Providing the total solution to yoursingle-incision laparoscopy needsA Value Proposition from Covidien

1. An introduction to the single-incision laparoscopic technique The evolution of minimally invasive surgery

2. Realising single-incision laparoscopic surgery with the Covidien SILSTM Port The first device indicated for multiple-instrument access through a single incision

3. Covidien’s total service partnership Working with customers at every stage to achieve optimal outcomes

4. Covidien SILSTM product portfolio Innovative products for effective single-incision laparoscopy

5. Clinical evidence to support the Covidien SILSTM Port Ongoing clinical evaluation of the Covidien SILS™ Port

6. About Covidien Leading in surgical instrumentation and delivering value through clinical leadership and excellence

Contents

As a market leader in minimally invasive surgery instrumentation, Covidien is meeting today’s new

surgical challenges with the SILS™ portfolio

Providing the total solution to yoursingle-incision laparoscopy needs

1. An introduction to the single-incision laparoscopic techniqueb

Advancing surgical techniques to improve patient outcomes

The surgical arena is constantly evolving and the search for less-invasive procedures with clinical and healthcare benefits over open surgery has focused on reducing the size and number of incisions required.

Laparoscopy is a minimally invasive technique that has replaced open surgery for many surgical procedures

First identified as a method of surgical access in the early 1900s, and having become an established surgical technique in the 1990s, laparoscopy is now acknowledged as one of the twentieth century’s most significant surgical advances.

Indeed, laparoscopy is now considered the ‘gold-standard’ for a number of common surgical procedures, replacing open surgery. By replacing one large incision with three or four smaller incisions, a significant advantage has been gained in terms of post-operative pain, recovery time and aesthetic result.

Single-incision laparoscopic procedures are an evolutionary step in minimally invasive surgery

Building on the success of conventional laparoscopic procedures, the single-incision laparoscopic technique takes minimally invasive surgery one step further. It is performed via a small (approximately 20 mm), single incision in the umbilicus, thereby reducing the number of access points required compared with conventional laparoscopic procedures, and has the potential to offer a number of clinical benefits over laparoscopic and open surgery.

Single-incision laparoscopy has now been used for a wide range of general and complex surgical procedure types1-26, all of which have been successfully carried out using Covidien SILS™ instrumentation.

The evolution of minimally invasive surgery

Procedure characteristics•Typically anything up to a 15

cm incision

•Large scar

•Hospital stay: 3–7 days

•Moderate pain

•Return to work in up to 6 weeks

The above illustrations are typical examples for a Cholecystectomy

Procedure characteristics•Up to four small

incisions

•Three or four small scars

•Hospital stay: 1–3 days

•Mild or minimal pain

•Return to work within 5–10 days

Procedure characteristics•One small, 20 mm incision

•Potential for no visible scar

•Hospital stay: 1–3 daysa

•Mild or minimal pain; may potentially eliminate the pain from multiple sites of entrya

•May potentially return to work within 5–10 daysa

Opensurgery

Conventionallaparoscopic

surgery

Single-incisionlaparoscopic

surgery

a Potential benefits: currently under investigation in clinical trials (see section 5) b The potential benefits described cannot be related to the Covidien SILS™ Port. Clinical studies are underway to establish if the benefits of the single-incision technique can be expected from the SILS™ Port.

Potential benefits of single-incision laparoscopy b

· Potential for no visible scarring· Elimination of pain from multiple sites of entry· Quicker time to recovery compared with open surgery.

2. Realising single-incision laparoscopic surgery with the Covidien SILS™ Port

Single-incision laparoscopic procedures represent an evolutionary step towards the ideal of natural orifice translumenal endoscopic surgery (NOTES) and Covidien is at the forefront of this technology: the Covidien SILS™ Port is the first device specifically indicated for multiple-instrument access through a single incision.Launched in early 2009, the Covidien SILS™ Port has already been nominated by the UK National Health Service as one of the ‘Top 10 innovations of 2009’,27 confirming Covidien’s role as a leader in surgical innovation.

