VALUE ANALYSIS COMMITTEE PRODUCT INFORMATION KIT. Symbotex Composite Mesh for ventral hernia repair

Transcription

1 VALUE ANALYSIS COMMITTEE PRODUCT INFORMATION KIT Symbotex Composite Mesh for ventral hernia repair

2 For meeting ventral hernia repair needs, Symbotex composite mesh gives surgeons improved ease of use and optimized performance to minimize visceral tissue attachments.

3 TABLE OF CONTENTS Product Overview...4 Product Introduction... 4 Features and Benefits... 5 Product Diagram...7 Product Specifications (k) Clearance...8 Technical Data Overview Preclinical Data Value Proposition Preclinical Results Reimbursement Competitive Information Competitive Products Overview Material Management Information

4 PRODUCT OVERVIEW Product introduction As the market leader in hernia repair, we continue to set new standards in quality, ease of use, and value. Drawing on 20 years of cutting-edge biomedical engineering, our mastery of balanced mesh mechanical properties is matched by our understanding of what best serves the needs of surgeons, patients, and hospitals. Our portfolio of innovative hernia products includes ProGrip laparoscopic self-fixating mesh, ReliaTack Articulating Reloadable Fixation Device, and the Spacemaker Pro Access and Dissector System. These products are expanding the frontiers of what s possible in hernia repair. At the same time, we remain responsive to the needs of hospitals for products that deliver consistent high quality at a justifiable price. Why should a hospital purchase Symbotex composite mesh? Surgical Focus Symbotex composite mesh is designed to match the capabilities of Parietex composite and Parietex optimized composite mesh in meeting the surgeon s demands for ease of handling, operative efficiency, versatility, and demonstrated equivalent performance. It provides mesh transparency for improved anatomy visualization, easy mesh deployment, effective clinging for mesh placement, and excellent tissue integration for durable repair. 1-3 Economic Value Proposition We offer a comprehensive portfolio of mesh products for small, medium, and large defects. 4,5 Our versatile products allow standardization of procedures and help optimize efficiency in the hospital. 4

5 Features and benefits Smart Design Innovative mesh features for streamlined performance 3-D mesh structure delivering reinforced Exclusive textile strength and significant tissue ingrowth support6,7 Mesh transparency for improved anatomy visualization during placement1 Established bioabsorbable film technology with impressive resistance to surgical handling4,8 Comprehensive shape and size portfolio for small, medium, and large defects4,5 5

6 Features and benefits Smart Handling Experience simplicity in ventral hernia repair Easy mesh deployment1 Centering and orientation marking for accurate mesh positioning Ω,1,4 Abdominal wall clinging effect for simplified mesh placement,1,9 Smart Repair Designed to offer patients optimized ventral hernia repair performance Excellent tissue integration2 Minimized visceral attachment10 Good level of neoperitonization and better minimizing tissue attachment compared with that of Bard Ventralight * ST mesh,3 Helping to meet physiological needs through balanced mesh mechanical properties 6 Ω If the mesh is not cut, refer to the Instructions for Use Except in cases in which transfascial sutures are used as well as meshes in open approach Four weeks after implantation 6

7 PRODUCT DIAGRAM Pore Size Sterilization Method Shelf Life 3D Textile: 3.3 mm x 2.3 mm 11 Gamma Radiation 11 5 years 12 Product specifications Device Classification Symbotex composite mesh is intended for the reinforcement of abdominal wall soft tissue where a weakness exists, in procedures involving primary abdominal wall and incisional hernia surgeries. Material Composition 3-D textile monofilament polyester (PET), white textile Nonabsorbable monofilament polyester (PET), green textile Bioabsorbable film of collagen and glycerol 7

8 510(K) Clearance 8

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10 510(K) Clearance DEPARTMENT OF HEALTH & HUMAN SERVICES Public Health Service Food and Drug Administration New Hampshire Avenue Document Control Center WO66-G609 Silver Spring, MD November 24, 2014 Sofradim Production Ms. Mary Mellows Senior Regulatory Specialist 60 Middletown Avenue North Haven, Connecticut Re: K Trade/Device Name: Parietex Lightweight Mesh Regulation Number: 21 CFR Regulation Name: Surgical mesh Regulatory Class: Class II Product Code: FTL Dated: October 7, 2014 Received: October 8, 2014 Dear Ms. Mellows: This letter corrects our substantially equivalent letter of November 14, We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you; however, that device labeling must be truthful and not misleading. If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please be advised that FDA s issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must 10

