratoga, CA 95070; tel: 408/872-9393;fax: 408/872-9395; www.visioncareinc.net.

A Nitinol spine implant that provides uniformcompression while the alloy’s structure

transforms into a state approximately 20%stronger than 316L stainless steel has been

developed by BioMedical Enterprises Inc., SanAntonio, Texas. Called OSSpine, the U.S. FDA

has given 510(k) marketing clearance for anterior fixation of the cervical spine. Made of

Nitinol, the OSSpine implant is inserted while inits malleable state at room temperature. BME’s

patent-pending OSSforce Implant Controllerenables the implant to be safely heated to

activate its shape change and impart compression forces across the fusion site. Bio-Medical Enterprises Inc., Texas Research Park,14785 Omicron Dr., Suite 205 , San Antonio, TX

78245; tel: 210/677-0354; http://www.bme-tx.com.

DEVICES 11

Implantable contact lens corrects nearsightedness The U.S. Food and Drug Administration has approved the tiny Verisyse lens, made by Netherlands-

based Ophtec BV and its U.S. affiliate, for people with “healthy eyes” and “stable vision.” The implant is smaller than a contact lens and similar to those for treating cataracts, but it does not re-

place the eye’s natural lens. It is inserted through a small incision, and is centered over the pupil betweenthe cornea and iris. “Unlike laser surgery, implantation . . . involves no removal of tissue, and the lens canbe easily removed at any time in the future,” says Rick McCarley, president and chief executive officer ofOphtec’s U.S. unit.

The agency says Ophtec must study the device for five more years tomonitor eye problems, including cataract development and detachmentof the retina. Ophtec’s three-year clinical trial of patients with moderateto severe nearsightedness found vision improved to 20/40 or better in 92%of those studied, while 44% had 20/20 vision or better.

Ophtec’s U.S. affiliate, Advanced Medical Optics, a medical devicemaker based in Santa Ana, California, will distribute the device in theUnited States. The lens is already marketed under the name Artisan inother countries.

For more information: Rick McCarley, Advanced Medical Optics, 1700E. St. Andrew Place, P.O. Box 25162, Santa Ana, CA92799-5162; tel: 714/247-8200; www.amo-inc.com.

MRI enables custom-fit total knee replacementPatients with degenerative knee conditions can now benefit from custom-

fit knee replacements that are tailored to an individual’s unique body me-chanics, size, and gender variations, says Dr. Mitchell Sheinkop, orthopedicsurgeon at the Neurologic and Orthopedic Institute of Chicago. Developedby OtisMed Corp., this custom-fit approach enables surgeons to preservemore bone and ligaments, allowing for better implant fit and alignment.

The implant is made in four steps. Prior to surgery, an MRI takes veryprecise measurements of the knee. Then, proprietary computer softwarecreates a 3-D image, and virtually corrects the deformity to return the knee to its pre-arthritic state. Third,a computerized 3-D image of the implant is Shape-Matched to the anatomically correct virtual knee model.This helps determine the correct implant size and placement, based on normal knee anatomy. Last, spe-

cial cutting guides are created for the surgeon. These patient-specific cut-ting guides indicate exactly where to make bone cuts so that the knee re-placement is customized for the individual.

For more information: Mitchell Sheinkop, Neurologic & Orthopedic In-stitute of Chicago, Chicago, IL 60640; tel: 773/250-0000; http://www.neuro-ortho.org. OtisMed Corp., 26250 Eden Landing Road, Hayward, CA 94545;tel: 888/684-7633; www.otismed.com.

Device technologies improve minimally invasive surgeryCreganna Medical Devices, Galway, Ireland, has developed three new

innovations for minimally invasive surgery: PoleVault, MicroFlex, and Fu-sion Technology.

The PoleVault hypotube improves kink resistance in stent placementcatheters. A critical component of minimally-invasive catheters, used inconjunction with balloons and stents to open up clogged cardiac arteries,the PoleVault hypotube has 40% more kink resistance than other hypo-tubes. MicroFlex is a micro tube for small vasculature applications such asthe neurovascular system.

Fusion Technology is a breakthrough solution for Nitinol to stainless steeltube welding via patented technology.

For more information: Paul Gratiano, Creganna Medical Devices, 450Donald Lynch Boulevard, Marlborough, MA 01752; tel: 603/886-5116;508/658-7146; [email protected]; www.creganna.com.

