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CARDIAC PORTFOLIO

INJECTABLE BIOPULMONIC™

INJECTABLEBIOMITRAL™

BIOAORTIC™BIOMITRAL™

PATCHPATCHMITROFIX™

Injectable BioPulmonic™ Trocar

Model Number Trocar Size (mm) Compatible Valve Sizes (mm) BIT-00-15 10 15 BIT-00-16 11 16 BIT-17-19 12 17-19 BIT-21-25 13 23-25 BIT-27-31 15 27-31

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Injectable BioPulmonic™

Model Number Valve Size (mm) NRIP-00015 15 NRIP-00016 16 NRIP-00017 17 NRIP-00019 19 NRIP-00023 23 NRIP-00025 25 NRIP-00027 27 NRIP-00029 29 NRIP-00031 31

Annulus Diameter

Annulus Diameter

Model Number Valve Size (mm)Aortic NRA-00021 21 NRA-00023 23 NRA-00025 25 NRA-00027 27Mitral NRM-00027 27 NRM-00029 29 NRM-00031 31 NRM-00033 33

BioMitral™/BioAortic™

Annulus Diameter

Model Number Valve Size (mm)NRMF-00028 28NRMF-00030 30NRMF-00032 32NRMF-00034 34NRMF-00036 36NRMF-00038 38

MitroFix™

Model Number Size (cm) NRPP-3x3 3x3 NRPP-5x5 5x5 NRPP-6x10 6x10 NRPP-8x14 8x14

NRPP-11m09 11mm diameter NRPP-13m11 13mm diameter NRPP-15m12 15mm diameter

Patch

MitroFix™ Sizer Kit

Model Number Size(mm) NRMF-SK028 28 NRMF-SK030 30 NRMF-SK032 32 NRMF-SK034 34 NRMF-SK036 36 NRMF-SK038 38

REFERENCES1 Michele Musci, et al. “Surgical therapy in patients with active infective endocarditis: seven-year single centre experience in a subgroup of 255 patients treated with the Shelhigh stentless bioprosthesis,” European Journal of Cardiothoracic Surgery 34 (2008) 410-417. 2 Amir Aboholda, et al. “No-React Detoxification Process: A Superior Anticalcification Method for Bioprostheses.” Ann. Thor. Surg. 1996;62:1724-30.3 Victor O. Morell and Peter A. Wearden, “Experience With Bovine Pericardium for the Reconstruction of the Aortic Arch in Patients Undergoing a Norwood Procedure,” Ann Thorac Surg 84, no. 4 (October 1, 2007): 1312-1315.4 Pelosi, MA II, Pelosi MA III. “A new nonabsorbable adhesion barrier for myomectomy,” Am J Surg. 2002 Nov;184(5):428-32.5 Dohmen et al., “Endothelial Cell-Seeded Bovine Internal Mammary Artery for Complete Revascularization,” Ann Thorac Surg 83, no. 3 (March 1, 2007): 1168-1169.6 Mishra PK, Sharma AD, Smallwood KG, Spyt TJ, “A new approach to the treatment of mitral valve prolapse using the MitroFast valvular stenting device,” Heart, 2009 May; 95(5):384.7 Bench testing data, on file.

CAUTION: Refer to the Instructions For Use provided with each device for complete information regarding indications for use, contraindications, warnings and precautions and potential complications.©2009 BioIntegral Surgical, Inc. All rights reserved. www.biointegral-surgical.com

See your local representative for ordering

No compromise . . .

The design philosophy is to solve structural heart issues by minimizing or eliminating compromises to the patient or surgeon. More consistent, simplified, and repeatable operative outcomes help improve morbidity and mortality.

BioIntegral Surgical manufactures cardiac and vascular implants made from all-biological materials. Both the products and No-React® detoxification process were engineered to enhance durability, ease of implantation, and biocompatibility. In addition, the device portfolio aims to treat widest range of patient populations without requiring sophisticated patient selection, repair techniques, or imaging.