Key features of the Covidien SILSTM Port

The multi-channel-access SILS™ Port is inserted into a 20 mm incision in the umbilicus, in combination with articulating instrumentation (e.g. SILS™ hand instrumentation; see section 4), allowing surgical procedures to be carried out through a single incision.

Constructed in flexible soft-foam, the SILS™ Port will conform to the body’s contours to maintain pneumoperitonaeum and, with access channels for three cannulae (ranging between 5 mm and 12 mm), will adapt its configuration to the size of each cannula. A two-way stopcock allows for easy insufflation or smoke evacuation.

Utilising the umbilicus as the point of surgical entry reduces visible scarring compared with conventional laparoscopic surgery, leading to improved cosmesis.

The Covidien SILS™ Port has been used successfully in a number of different surgical procedures, including:

Adrenalectomy

Appendectomy

Cholecystectomy

Colectomy

Diagnostic laparoscopy

Fundoplication

Gastric banding

Gastric bypass

Hernia repair

Hysterectomy

Liver resection

Nephrectomy

Oophorectomy

Prostatectomy

Sleeve gastrectomy

Splenectomy

Tubal ligation

Covidien SILSTM Port

The SILS™ Port has been nominated by the UK National Health Service as

one of the ‘Top 10 Innovations of 2009’ 27

3. Covidien’s total service partnership

Covidien is committed to offering a ‘total service partnership’ to ensure that its customers are fully supported at every stage, resulting in more efficient single-incision laparoscopic procedures and leading to better patient outcomes. From providing a full training pathway for surgeons, through to technical support from certified surgical product specialists in the operating room, and patient education materials for hospitals, for example, Covidien works closely with customers at every stage of the single-incision laparoscopy adoption process as part of a comprehensive added-value offering. Customised containment kits comprising preferred Covidien SILS™ instrumentation and appropriate cost controlled supplies further ensure that each surgical team’s requirements are met.

The Covidien total service partnership for single-incision laparoscopy

A unique partnership approach

KEY FEaTurES

• One point of contact

• 24/7 assistance

• Pre-training mentoring

• Bespoke training

• Bespoke resources

• Workshops

• Bespoke kits

• Preliminary support

• Masterclass programme

• Clinical immersion

• Mentorship

• Newsletter

• FAQ document

• Media kit

• Meeting resources

• Grand rounds presentation

• Clinical publications

• Patient case studies• Primary-care physician guide• Patient materials

CuSToMEr

Surgeons and their surgical teams

Surgeons and their surgical teams

Surgeons and their surgical teams

Business managers

PR teams

Patients

SErvICE

Technical Support(from certified surgical product specialists)

Training pathway

Materials and resources

Covidien’s certified surgical product specialists

Covidien’s certified surgical product specialists are at the forefront of Covidien’s collaborative approach, providing technical help and support to our customers around the clock.

Fully trained in single-incision laparoscopy with the Covidien SILS™ Port, each surgical product specialist is qualified to provide surgeons and their surgical teams with advice and technical knowledge on all aspects of single-incision laparoscopy.

As a key point of contact throughout the procedure pathway, each surgical product specialist will work closely in partnership with surgeons and their surgical teams.

From providing technical support in the operating theatre through to identifying any individual training needs, developing bespoke training packages and promoting best practice, surgical product specialists offer added value to the surgical teams as part of Covidien’s comprehensive partnership approach.

The Covidien training pathway

Central to Covidien’s total service partnership offering is a dedicated training and mentoring pathway for surgeons and their surgical teams.

From providing preliminary educational materials, to running training masterclasses and hands-on workshops with world-class surgeons, Covidien is focused on providing in-depth education and training, to help reduce the learning curve and thereby shorten the longer initial operating times that may be associated with the adoption of a new technique.

A structured clinical immersion programme is available following the masterclass, which involves the trainee visiting a hospital that has extensive experience with the single-incision laparoscopic technique to observe and/or participate in procedures with an expert surgeon and to receive in-depth practical guidance.