Medtronic has received 510(k) marketingclearance from the FDA for the CompleteSE (self-expanding) Biliary StentSystem. The device is indicated for thetreatment of cancerous tumors in the bileduct that can compromise digestion byrestricting the flow of digestive fluids. U.S.commercial sales of the new biliary stentwill begin immediately in a wide sizerange, with diameters of 4 to 10 mm andlengths of 20 to150 mm.www.medtronic.com

The Coherex FlatStent PFO ClosureSystem has been implanted for the firsttime in humans in Frankfurt, Germany.The surgeries mark the launch of a European clinical study of the device,made by Coherex Medical Inc., Salt LakeCity, Utah. If all goes well, the device thenwill begin the long FDA approval processin the United States as well. RichardLinder, Coherex Medical Inc., 3598 W.1820 South, Salt Lake City, UT 84104; tel:801/433-9900; www.coherex.com.

A heart pacemaker thatcould be powered by the

beating heart rather than abattery has reportedly beendesigned by David Tran and

colleagues at Stanford University, California. Theteam has come up with anumber of designs that

generate power by virtue ofbeing attached to the

outside of the heart. Thiscauses, for example, a

magnet to move through acoil, or a piezoelectric

element to move in a waythat generates current.

The team says this couldmake implantable devices

self-powering, or at thevery least, increase the

periods betweenreplacements. David Tran,

Stanford University, Stanford, CA 94305; tel: 650/723-0987; www.stanford.edu.



Edwards Lifesciences partners with U. of California at Irvine UC Irvine’s Henry Samueli School of Engineering has received a $5 million gift from Edwards Life-

sciences Corp. to establish a center focused on researching and developing the next generation of cardiovascular devices. The Edwards Lifesciences Center for Advanced Cardiovascular Technology willpromote interaction and collaboration among students, faculty members, and experts by incorporatingboth undergraduate and graduate programs related to heart and vascular diseases. The programs will bedirected by UCI’s Department of Biomedical Engineering, and will involve a variety of other disci-

plines, including students from the Integrated Nanosystems Research Facility,the California Institute for Telecommunications and Information Technology,the Donald Bren School of Information and Computer Sciences, the BeckmanLaser Institute, and UCI’s Schools of Medicine, Physical Sciences, and Bio-logical Sciences.

For more information: Edwards Lifesciences Corp., One Edwards Way, Irvine,CA 92614; tel: 949/250-2500; www.edwards.com.

Drug-eluting polymer receives CE approval to coat stentsMedtronic announces that it has received CE Mark approval for the commercial

sale of the Endeavor Resolute Drug-Eluting Coronary Stent in Europe, and plansto launch the product earlier than originally projected. Endeavor Resolute iscoated with a proprietary new biocompatible polymer called BioLinx, which isdesigned to confer the same biocompatibility as the Endeavor stent’s phospho-rylcholine polymer, while extending the duration of drug exposure in the vessel.

The BioLinx polymer features a unique blend of hydrophilic and hydrophobicelements for optimal performance. Extensive preclinical studies have establishedthe biocompatibility and drug delivery capabilities of the BioLinx polymer.

For more information: Joe McGrath, Medtronic Inc., 710 Medtronic Parkway,Minneapolis, MN 55432-5604; tel: 707/591-7367; www.medtronic.com.

Polymer Technology Group spins out life sciences incubatorPolymer Technology Group (PTG) has spun off a life sciences incubator, Emer-

gence LLC. It will have access to PTG’s world-class staff and state-of-the-art facilities for synthesis, characterization, processing, regulatory approval, andmanufacturing resources in the development of novel medical devices. Initially,Emergence will conduct its business within PTG’s 53,000-square-feet facilities inthe Temescal Business Park of Berkeley, Calif. “PTG

has developed an entirely new generation of biomaterials and has thus beena catalyst in the advancement of some remarkable medical devices that aresignificantly benefiting mankind,” says George Pitarra, President of Emer-gence and PTG’s Chief Financial Officer.

For more information: Robert S. Ward, Polymer Technology Group, 28107th Street, Berkeley, CA 94710; tel: 510/841-7800; www.polymertech.com;www.emergence-llc.com.