11 Page 2 Ms. Mary Mellows comply with all the Act s requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR [SELECT ONE: Part 801 [or, for IVDs only] Parts 801 and 809] ); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections of the Act); 21 CFR If you desire specific advice for your device on our labeling regulation (21 CFR Part [SELECT ONE: Part 801 [or, for IVDs only] Parts 801 and 809] ), please contact the Division of Industry and Consumer Education at its toll-free number (800) or (301) or at its Internet address Also, please note the regulation entitled, Misbranding by reference to premarket notification (21CFR Part ). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to for the CDRH s Office of Surveillance and Biometrics/Division of Postmarket Surveillance. You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) or (301) or at its Internet address for Sincerely yours, David Krause -S Binita S. Ashar, M.D., M.B.A., F.A.C.S. Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure 11

12 TECHNICAL DATA Overview Symbotex composite mesh was designed to offer patients optimized ventral hernia repair performance. It has a number of versatile properties that make it an appropriate choice for ventral hernia repair. The dual-sided mesh is designed to help optimize tissue integration and minimize visceral attachments. The dual-sided 3-D mesh features: 1 Nonabsorbable 3-D monofilament polyester textile 2 Bioabsorbable hydrophilic film made of porcinebased collagen and glycerol 11 The nonabsorbable textile side is placed against the fascia. It provides excellent tissue integration. 2 The bioabsorbable visceral film side minimizes tissue attachment to the viscera in the event of direct contact by physically separating the polyester textile of the mesh from organs. The 3-D structure of the mesh reinforces textile strength6 and provides significant tissue ingrowth support. 7 Accuracy of placement is facilitated by a dyed monofilament marking (D&C Green No. 6) on the center of the textile that helps the surgeon center and orient the mesh. 1,4,8 Responding to what matters to surgeons, we lead the way in innovative products for hernia repair. 12

13 Clinical data Clinical Literature In 1996, the landmark product Parietex composite mesh was launched. Symbotex composite mesh is an evolution of Parietex composite mesh and Parietex optimized composite mesh with an improved antiadhesion barrier and a monofilament parietal layer with larger pore size. The longevity of our Parietex composite mesh has allowed users to publish a significant amount of human data proving the long-term outcomes of our products. Forty-eight clinical articles accounting for a total of 37 distinct clinical studies have been retrieved and analyzed for Parietex composite mesh. Intraperitoneal treatment of incisional and umbilical hernias using an innovative composite mesh: four-year results of a prospective multicenter clinical trial Balique JG, Benchetrit S, Bouillot JL, et al. Hernia. 2005;9(1): Adhesion Results of a Prospective Multicenter Clinical Study Where Parietex Composite Mesh Was Used The study included 80 patients with mean follow-up of 4 years (range, 3.5 to 4.5). After 12 months, 86% of the patients were ultrasonically adhesion-free. At 48 months, no occlusion, fistula, or mesh sepsis was reported in the long-term follow-up. There was one direct recurrence (1.8%) and six* indirect recurrences (10%). 80 patients, 48 months Polyester-based mesh for ventral hernia repair: is it safe? Rosen MJ. Am J Surg. 2009;197(3): Results of a Retrospective Clinical Study Using Parietex Composite Mesh The study included 109 complex ventral hernia repairs. Polyester mesh provided distinct advantages for ventral hernia repair, with excellent tissue incorporation and minimal shrinkage. In the open repair group, three wound infections (13%) occurred. For patients undergoing laparoscopic repair, there were no delayed mesh infections, fistulas, or hernia recurrences at mean follow-up of 14 months. 109 patients, 14 months Long-term results of laparoscopic repair of incisional hernias using an intraperitoneal composite mesh Moreno-Egea A, Bustos JA, Girela E, et al. Surg Endosc. 2010;24(2): Results of a 12-Year Prospective Clinical Study Using Parietex Composite Mesh The study included 200 patients with mean follow-up of 6 years (range, 1 to 12). Postoperative pain was limited. No mesh infections were detected, including in those who received intestinal injury repair. Eleven recurrences (6.2%) were diagnosed. 200 patients, 6 years Long-term outcomes of 1,326 laparoscopic incisional and ventral hernia repair with the routine suturing concept: a single institution experience. Chelala E. et al. Hernia Feb; 20(1): Results of a Retrospective Study of Visceral Attachments and Recurrence Using Parietex Composite Mesh On a second-look follow-up of 126 patients (9.5%), 45.23% were adhesion free, 42.06% had minor adhesions classified as Muller I, and 12.69% had serosal adhesions classified as Muller II. In second-look patients, the authors observed a well-vascularized neoperitoneum that covered homogeneously the entire mesh and protected its edges against edges. A recurrence rate of 4.72% over the total 1,101 controlled patients. 1,326 patients, 126 secondlook cases, 78 months * Only one necessitated new surgery 13