This experience can then be reinforced by a mentorship programme, which involves the expert surgeon visiting the trainee’s hospital to provide further training and development during the early stages of the adoption process.

Covidien offers training support at every stage of the procedure adoption process

PaCE* advanCEd TraInIng 2009 ovErvIEw Surgeons trained One/two-day sessions at Covidien and other facilities 6585

Nurses trained One/two-day sessions at Covidien and other facilities: 2175

Clinical immersion sessions Multi-day training sessions led by world-class surgeons: 376

Masterclasses One/two-day sessions at Covidien and other facilities: 69

Surgeries covered New SILSTM, hernia repair, laparoscopic procedures and others: 2

*PACE - Professional Affairs & Clinical Excellence

*Please note: Clinical Immersion and Mentorship programmes available on request

Preliminary support

1. Questionnaires

2. Pre-course materials •Clinicalpublications •Podcasts •Step-by-stepguides •ProceduralDVDs •Simulators

Mentorship*

1. Experienced surgeon visits trainee at own centre

2. In-depth practical guidance and support

3. Access to patient education resources

4. Patient literature

5. Patient charts

Masterclass programme

1. Hands-on workshops (using simulators)

2. Business case for single-incision laparoscopic procedures

3. Ethical guidelines

4. Web resources

5. Expert support networks for trainees

Clinical immersion*

1. Trainee visits expert surgeon at experienced centre

2. Exposure to numerous single-incision laparoscopic procedures

3. Participation/observation in procedures

4. In-depth practical guidance and support

Covidien’s state of the art European training centre: Élancourt Paris, France

At Élancourt, Covidien offers advanced surgical training courses as part of the Covidien training pathway. Led by world-renowned surgeons, these masterclasses aim to enhance surgical skills in advanced procedures, including single-incision laparoscopy with the Covidien SILS™ Port, through a programme of lectures and practical skills training.

‘About 2 years ago, Covidien started a dedicated training programme that allows surgeons (experienced in laparoscopic surgery) to become familiar with all aspects of single-incision laparoscopy and then safely practice the novel technique. Subsequent clinical immersion at centres of excellence and proctoring in the local setting complete the training. This pathway is regarded as one of the mandatory steps that must be undertaken before including the SILS™ technique in the routine surgical armamentarium.’

Professor Helmut Weiss, Head of Surgical Department, St John of God (SJOG) Hospital, Salzburg, Austria

Covidien recognises that more than just clinical support is required for surgeons and hospital managers to maximise opportunities for single-incision laparoscopic procedures.

In line with this, Covidien has developed a wide range of materials, which together with a tailored clinical-support programme, forms a total solution for surgeons and their surgical teams, hospital managers and procurement officers:

Materials to support surgeons/hospitals in making informed decisions on introducing single-incision laparoscopic procedures:

•FAQdocumentc: answering questions commonly asked by decision-making parties

•Newsletterc: including expert surgical opinion on single-incision laparoscopic surgery

•Resourcelibraryc: including publications, podcasts and procedural DVDs.

Materials to support surgeons/hospitals in raising awareness of single-incision laparoscopic surgery:

•Mediakitd: including press releases, fact sheets, advertisements and presentations

•Primary-carephysicianguidec: to single-incision laparoscopic procedures

•Grandroundspresentationc

Materials to support surgeons in their patient communications:

•Patientguidec: to single-incision laparoscopic procedures

•Informationsheetsc: covering specific surgical fields, including general surgery,urology, gynaecology and colorectal procedures

•Patientflipchartc

•Patientcasestudiesc

•Patientwebsitesc: www.mygallbladderinfo.com www.sils.com/hysterectomy www.sils.com/bellybuttonsurgery

More than just clinical support: The Covidien total solution

c: available now d: available soon

To SuPPorT THE SurgEon

To SuPPorT THE HoSPITaL

Media kit

PCP guide

Newsletter

Patient case studies

To SuPPorT THE PaTIEnT

Training pathway

DVD Port insertion guide

Clinical papers

Step by step guides

SILSTM website

FAQ document

Case studies template

Patient guide

Patient flipchart Patient websites

Patient literature

4. Covidien SILSTM product portfolio

The Covidien SILS™ product portfolio has been developed in close collaboration with surgeons and their surgical teams. Innovative design ensures that the Covidien SILS™ Port, SILS™ hand instruments, SILS™ Stitch and Roticulator™ instruments offer surgeons the correct degree of articulation and rotation for optimal access through a single incision.