Congressional reform may weaken patent protectionThe Patent Reform Act pending in the U.S. Congress may weaken impor-

tant patent protections by making patents easier to challenge and cheaper toinfringe, says industry group AdvaMed. However, Sen. Orrin Hatch has re-portedly assured medical device manufacturers that he has stipulated the billis aimed at preserving innovation. Senate Judiciary Committee ChairmanPatrick Leahy and Ranking Member Hatch, along with other members fromboth parties, want to move forward with the bill early in 2008. The House haspassed its version of the bill, H.R. 1908, while the Senate version, S. 1145, hasbeen voted out of committee and is awaiting floor time.

Information on H.R. 1908 can be found at thomas.loc.gov/cgi-bin/bdquery/z?d110:h.r.01908. S. 1145 is available at thomas.loc.gov/cgi-bin/bdquery/?d110:s.01145.

INDUSTRY NEWS12

C.R. Bard Inc. announces that it hasreceived clearance from the U.S.Food and Drug Administration to

market its Agento IC silver-coatedendotracheal tube. The clearanceincludes claims for the reduction of

microbiologically confirmed ventilator-associated pneumonia

(VAP). In a multicenter clinical trialcomparing the Agento breathing tubeto an uncoated tube, the percentage

of patients who developed pneumonia was reduced from 7.5

percent to 4.8 percent. The Agentoalso delayed the onset of pneumonia.Holly P. Glass, C.R. Bard Inc., Murray

Hill, NJ 07974; tel: 703/754-2848;www.crbard.com.

Wright Medical Group Inc. has entered into an exclusive worldwidelicense and distribution agreement

with A.M. Surgical Inc., a companyfocused on providing endoscopic

soft tissue release products for orthopaedic and foot and ankle

surgeons. The ten-year agreementincludes all of A.M. Surgical’s current

and future products for the foot andankle market. John K. Bakewell,

Wright Medical Group Inc., Arlington,TN 38002; tel: 901/867-4527;

www.wmt.com.The FDA announces theavailability of a guidance

addressing medical deviceexportation under the FDA

Export Reform and Enhancement Act. The

guidance document provides information on

the statutory and regulatory requirements

for exporting FDA-regulated products. It

replaces a previous draftguidance to help industryunderstand and comply

with the act, which “significantly changed”the export requirements

for devices and drugs. Theguidance, “Exports Under

the FDA Export Reformand Enhancement Act of1996,” can be found at

www.fda.gov/OHRMS/DOCKETS/98fr/98d-0307-

gdl0002.pdf.

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INDUSTRY NEWSDSM to extend its material portfolio for orthopedics

Royal DSM N.V. announces the start of an initiative to enter the market of ultrahigh molecular weightpolyethylene (UHMWPE). The company will make significant investments in a research and develop-ment program focused on UHMWPE grades with optimized material properties, specifically aimed atcurrently unmet clinical needs in this orthopedic segment.

The program involves Oxford Performance Materials Inc. (OPM) and Xylos Corporation (Xylos). OPMdevelops and commercializes implantable grades of polyether ketone ketone (PEKK), a polymer that

belongs to a family of engineering plas-tics whose mechanical properties aremuch closer to the properties of humanbones than those of the metals that areoften used in bone replacements.

Xylos is a medical device companydedicated to delivering superior bioma-terials solutions. Based on its propri-etary biocellulose technology, Xylos isdeveloping a series of products for mus-culoskeletal repair that eliminate therisks and limitations associated withhuman and animal-derived materials.

For more information: Steve Hartig,Vice President of DSM Biomedical, P.O.Box 18, 6160 MD Geleen, The Nether-lands; tel. +31 (0)46 47 60278; www.dsmbiomedical.com.

14

SurModics has entered an agreement with OakRiver Technology to collab-orate on the development, manufacture, and distribution of advanced coatingequipment for the medical device industry. OakRiver has licensed SurModicscoating process knowhow and other intellectual property and will build highlyautomated equipment for medical device customers. One OakRiver equip-ment platform features the SurModics PhotoLink coating technology, whichis ideal for coating catheters, guide wires, pacing leads, and similar medicaldevices. A second OakRiver equipment platform is optimized for SurModicsdrug delivery polymer systems. SurModics and OakRiver will jointly marketthe coating equipment. www.surmodics.com

