BONE CATALOG FOR ORAL SURGERY

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PURPOSEFULLY

WORKING TO IMPROVE MEDICALCARE IN TAIWAN

At Medtronic, we are more than the leading medical technology company – we are dedicated to helping solve healthcare’s biggest challenges.

By finding new ways with new partners to create new opportunities, we can help better serve the needs of healthcare systems and patients around the world. We each play an important role in driving change and helping to share what Medtronic stands for and is capable of – all with the goal of achieving our Mission to alleviate pain, restore health, and extend life.

INTRODUCTION

Healthcare systems face serious challenges. An aging population, limited access to care and rising costs place a heavy toll on patients and their families, as well as the healthcare businesses, budgets, and the Taiwanese government and taxpayer. These systems cannot sustain their current course. It is only by improving patient outcomes, optimizing costs, and expanding access that we can counter these growing demands.

At Medtronic, we’re committed to playing a central role in solving these issues. And our commitment is what sets us apart from others. Our scale and breadth of resourcesenable us to stretch further and reinforce our dedicationto help lead a global transformation in healthcare.

IMPROVE

CLINICAL OUTCOMES

EXPAND

ACCESSOPTIMIZE

COST ANDEFFICIENCY

MASTERGRAFT® Granules

MASTERGRAFT® Resorbable Ceramic Granules are indicated only for bony voids or gaps that are not intrinsic to the stability of the bony structure. MASTERGRAFT® Resorbable Ceramic Granules are to be gently packed into bony voids or gaps of the skeletal system (e.g., bone defects in oral surgery, extraction sites).These defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone. MASTERGRAFT® Resorbable Ceramic Granules provide a bone void filler that resorbs and is replaced with bone during the healing process.

Medical-grade Polyporous Resorbable Ceramic Granules

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Granules are composed of:

)PCT-β(

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of minerals similar to those found in bone.To provide an osteoconductive porous scaffold composed

– Both HA and -TCP contain calcium and phosphate - the principal constituents of bone.HA is the primary mineral found in bone matrix. –

» HA and β-TCP are the two most widely studied ceramics used for bone grafting applications, supported by more than 20 years of clinical experience.

» The combination of HA and β-TCP provides an engineered combination of the desired characteristics:

– Long-term stability. – Resorption.

30% to 35% Organic Matrix

65% to 70% Mineral

(β-TCP)

Bone Composition

Chemical Composition

Why Are the Granules Composed of 15% HA and 85% β-TCP?

Brief Summary

Features

» 80% porosity. » 500 micron average pore size. » 125 micron average interconnected diameter.

Physical Properties of Resorbable Ceramic Granules

15% hydroxyapatite (HA)85% beta-tricalcium phosphate

125 Microns

500 Microns

x 25 Magnification

Potential Benefits

» Aids osteointegration. – rof dloffacs a sa gnitca yb ssecorp gnilaeh enob eht stroppuS

new bone formation. – eht ecalper yllaudarg ot noitutitsbus gnipeerc swollA

MASTERGRAFT® Granules with new host bone. » Supports mature bone growth throughout the entire defect site.

– dna selunarG ®TFARGRETSAM neewteb sdnob gnorts smroF natural bone surrounding the defect.

– etis tcefed eht tuohguorht desrubsid era selunarg laudiseR and are in direct contact with woven bone and osteoid.

» Designed to facilitate the regeneration of bone prior to complete resorption.

– .htworgni ynob rof swollA – ot roirp noitproser etelpmoc sdiova noitisopmoc cisahpiB

bone regeneration.

The Resorbable Advantage

Product Ordering InformationProduct Information

Chemical Composition

Physical Structure

Granular Size

Granular Porosity

Average Pore Size

Resorption Rate

FDA 510(k) Clearance

)PCT-β(15% hydroxyapatite (HA)

Homogenous 3-dimensional macroporous structure

1.6mm ~ 3.2mm

7600110

7600105

10 cc vial

5.0 cc vial

80%

500 Microns

Resorbs in approximately 6 months

Bone void / defect filler

85% beta-tricalcium phosphate

MASTERGRAFT® Granules placed in extraction socket

Final restoration at 6 monthspost implant placement

Implant placement at 4 months post-extraction

Nonrestorable tooth #9

Clinical Trial

Above: H & E histological analysis of core samples taken from MASTERGRAFT® Granules augmented extraction site bone. New bone formation is seen around MASTERGRAFT® Granules.

In seven patients, between the ages of 35 and 82, Mastergraft Granules were used to graft an extraction socket defect to preserve ridge form after tooth extraction.

This medical product indicated for oral surgery is registered with the Taiwan Food And Drug Administration under the Taiwan (ROC) Ministry of Health.

MASTERGRAFT Granules 為可吸收的化學合成骨,由15%的氫氧磷灰石 (HA)和85%的β-磷酸三鈣(β-TCP)而組成的陶瓷晶粒。

一個自然的,相互聯結的多孔結構,它近似天然骨的結構,能 讓骨細胞快速均勻深入整個顆粒的孔洞而生長,進而轉換為成 骨。針對骨缺陷 MASTERGRAFT® 提供了可吸收的骨間隙填充物,並於癒合過程中由骨組織取代之。

MASTERGRAFT Granules 顆粒的平均直徑為 1.6mm - 3.2mm。百分之八十都是孔洞結構,這些大 大小小的孔洞平均孔徑為500微米和125微米直徑並且相互連結。

Clinical Case

REFERENCES:1 Hing, et al. Comparative performance of three ceramic bone graft substitutes. Spine Journal. 2007;7:475-490.