A continuing commitment to surgical advancement

Building on previous innovative successes, Covidien will continue to work closely with minimally invasive surgery specialists worldwide to develop the next generation of surgical tools and to continue to help surgeons and their teams deliver the highest possible level of patient care.

In 2009 the US Patent Board ranked Covidien as the number-one innovator within the medical devices and services industry, above 121 other companies.

Rank is awarded not just for number of patents granted, but also for the strength of the science and healthcare industry impact.

SILS™ Hook

SILS™ Stitch

Innovation delivered

SILS™ Port Procedure Kit

SILS™ Clinch

SILS™ Shears

SILS™ dissector

SILS™ roticulator™

Endo grasp

SILS™ roticulator™

Endo dissect

SILS™ roticulator™

Endo Mini Shears

5. Clinical evidence to support the Covidien SILSTM Port

Covidien is committed to advancing minimally invasive surgical techniques and believes that collaborative research is central to achieving this goal.

Covidien is partnering with minimally invasive surgery specialists to expand the clinical evidence on single-incision laparoscopic surgery with the Covidien SILS™ Port.

Covidien’s commitment to the ongoing clinical evaluation of single-incision laparoscopic surgery

Covidien is committed to the ongoing clinical evaluation of single-incision laparoscopic surgery to provide surgeons and business managers with the clinical evidence that they require to make an informed decision on the use of this technique on their patients.

Prospective, randomised, controlled trial of SILSTM Port laparoscopic cholecystectomy versus conventional laparoscopic cholecystectomy

Working with academic centres in Europe and the USA, Covidien is conductingalarge,PhaseIVpost-marketingstudyto:

1. Assess the feasibility and safety of laparoscopic cholecystectomy using the Covidien SILS™ Port.

2. Monitor and compare the outcomes of laparoscopic cholecystectomy using the Covidien SILS™ Port versus conventional four-port laparoscopiccholecystectomy.

The study is designed to assess Covidien SILS™ Port cholecystectomy versus conventional four-port laparoscopic cholecystectomy in approximately 200 adult patients, 18–85 years of age, with a body mass index <45 kg/m2, and with a diagnosis of biliary colic with documented gallstones or polyps by imaging or biliary dyskinaesia, with documented gallbladder ejection fraction <30%.

Phase IV clinical trial: Participating centres

Case Western Reserve University Cleveland, OH, USA

Catholic University of the Sacred Heart, Rome, Italy

Cleveland Clinic Cleveland, OH, USA

Columbia University New York, NY, USA

Emory University Atlanta, GA, USA

Drexel UniversityPhiladelphia, PA, USA

Imperial College London, UK

Southwestern Medical SchoolUniversity of Texas, TX, USA

Tufts UniversityBoston, MA, USA

University of CaliforniaIrvine, CA, USA

University of CaliforniaSan Diego, CA, USA

ouTCoME MEaSurES TIME FraME

Primary

Secondary

Outcome measures of a Phase IV trial of Covidien SILS™ Port laparoscopic cholecystectomy versus conventional four-port laparoscopic cholecystectomy

A collaborative approach to clinical research

‘Working in partnership with Covidien, we have almost completed a prospective, randomised study investigating SILS™ cholecystectomy versus standard four-port laparoscopy. This will be a very important study, which we hope will give us some real answers about the benefits of a single-incision approach versus conventional laparoscopy.’