A U.S. patent to cover bone grafting materials comprising a porous ceramicor composite bone graft that contains pyrollidones (including N-methyl-pyrroli-done, NMP) has been granted to Inion Oy, Finland. The addition of NMP tosuch materials is believed to enhance the healing of bone by facilitating theaction of natural bone growth promoters at the fracture site. Potential appli-cations of this patented technology lie in the following areas: bone graft sub-stitution for spine fusion, bone loss from emergency trauma, and bone lossfrom cancer of the bone. Dr Auvo Kaikkonen, Chief Scientific Officer, Inion Oy,Finland; tel: 44 (0)1279 874 222; www.inion.com.


he Materials for Medical Devices Database isthe only comprehensive database created specif-

ically for medical device design. Its first Orthopedicrelease on materials for spinal devices, with asecond release specific to hip devices planned forearly 2008, are designed to provide researchers anddesigners with a comprehensive and authoritativesource of materials property data, biocompabilitydata, drug compatibilities, and surface treatmentmethods.

Such a resource must be backed by a significant,credible, and ongoing effort to collate, organize,and index relevant information. In this case, thedatabase results from thousands of hours of dataacquisition, peer-review, and verification by spe-cialists, supported by investment from ASM Inter-national, the U.S.-based materials information so-ciety; and Granta Design, a University ofCambridge spinout and leading authority in ma-terials information technology. An advisory com-mittee of industrial and academic experts guidesdevelopment.

All of the data is fully traceable to its sources. Itincludes thousands of citations to published liter-ature, FDA device approvals, manufacturers’datasheets, and web sites. It aids the identification,screening, and selection of material grades, manu-facturing processes, and suppliers for spinal andhip applications. The database can be accessedacross the Internet or installed on a corporate net-work. An access fee funds the continued develop-ment and updating of the database. This shared in-vestment model enables a unique informationresource with the scale, scope, and currency re-quired in this fast-moving market.

A strong financial case can be made for effectivematerials information management in medical de-vice companies. Since there is such a strong connec-tion between the performance of the material, andthe success and cost-effectiveness of the device, thisis a topic that device manufacturers cannot ignore.

Materials and biocompatibilityManufacturers of medical devices need access to

the widest and best range of materials data on bothengineering and biological properties, as well asthe practical application of materials in specific de-vices. The key word is “access:” the data must beoptimally structured to maximize its impact on thedesign and development process, and must be de-signed to be practical in complex, multi-user cor-porate environments.

The primary component of a best practice solu-tion is a peer-reviewed, authoritative database ofpublished materials information. Covering all pos-sible device materials requires a massive quantityof information, dispersed across a huge variety ofsources, and in different formats.

This presents a problem, particularly since mostpersonnel who need to make decisions based ontheir interpretation of this information are not ma-terials experts. Device manufacturers who can solvethis problem successfully can win considerablecompetitive advantage. This is especially true giventhe nature of the industry, with its need to balanceoften-conflicting goals of innovation, minimizingrisk, reduced time-to-market, product safety, andproduct efficacy – all at optimum profit.

Predicted return on investment (ROI) on easilyaccessible, accurate data is considerable. Our ex-

16

T

A materials database for medical devicesBest practice in the management of materials information saves money, cuts time to market, and can help to avoid corporate liability. A new database of materials for medical devices can help achieve this goal.

Raymond Sirochman ASM InternationalMaterials Park, Ohio

Arthur Fairfull, Neil Morgan, Stephen Warde, and David CebonGranta DesignCambridge, England


ample calculations, based on case studies of typicalmaterials information problems in medical devicedevelopment, illustrate how ROI could exceed $15for every $1 invested – even when only a singleproduct opportunity or process improvementproject is considered.

Materials engineering dataSelecting a material that satisfies specific mechan-

ical and physical design requirements, that isstraightforward to process, and that is cost-effec-tive can be challenging enough. Add the require-ment to remain undamaged by extensive operationin the in vivo environment, and we have the addi-tional need for biochemical un-derstanding.

It is much easier to navigatethis complex set of parametersif the right knowledge has beenabstracted and compiled bysubject matter experts, and ifuser-friendly tools are avail-able to apply that knowledgesystematically. This helps usersto converge on the subset ofmaterials possibilities thatmerit more detailed assess-ment.

The first requirement is forengineering information onthe different materials types— plastics, metals, composites,ceramics — that may functioneffectively in medical devices.However, this data is special-ized and complex. Evenstoring the name of each ma-terial requires a system to copewith different alloy composi-tions, grades of polymer, heattreatments of the same ma-terial, and so on.