14 A resorbable collagen barrier limits visceral attachments. Before resorption of the collagen barrier Transversal section 1 week after implantation Abdominal wall Mesh deep thread Collagen barrier Neoformed mesothelial layer Mesh superficial thread Value proposition with preclinical evidence After resorption, a neoperitoneum is formed on the visceral surface. 6 Proven Protection with Collagen Barrier 8,13 In an animal study comparing meshes with and without a protective barrier: Collagen-protected meshes had significantly fewer visceral attachments vs.nonprotected meshes (p < 0.01) Complete recolonization of the mesh and film resorption occurred in the collagen-protected group after 45 days The collagen barrier remained intact after 7 days. Small bowel adhesion was never observed in all groups receiving the composite mesh After resorption of the collagen barrier Transversal section 6 weeks after implantation Intimate attachment of the mesh to the wall Differentiated tissue ingrowth Differentiated tissue ingrowth Abdominal wall Mesh deep thread Mesh superficial thread Based on pre-clinical animal data 14

15 Symbotex composite mesh 4 weeks after implantation in a porcine model Complete tissue integration free from extensive fibrosis and inflammation while fully supporting the wall Preclinical results Tissue Integration and Neoperitonization; Symbotex Composite Mesh vs. Other Products Favorable Tissue Integration vs. Other Meshes 3 Bard Ventralight * mesh: marked inflammation and high level of fibrosis Neoperitoneum Formation 3 Higher level of neoperitoneum formation (at 4 weeks) than Bard Ventralight * mesh Conclusion 3 Symbotex composite mesh helps optimize tissue integration and neoperitoneum formation Based on pre-clinical animal data 15

16 Reimbursement We have developed an online reimbursement resource for hernia and abdominal wall repair. You can reference the interactive U.S. Hernia Reimbursement Guide at medtronic.com/covidien/products/hernia-repair for the most up-to-date codes and reimbursement rates. Procedure Codes ICD-9-CM Code Description Incisional hernia repair Other open incisional hernia repair with graft or prosthesis Laparoscopic incisional hernia repair with graft or prosthesis MS-DRG Description Medicare National Average Payment Rate 353 Hernia procedures except inguinal and femoral with MCC $16, Hernia procedures except inguinal and femoral with CC $9, Hernia procedures except inguinal and femoral without CC/MCC $6,834 Source: CMS inpatient prospective payment system; 2014 final rule, Federal Register, August 13, 2013;78(160):

17 PRODUCT DIAGRAM Instructions COMPETITIVE for use INFORMATION Competitive products overview Medtronic Bard Features Symbotex Composite Mesh Ventralight * ST Mesh Handling properties Clinging effect X Orientation marking X X Macroporous X Transparent X Textile for tissue integration 3-D 3-D Polyester/ polypropylene Polyester Polypropylene Monofilament X X Film for minimized visceral attachment Film Collagen film Hydrogel barrier Resorbable Within one month 30 days Dual-sided mesh X X Internal report: Bard Ventralight * TEX024-a 17

18 Competitive products overview Product/Range Symbotex Composite Mesh Bard Ventralight * ST Composite Mesh Clinging effect X Transparency X Portfolio From 9 cm to 42 x 32 cm From 11.4 to 30.5 x 35.6 cm Visual aid X Structure 3-D macroporous 2-D after absorption, not macroporous Textile PET monofilament PP monofilament and PGA multifilament Film Oxidized collagen and glycerol Sodium hyaluronate (HA), carboxymethylcellulose (CMC), polyethylene glycol (PEG) Internal report: Bard Ventralight * TEX024-a 18