Dr Roberto M Tacchino, MD, Assistant Professor of Surgery, Department of Surgery, Catholic University of the Sacred Heart, Rome, Italy

Feasibility and safety of SILSTM Portcholecystectomy as determined by intra-operative and post-operative adverse events

Pain

Quality of life/time to return to normal activity

Cosmesis

Ten time points up to 1 year post-operation

Seven time points up to 1 month post-operation

Six time points up to 1 month post-operation

Five time points up to 1 month post-operation

6. About Covidien

Covidien is one of the largest global manufacturers in the healthcare industry, offering an extensive product portfolio that spans medical devices, pharmaceuticals and medical supplies

The Covidien story

As the fifth largest healthcare products company in the world, with more than 42,000 employees in more than 60 countries, Covidien is passionate about helping doctors, nurses, pharmacists and other medical professionals achieve the best patient outcomes.

By identifying clinical needs and formulating solutions in the form of proven products and procedures, Covidien has demonstrated its commitment to creating innovative medical solutions for better patient outcomes. Covidien’s industry-leading brands are sold in more than 140 countries worldwide and are well known and respected in the healthcare field, recognised by their uncompromising quality and reliability.

The Covidien partnership approach

Covidien is dedicated to developing and maintaining strong relationships with all customers in all business segments and offers support with continuing education programmes, including extensive clinical education in dedicated trainning centres.

Collaboration is recognised as one of Covidien’s core values. By working closely with its customers, other medical professionals and organisations, Covidien continues to produce healthcare solutions and deliver value through clinical leadership and excellence.

The Covidien commitment to innovation

Covidien is committed to creating innovative medical solutions for better patient outcomes and has pioneered a number of medical advances including contrast media, electrosurgery, laparoscopic instrumentation, pulse oximetry and surgical stapling.

To continue to build on this success, Covidien has a continuing commitment to research and development investment.

Covidien is leading the way in surgical instrumentation by creating and offering innovative medical solutions for better

patient outcomes and delivering value through clinical leadership and excellence in everything it does

Covidien business segments

Imaging solutions: includes radiopharmaceuticals and contrast products.

Medical devices: includes endomechanical, soft tissue repair, energy, oximetry & monitoring, airway & ventilation, vascular and other products.

Medical supplies: includes nursing care, medical surgery, SharpSafety and Original Equipment Manufacturer (OEM) products.

Pharmaceuticals: includes speciality pharmaceuticals, active pharmaceutical ingredients and speciality chemicals.

References and further information

Covidien (uk)

Commercial Ltd 154 Fareham RoadGosport Hampshire PO13 0ASUnited Kingdom

+44 (0) 2030 271757 [t]+44 (0) 2030 271758 [f]

www.covidien.com

For more information on single-incision laparoscopy, the Covidien SILS™ Port and associated instrumentation, please visit:www.sils.com www.sils.com/bellybuttonsurgery www.sils.com/hysterectomy www.mygallbladderinfo.comAlternatively, please contact your local Covidien representative.

1. Chow A, Purkayastha S, Paraskeva P. Appendicectomy and cholecystectomy using single-incision laparoscopic surgery (SILS): the first UK experience. Surg Innov 2009;16:211–17

2. Piskun G, Rajpal S. Transumbilical laparoscopic cholecystectomy utilizes no incisions outside the umbilicus. J Laparoendosc Adv Surg Tech A 1999;9:361–4

3. Cuesta MA, Berends F, Veenhof AA. The “invisible cholecystectomy”: a transumbilical laparoscopic operation without a scar. Surg Endosc 2008;22:1211–13

4. Petrotos AC, Molinelli BM. Single-incision multiport laparoendoscopic (SIMPLE) surgery: early evaluation of SIMPLE cholecystectomy in a community setting. Surg Endosc 2009 Mar 6 [Epub ahead of print]

5. Tacchino R, Greco F, Matera D. Single-incision laparoscopic cholecystectomy: surgery without a visible scar. Surg Endosc 2009;23:896–9

6. Vidal O, Valentini M, Espert JJ, et al. Laparoendoscopic single-site cholecystectomy: a safe and reproducible alternative. J Laparoendosc Adv Surg Tech A 2009;19:599–602