Dozens of relevant proper-ties must be considered, suchas engineering properties, bi-ological response information,process performance qualifi-cation, and in-vivo fatigue life.Each property has its own con-ventions, units, measurementtechniques, and other subtleties. A property maybe represented by a single number, by a range rep-resenting its possible variation, or by a graphshowing how it varies with parameters such as tem-perature or chemical composition. The graph maybe defined by an expression, or by perhaps severalthousand individual data points — and its axes maybe defined on linear and/or logarithmic scales.

A truly effective materials information systemmust be able to collate, hold, analyze, and connectall of this data. Generic information systems or toolsdesigned for financial or general administrative in-formation do not cope well with these advancedand highly specific requirements. Specialist systemsare required.

Biological response dataThe need to consider biological response data

adds an additional dimension and a number of chal-lenges. Just as with engineering data, the informa-tion may be in complex scientific formats.

Especially for information relating to technolo-

gies that have not yet been approved in ex-isting devices, this data exists primarily inthe scientific literature – and thus (a) can bedifficult to locate and keep up to date; and(b) primarily involves written documents,with the data or graphs embedded in the text.

The scientific data is invariably not pre-sented in a format intended for design engi-neers, and include categories such as:

• Degradation behavior in body fluids • Blood compatibility, such as thrombo-

genicity • Soft and hard tissue response • Local and systemic toxicity, carcino-

genicity, etc… • Material, coating, and drug interactions,

to screen out non-viable combinations The requirement here is not to bypass the

role of biochemical and bioengineering experts. Instead, the goal is to provide ameans of abstracting and providing an

overview of the above topics compiled by subjectmatter experts, to assist the initial screening exer-cise and help to converge on the subset of possibil-ities that merit more detailed assessment.

For more information: Raymond Sirochman,ASM International, Materials Park, OH 44073; tel: 440/338-5418; [email protected]; www.asminternational.org.

17

Manufacturers of medical devices needaccess to the widest

and best range of materials data on both

engineering and biological properties,

as well as the practical application of

materials in specificdevices. The key wordis “access:” the data

must be optimallystructured to

maximize its impact onthe design and

development process.

The Materials for Medical Devices Database contains information about materials for cardiovascular and orthopedic devices.


BUSINESS BRIEFS18

Industry association Ad-vaMed says it is concernedabout a new competitive bid-ding program for clinical lab-oratory services after theCenters for Medicare & Med-icaid Services announcedthe San Diego area will be thefirst site for the project. Theprogram requires competi-tive bidding arrangementsfor diagnostic laboratorypayments under Part B ofMedicare, which may pre-vent smaller, specialized labsfrom competing with largerfirms.

Advanced Materials Inc.has successfully achievedISO 13485 certification,which signifies the positiveassessment of the com-pany’s medical device qualitysystem.

Alphatec Holdings has re-ceived 510(k) clearance fromthe FDA to market its ZodiacLuxe 4-mm diameter pediclescrew in concert with its Zo-diac spinal disorder solutionproducts.

Medical device start-up Ap-piades Meditech has devel-oped an electromagnetic de-vice that accelerates theunion process in bone frac-tures.

Biomet Inc. announces thecompletion of its merger withLVB Acquisition Merger SubInc., a wholly-owned sub-sidiary of LVB AcquisitionInc., which is indirectlyowned by investment part-nerships directly or indirectly advised or managed by TheBlackstone Group L.P.,Goldman Sachs & Co.,Kohlberg Kravis Roberts &Co. L.P. and TPG Capital.

Cordis Corp., a Johnson &Johnson subsidiary, an-nounces the completion ofpatient enrollment for its piv-otal trial for the ExoSeal Vas-cular Closure Device. The

ExoSeal features a syntheticbioabsorbable polymer andis being studied to determinewhether it can enable expe-dited hemostasis.

DePuy Orthopaedics Inc.has launched computer soft-ware designed to signifi-cantly enhance the field ofcomputer-assisted knee re-placement surgery. The CiEssential Knee System iscomputer software that pro-vides surgeons with a three-dimensional view of the kneejoint to help accurately alignimplants during knee re-placement surgery.

Edwards LifesciencesCorp. has received CE Markapproval for European com-mercial sales of its Sapientranscatheter aortic heartvalve technology with theRetroFlex transfemoral delivery system.

Inion, a company focusedon the development of novelbiodegradable medical im-plants, has received 510(k)regulatory clearance from the U.S. Food and Drug Ad-ministration (FDA) for ex-tended indications for itsInion Hexalon biodegradablescrew.