THE CARDIAC PRODUCT PORTFOLIO


INJECTABLE

Pulmonic Valve

▶ Large-diameter hybrid percutaneous implantation; no bypass necessary

▶ A full range of sizes is available to match patient morphology

▶ No reported structural failures or stent fracture over 5 years

NrNrNO-REACT

™

The No-React® treatment. BioIntegral Surgical manufactures devices using the No-React® treatment. No-React® is a proprietary detoxification of glutaraldehyde-treated tissue.

12 years of clinical experience with No-React® devices show:

▶ reduced toxicity, enhanced biocompatibilty

▶ lower rates of infection, adhesion, and calcification▶ the promotion of endothelial lining1-5

Reducing reinfection risk is one of the valves’ major benefits. In studies conducted over a seven year time period, No-React® treated valves have demonstrated reinfection rates similar to that of homografts1. Available in all sizes, these off-the-shelf solutions can help minimize patient-prosthesis mismatch.

▶ Demonstrated to reduce adhesions4 and offer high biocompatibility2

▶ High tensile and pull strength7

▶ Supple, easy to handle and suturePATCHPorcine PatchPATCH

▶ Shown to reduce reinfection1

▶ No-React® tissue has demonstrated promotion of endothelium6

▶ No reports of degradation or failure over 12 yearsBIOMITRAL™

BIOAORTIC™

Replacement Valve

BIOMITRAL™

▶ Inspired by the natural anatomy of a posterior mitral valve leaflet in the closed position. An effective tool to promote simplified, reproducible results6

▶ No moving parts: increases durability

▶ Functional sizing with no need for complex resecting of the mitral apparatus which can save time versus conventional repair or replacement

MITROFIX™

Mitral Valve Restoration System

MITROFIX™

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CAUTION: Refer to the Instructions For Use provided with each device for complete information regarding indica-tions for use, contraindications, warnings and precautions and potential complications.

©2009 BioIntegral Surgical, Inc. All rights reserved.www.biointegral-surgical.com

Annulus Diameter

Model Number Valve Size (mm) Aortic NRA-00021 21 NRA-00023 23 NRA-00025 25 NRA-00027 27

Mitral NRM-00027 27 NRM-00029 29 NRM-00031 31 NRM-00033 33

BioMitral™/BioAortic™

REFERENCES

1 Michele Musci, et al. “Surgical therapy in patients with active infective endocarditis: seven-year single centre experience in a subgroup of 255 patients treated with the Shelhigh stentless bioprosthesis,” European Journal of Cardiothoracic Surgery 34 (2008) 410-417. 2 Amir Aboholda, et al. “No-React Detoxification Process: A Superior Anticalcification Method for Bioprostheses.” Ann. Thor. Surg. 1996;62:1724-30.3 Victor O. Morell and Peter A. Wearden, “Experience With Bovine Pericardium for the Reconstruction of the Aortic Arch in Patients Undergoing a Norwood Procedure,” Ann Thorac Surg 84, no. 4 (October 1, 2007): 1312-1315.4 Pelosi, MA II, Pelosi MA III. “A new nonabsorbable adhesion barrier for myomectomy,” Am J Surg. 2002 Nov;184(5):428-32.5 Dohmen et al., “Endothelial Cell-Seeded Bovine Internal Mammary Artery for Complete Revascularization,” Ann Thorac Surg 83, no. 3 (March 1, 2007): 1168-1169.6 Siniawski H, Grauhan O, et al. "Factors Influencing the Results of Double-Valve Surgery in Patients with Fulminant Endocarditis: The Importance of Valve Selection," The Heart Surgery Forum #2004-1075-67(5), 2004.7 Endothelium confirmed using Factor VIII assay.

NrNO-REACT

™

STENTED PORCINE AORTIC AND MITRAL BIOPROSTHESES

BIOMITRAL™

BIOAORTIC™

No compromise . . .The all-biological stented porcine valve

The BioIntegral Surgical No-React® treated BioMitral™ and

BioAortic™ valves are the first replacement valves which avoid

the use of fabric materials. These stented porcine valves don’t

require special techniques or instruments, and no pre-operative

rinsing is required.