7. Inoue H, Takeshita K, Endo M. Single-port laparoscopy assisted appendectomy under local pneumoperitoneum condition. Surg Endosc 1994;8:714–16

8. Rao MM, Rao RK. Two-port and single port laparoscopic appendicectomy. J Indian Med Assoc 2004;102:360, 362, 364

9. Ate_ O, Hakgüder G, Olguner M, Akgür FM. Single-port laparoscopic appendectomy conducted intracorporeally with the aid of a transabdominal sling suture. J Pediatr Surg 2007;42:1071–4

10. Vidal O, Valentini M, Ginestà C, et al. Laparoendoscopic single-site surgery appendectomy. Surg Endosc 2010;24:686–91

11. Fader AN, Escobar PF. Laparoendoscopic single-site surgery (LESS) in gynecologic oncology: Technique and initial report. Gynecol Oncol 2009:114;157–61

12. Jacob BP, Tong W, Reiner M, et al. Single incision total extraperitoneal (one SITE) laparoscopic inguinal hernia repair using a single access port device. Hernia 2009;13:571–2

13. Kroh M, Rosenblatt S. Single-port, laparoscopic cholecystectomy and inguinal hernia repair: first clinical report of a new device. J Laparoendosc Adv Surg Tech A 2009;19:215–17

14. Jung YW, Kim SW, Kim YT. Recent advances of robotic surgery and single port laparoscopy in gynecologic oncology. J Gynecol Oncol 2009;20:137–44

15. Hirano D,Minei S, Yamaguchi K, et al. Retroperitoneoscopic adrenalectomy for adrenal tumors via a single large port. J Endourol 2005;19:788–92

16. Bucher P, Pugin F, Morel P. Single port access laparoscopic right hemicolectomy. Int J Colorectal Dis 2008;23:1013–16

17. Tacchino RM, Greco F, Matera D. Laparoscopic gastric banding without visible scar: a short series with intraumbilical SILS. Obes Surg 2010;20:236–9

18. Huang CK, Houng JY, Chiang CJ, et al. Single incision transumbilical laparoscopic Roux-en-Y gastric bypass: A first case report. Obes Surg 2009;19:1711–15

19. Desai MM, Rao PP, Aron M, et al. Scarless single port transumbilical nephrectomy and pyeloplasty: first clinical report. BJU Int 2008:101;83–8

20. Raman JD, Cadeddu JA. Single access laparoscopic nephrectomy. Indian J Urol 2008;24:457–60

21. Rané A, Rao P, Rao P. Single-port-access nephrectomy and other laparoscopic urologic procedures using a novel laparoscopic port (R-port). Urology 2008;72:260–3

22. Stolzenburg JU, Hellawell G, Kallidonis P, et al. Laparoendoscopic single-site surgery: early experience with tumor nephrectomy. J Endourol 2009;23:1287–92

23. Sotelo RJ, Astigueta JC, Desai MM, et al. Laparoendoscopic single-site surgery simple prostatectomy: initial report. Urology 2009;74:626–30

24. Saber AA, Elgamal MH, Itawi EA, Rao AJ. Single incision laparoscopic sleeve gastrectomy (SILS): a novel technique. Obes Surg 2008;18:1338–42

25. Gonzalez JJ Jr. Sleeve gastrectomy and the SILS™ procedure: the Texas Endosurgery Institute experience. Bariatric Times 2009;(Suppl. 2):6–7

26. Barbaros U, Dinçça_ A. Single incision laparoscopic splenectomy: the first two cases. J Gastrointest Surg 2009;13:1520–3

27. NHS Supply Chain. NHS Supply Chain leads the way for innovation [press release]. 9 November 2009. http://www.supplychain.nhs.uk/portal/pls/portal/!PORTAL.wwpob_page.show?_docname=5350629.PDF. Accessed 18 February 2010

COVIDIEN, COVIDIEN with logo, Covidien logo and “positive results for life” are internationally registered trademarks of

Covidien AG. ™marked brands are trademarks of a Covidien company. © 2010 Covidien – M100521/GB – 06/2010