Medtronic Inc. has received510(k) marketing clearancefrom the FDA for the Com-plete SE (self-expanding) Bil-iary Stent System, which isindicated for use in the pal-liative treatment of malignant neoplasms in the biliary tree.

Orthofix International N.V.has acquired the rights to allof the intellectual property re-lated to the InSwing inter-spinous process spacer,which can be used in a min-imally invasive surgical pro-cedure involving minimal orlocal anesthesia.

Qinetiq North America an-nounces that its subsidiary,

Foster-Miller, has receivedinternational certification forquality management systemsfor both its CommercialEquipment and its Electronicand Electrical SystemsGroups.

Stryker introduces SDCUltra, an all-in-one medicalimaging information manage-ment system that archivessurgical images and videosand records surgical footagein HD quality.

Symmetry Medical Inc hasentered into a definitive agree-ment to acquire Specialty Sur-gical Instruments and UltraContainers of America, aleading provider of specialtysurgical instruments and ster-ilization containers, for $15.1million in cash on a debt freebasis, subject to certain ad-justments.

Ulbrich Stainless Steelsand Special Metals Inc. ispleased to announce the for-mation of Ulbrich of Austria,Gmbh. The new venture willbe part of the Ulbrich Spe-cialty Wire Group, which willnow consist of five produc-tion facilities in three coun-tries.

Wright Medical Group Inc.has acquired certain assetsof Metasurg, a company fo-cused on development andmarketing of surgical fixationand implant devices for footand ankle surgery. The pur-chase consists of an initialcash payment of $2.5 millionand potential additional cashpayments based upon futurefinancial performance of theacquired assets.

Zimmer Holdings Inc. andits indirect wholly owned sub-sidiary ZMH Acquisition Co.announce that they havebeen successful in their bidto acquire OrthoSoft Inc., aleader in computer naviga-tion for orthopedic surgery.

Harvard physicists have

shown that specially treated

diamond coatings cankeep water

frozen at bodytemperature, a

finding that may have

applications infuture medical

implants.

NorthwesternUniversity

researchershave shown thatnanodiamonds

are very effective at delivering

chemotherapydrugs to cellswithout the

negative effectsassociated with

current drug delivery agents

IsoTis Inc., anIrvine maker ofartificial bone

material, is beingacquired by

Integra LifeSciences

Holdings Corp.for $51 million.

BioMedical Enterprises Inc.has launched anew medical

product, a Nitinolimplant designed

to fix irregular bonesurfaces and

structural problems in bone

anatomy.

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PRODUCTS & SERVICES20

Surface treatmentsActeron Corp., San Carlos, Calif.,

offers coatings and surface treatments for medical devices.processes include electropolishing,Plating, and anodizing of gold, plat-inum, rhodium, and other materials.www.acteron.com

Biomedical alloysAdmedes Schuessler, West

Chester, Pa., offers a variety of serv-ices, including laser machining,micro-joining, and electro-polishingin a variety of materials, includingNitinol, cobalt alloys, titanium alloys,stainless steel, tantalum, and niobium. www.admedes.com

Quality certificationAdvanced Materials Inc., Dallas,

Texas, announces that it has suc-cessfully achieved ISO 13485 certi-fication, which signifies the positiveassessment of the company’s med-ical device quality system. www.amit.com

Biomedical alloy powdersAdvanced Specialty Metals,

Nashua, N.H., offers pure and alloypowders made via PREP (plasma ro-tating electrode powder) from theentire range of metals (aluminum tozirconium), including F-75 cobaltalloy, rare earth, superalloy, and ti-tanium. In addition, we providecustom manufacturing services tai-lored to customer specifications.www.asmpowders.com

Abrasive comparison chartAllied High Tech, Rancho Domin-

guez, Calif., offers an Abrasive & Di-amond Lapping Film Slide Chart. Itfeatures an abrasive grade compar-ison chart on one side to help com-pare U.S. Industrial Grit, FEPA (Eu-ropean) P-Grade and Micron sizesfor abrasives. The other side of thechart compares the different micronsizes of diamond lapping film, thesurface finish each gives, and thecommon applications for it. www.alliedhightech.com