Notes:* From animal study on le. Animal studies are not necessarily predictive of human clinical outcome.** Data on file.

內含之化學成分有助於骨整合一致且均勻的物理結構較佳(更為均勻)顆粒孔隙可吸收, 約6*個月內轉換為成骨 **

Indications

GRAFTON® Demineralized Bone Matrix is indicated as a bone graft extender, bone graft substitute, and bone void filler to fill bony voids or gaps not intrinsic to the stability of the bony structure.

Contraindicated for use in the presence of infection at the transplant site.

Brief Summary

GRAFTON DFDBADBM Product Family

®

GRAFTON DBM contains demineralized human bone tissues recovered from cadaveric donors using aseptic surgical techniques, and is microbiologically tested during recovery. It is combined with USP anhydrous glycerol to yield a demineralized bone matrix (DBM) allograft product.

GRAFTON DBM Gel is produced from a powder form of DBM while GRAFTON Putty, and Crunch are produced from a fiber form of DBM. GRAFTON DBM Crunch also contains demineralized bone chips/cubes. GRAFTON DBM products are pliable and can be moulded or cut into various sizes and shapes as per implant site indications.

GRAFTON DBM are demineralized bone allograft products that are absorbed/remodeled and replaced by host bone during the healing process. Average resorption time is 2~3 months.

Demineralized bone fibers (DBM)

Use of Matrix Plugs in Extraction Sites

Clinically Proven Bone Graft Substitute

Uses of GRAFTON DFDBA DBMin Oral Surgery

Validated for osteoinduction in an in vivo model

Superior osteoconduction through Bone Fiber Technology

Multiple forms deliver excellent handling characteristics for different site indications

Biocompatible with a history of safety

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Only GRAFTON DBM is indicated as a bonevoid filler, bone graft extender, and bonegraft substitute

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Extraction Site Grafting - simple to use, effective, and cost efficient. Matrix Plugs are recommended for this procedure.

Sinus Grafting - Gel and Putty are ideal for this procedure and are usually combined with MASTERGRAFT Granules.

Periodontal Regeneration - proven to regenerate bone, cementum, and periodontal ligament, Putty is ideal for intrabony defects.

Ridge Augmentation - We recommend use of Gel, Putty, or Matrix Plugs to provide lateral bone augmentation in wall defects.

The Resorbable Advantage

GRAFTON Product Range

This medical product indicated for oral surgery is registered with the Taiwan Food And Drug Administration under the Taiwan (ROC) Ministry of Health.

GRAFTON® DBM 為去除礦物質後的人骨組織,經添加一種 惰性的添加劑,製成去礦化骨基質(DBM)的異體移植產品。 GRAFTON® DBM 提供多種形態,如:凝膠(Gel)是由粉狀的去 礦化骨基質製成,薄片(Flex),泥膠(Putty),基質(Matrix),去礦骨 粒泥膠(Crunch)是由去礦化骨基質纖維製成,內含有骨碎片或 骨粒。GRAFTON® DBM 的產品柔軟及易塑性,可依據植入位 置擷取所需尺寸和形狀使用。

GRAFTON® DBM 是採集自捐贈的人體骨組織,以無菌手術技 術取得組織並經微生物測試合格後, 該組織進而在無菌環境 下製造。並混合無水甘油(符合美國藥典)形成最終的骨移植 產品。

GRAFTON DBM 為可吸收, 能在癒合過程中被宿主骨頭吸收, 重塑並取代之。平均吸收時間為2~3個月,但仍取決於適應 症和患者的年齡。

GRAFTON DBM 去礦化骨基質是 Medtronic 公司的專利方法製造,經證實其製造過程所 產生的去礦化骨基質能維持無胸腺鼠文獻中 所說的骨誘導性功效。目前只有GRAFTON DBM 被公認是一個對於骨間隙填充物,植骨 延長和骨移植替代的最佳基質。

Clinical Case - Putty: 44yr, F, Banciao, Taiwan.

17年以上的安全性和臨床上的成功

全世界近百萬例手術使用

經證實具骨誘導

唯一經過驗證能生產具誘導性去礦化骨基質

獨步全球的傳導因子滲透骨纖維的科技技術

安全的生物相容性歷史

提供多種形態,方便臨床應用。

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consists of demineralized bonefibers and can be mixed with either allograft or autograft bone

Oral, Spine, Trauma, Pelvis and ExtremitiesCOMMON USES

can be injected percutaneously and canbe mixed with cancellous chips / granules

Oral, Trauma and ExtremitiesCOMMON USES

REF. NO. DESCRIPTION

P41120 GRAFTON® Gel 1.0 cc

REF. NO.

P43102P43103P43105

GRAFTON® Putty 1.0 ccGRAFTON® Putty 2.5 ccGRAFTON® Putty 5.0 cc

DESCRIPTION

REF. NO. DESCRIPTION

P42308INT GRAFTON® Matrix0.8 cm x 1 cm x 1 cm

a firm cube of bone fiber matrixthat facilitates filling extraction sites and bone defects.

Oral Extraction sites, SpineCOMMON USES

Brochure No: P/16/Q1/MedtronicCatalog