19 PRODUCT DIAGRAM Instructions MATERIAL for use MANAGEMENT INFORMATION Packaging Overview Symbotex composite mesh is available in a wide range of shapes and sizes to accommodate small, medium, and large defects. 8 Ordering information Hernia Products Website: medtronic.com/covidien/products/hernia-repair Ordering code Description Quantity SYM9 Symbotex Composite Mesh/9 cm diameter box of 1 SYM12 Symbotex Composite Mesh/12 cm diameter box of 1 SYM15 Symbotex Composite Mesh/15 cm diameter box of 1 SYM20 Symbotex Composite Mesh/20 cm diameter box of 1 SYM1510 Symbotex Composite Mesh/15 x 10 cm box of 1 SYM2015 Symbotex Composite Mesh/20 x 15 cm box of 1 SYM2520 Symbotex Composite Mesh/25 x 20 cm box of 1 SYM3020 Symbotex Composite Mesh/30 x 20 cm box of 1 SYM3728 Symbotex Composite Mesh/37 x 28 cm box of 1 SYM4232 Symbotex Composite Mesh/42 x 32 cm box of 1 SYM2012E Symbotex Composite Mesh/20 x 12 cm box of 1 SYM1710E Symbotex Composite Mesh/17 x 10 cm box of 1 SYM2515E Symbotex Composite Mesh/25 x 15 cm box of 1 SYM3420E Symbotex Composite Mesh/34 x 20 cm box of 1 SYM4024E Symbotex Composite Mesh/40 x 24 cm box of 1 SYM8OS Symbotex Composite Mesh/8 cm diameter with skirt box of 1 SYM1510OS Symbotex Composite Mesh/15 x 10 cm with skirt box of 1 SYM2015OS Symbotex Composite Mesh/20 x 15 cm with skirt box of 1 SYM2520OS Symbotex Composite Mesh/25 x 20 cm with skirt box of 1 SYM3020OS Symbotex Composite Mesh/30 x 20 cm with skirt box of 1 19

20 HERNIA CARE Mesh. Fixation. Permacol. Dissection. Our comprehensive product portfolio can enhance your hernia repair procedures. Photo credit: Thinkstock References 1. Demonstrated in an internally sponsored preclinical study, report #0901CR252, carried out on pigs in May 2013 with 6 surgeons and aimed at validating the design of Symbotex composite mesh. June Assessed in an internally sponsored preclinical study initiated in May 2013, using a porcine model to evaluate local tissue effects and tissue integration of Symbotex composite mesh vs Parietex optimized composite mesh after laparoscopic ventral repair. NAMSA report # October Evaluated in a preclinical sponsored study conducted in April 2013 comparing local tissue effects and integration, collagen film degradation, and tissue attachment performance of Symbotex composite mesh with Ventralight * ST mesh and Physiomesh * flexible composite mesh in a porcine model. NAMSA report # October Based on results of an internally sponsored preclinical study, design validation report #0901CR249a, carried out on a porcine model to validate the design of Symbotex composite mesh. June Based on internal size and shape comparison chart. 6. Based on internal test report #TEX043, Comparison of the physical and mechanical properties of Symbotex composite mesh to those of Parietex optimized composite mesh. July Cobb W, Lomanto D, Lecuivre J, et al; Hernia Center, Greenville Hospital System University Medical Center. Comparative analysis of the performance of a series of meshes based on weight and pore size in a novel minipig hernia model. Hernia. 2013;17(suppl 1):S Documented in design verification report #0901CR247b. July Based on internal memorandum #0901CR261a, Definition of the Symbotex clinging effect observed during the design validation conducted in May 2013 on a porcine model. July Assessed in an internally sponsored preclinical study initiated in April 2013 using a rat caecal abrasion model and evaluating local tissue effects, tissue integration, and minimizing tissue attachment performance of Symbotex composite mesh vs. Parietex optimized composite mesh. NAMSA report # May Symbotex composite mesh Instructions for Use. 12. Based on internal stability report #RQE036. Based on Internal Stability report #STAB1308RP02. Symbotex Composite Mesh 3 years stability after Gamma sterilization. July Therin M, et al. Preclinical evaluation of a new composite mesh (collagen-polyester) for intraperitoneal hernia repair with the selective property of tissue ingrowth on one side and adhesion prevention on the opposite side. Paper presented at 14th European Conference on Biomaterials; September, 1998; The Hague, The Netherlands. Ω If the mesh is not cut, refer to the Instructions for Use. Except in cases in which transfascial sutures are used as well as meshes in open approach. Four weeks after implantation. Based on pre-clinical animal data Always refer to the Instructions for Use (IFU) for product information, indications and contraindications Medtronic. All rights reserved. Medtronic, Medtronic logo and Further, Together are trademarks of Medtronic. * Third party brands are trademarks of their respective owners. All other brands are trademarks of a Medtronic company. 10/2016 P130056(3) [REF#880651] 555 Long Wharf Drive New Haven, CT medtronic.com/covidien