Triple clad wireAnomet Products, Shrewsbury,

Mass., offers precious metal-cladwire and ribbon as a cost effective

alternative to solid wire while of-fering greater ductility and forma-bilty than filled or plated wire.Clad-wire features a complete met-allurgical bond between layers.Metals include platinum for oxida-tion-corrosion resistance and bio-compatibility, gold for contact re-sistance, and palladium or silver. www.anometproducts.com

Artificial musclesArtificial Muscle Inc., Menlo Park,

Calif., has developed electroactivepolymer artificial muscle (EPAM) formedical devices. The basic EPAMdevice is made of a electrically con-ductive polymer coated on bothsides with another electrically con-ducting material that serves as anelectrode. When voltage is appliedto the two electrodes, a Maxwellpressure is generated, causing me-chanical motion. www.artificialmuscle.com

Bioactive coatingsAPS Materials, Dayton, Ohio, pro-

duces both porous and bioactivecoatings of commercially pure tita-nium and its alloys, as well as hy-droxyapatite, for biomedical im-plants. Materials are applied by arcplasma spray, in which droplets ofmolten materials are sprayedagainst an appropriate substrate. www.apsmaterials.com

Characterization of biomaterialsThe Bose BioDynamic test instru-

ment provides precise characteri-zation of biomaterials and biologicalspecimens within a closed saline orcell culture media environment. It isavailable either as a dedicated desk-top instrument or as an accessoryto an existing ElectroForce system.www.bose-electroforce.com

Welding simulation toolThe Edison Welding Institute,

Columbus, Ohio, has launched anew online weld simulation tool, E-Weld Predictor, offering improvedproductivity and profitability to itscompanies. This on-demandproduct will allow welding engineersto evaluate the changes in temper-ature profiles, material micro-struc-tures, residual stresses, and weldingdistortion. www.ewi.org

Orthopedic wireFort Wayne Metals, Fort Wayne,

Ind., provides centerless ground barand wire products for the orthopedicindustry. A variety of coated wire andcable configurations comprising abiocompatible sheath, lubriciousbarrier, or other medical grade ma-terial are available in stainless steel,titanium, Nitinol, and more. www.fortwaynemetals.com

Materials selectionGranta Design Ltd., Cambridge,

England, has prepared a whitepaper, Materials Information in Med-ical Device Design. This white paperexamines the need for best practicein the management and use of ma-terials information, the requirementsthat best practice imposes, and howthese requirements can be met.Download is free. www.grantadesign.com.

Metal strip and foilHamilton Precision Metals, Lan-

caster, Pa., rolls metal strip and foilin nearly any alloy and specialtymetal to the tightest tolerances andthinnest gauges in the industry —down to 1.5 microns in thickness.Metals include stainless steels,nickel and nickel alloys, titanium andits alloys, and copper and its alloys.www.hpmetals.com

Durability testingInstron, Norwood, Mass., offers

FastTrack 8800 fatigue systems,which are ideal for durability testingof artificial heart valves and the ma-terials used in their production. Thesystems are capable of running dy-namic tests across a wide frequencyrange of elastomeric materials. www.instron.com

Seminars at a Glance

Stainless Steels, Cobalt-Chromium and Titanium Alloys for Medical Devices Phillip J. Andersen, PhD

Medical Device Design Validation and Failure Analysis Brad James, PhD, PE

Inorganic PVD Coatings and Surface Treatments for Medical Devices Dr. David Glocker

Materials Selection: Meeting Functional Requirements of Medical Devices Michael N. Helmus, PhD

Seminar Dates:

Plymouth, Indiana May 19-23, 2008

Minneapolis, Minnesota June date to be announced

Cleveland, Ohio August 4, 2008

Palo Alto, California September date to be announced

Miami Florida December 8-12, 2008

You may attend one or more of the full-day seminars or the entire five-day series. Multiple students from your organization can sign up and receive a discount. For details, contact [email protected], or call 800.336.5152 or 440.338.5151, ext. 0.

Visit us online at www.asminternational.org/training

Phillip J. Andersen, PhD

Brad James, PhD, PE

Polymer Considerations in Medical Device Design Jennifer M. Hoffman, PhD

Nitinol for Medical Devices Presented by SMSTSM

Scott Russell

Dr. David Glocker

Michael N. Helmus, PhD

Jennifer M. Hoffman, PhD

Scott Russell

Attend one of ASM’s upcoming seminars to gain the materials knowledge you need to become an innovator in your industry!

Materials KnowledgeLeads to Better Medical Devices

a materials database for medical

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