Durable: 12 years and counting

▶ Aortic and mitral valves have been in clinical use for 12 years

▶ No reports of stent fracture or tissue failure

Endocarditis Protection, Solid Hemodynamics

▶ Lowest endocarditis reinfection rate of any off-the- shelf solution1,6

▶ Clinically associated with very good hemodyamics and favorable outcomes6

▶ Valves have tested positive for endothelial coverage7

NrNrNO-REACT

™




▶ lower rates of infection, adhesion, and calcification

▶ the promotion of endothelial lining1-5

Reducing reinfection risk is one of the valves’ major benefits. In studies conducted over a seven year time period, No-React® treated valves have demonstrated reinfection rates similar to that of homografts1. Available in all sizes, these off-the-shelf solutions can help minimize patient-prosthesis mis-match and allow the surgeon to intervene more quickly.

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Injectable BioPulmonic™ Trocar

Please contact your BioIntegral Surgical representativefor ordering information

No-React® Injectable BioPulmonic™

Model Number Valve Size (mm) NRIP-00015 15 NRIP-00016 16 NRIP-00017 17 NRIP-00019 19 NRIP-00023 23 NRIP-00025 25 NRIP-00027 27 NRIP-00029 29 NRIP-00031 31

Annulus Diameter

REFERENCES1 Schrieber, et al. "Implantation of a Prosthesis Mounted Inside a Self-Expandable Stent in the Pulmonary Valvar Area Without Use of Cardiopulmonary Bypass", Ann Thorac Surg 2006;81:e1-3.2 Marianeschi, et al. "Pulmonary Valve Implantation with the New Shelhigh Injectable Stented Pulmonic Valve", Ann Thorac Surg 2008;86:1466 –72.3 Berdat P, et al. "Off-pump pulmonary valve replacement with the New Shelhigh Injectable Stented Pulmonic Valve", J Cardiovasc Surg 2006;131:1192-3.4 Ustunsoy H, et al. "Off-Pump Pulmonary Valve Implantation", J Cardiac Surg 2008.5 Dittrich, S., et al. "Hybrid Pulmonary Valve Implantation: Injection of a Self-Expanding Tissue Valve Through the Main Pulmonary Artery", Ann Thorac Surg 2008;85:632-4.6 Coats L, Tsang V, et al. "Potential impact of percutaneous pulmonary valve stent implantation on RVOT re-intervention", European Journal of Cardio-thoracic Surgery 27 (2005) 536–543.7 Amir Aboholda, et al. “No-React Detoxification Process: A Superior Anticalcification Method for Bioprostheses”, Ann. Thor. Surg. 1996;62:1724-30.8 Victor O. Morell and Peter A. Wearden. “Experience With Bovine Pericardium for the Reconstruction of the Aortic Arch in Patients Undergoing a Norwood Procedure”, Ann Thorac Surg 84, no. 4 (October 1, 2007): 1312-1315.9 Michele Musci, et al. “Surgical therapy in patients with active infective endocarditis: seven-year single centre experience in a subgroup of 255 patients treated with the Shelhigh stentless bioprosthesis”, European Journal of Cardiothoracic Surgery 34 (2008) 410-417. 10 Pelosi, MA II, Pelosi MA III. “A new nonabsorbable adhesion barrier for myomectomy”, Am J Surg. 2002 Nov;184(5):428-32.11 Dohmen et al., “Endothelial Cell-Seeded Bovine Internal Mammary Artery for Complete Revascularization”, Ann Thorac Surg 83, no. 3 (March 1, 2007): 1168-1169.12 Armillotta A, Bonhoeffer P, et al. "Use of rapid prototyping models in the planning of percutaneous pulmonary valved stent implantation", Proc Inst Mech Eng H. 2007 May;221(4):407-16.13 Schievano S, et al. "Variations in Right Ventricular Outflow Tract Morphology Following Repair of Congenital Heart Disease: Implications for Percutaneous Pulmonary Valve Implantation", J Cardiovasc Magn Reson. 2007;9(4):687-95.

CAUTION: Refer to the Instructions For Use provided with each device for complete information regarding indications for use, contraindications, warnings and precautions and potential complications.

©2009 BioIntegral Surgical, Inc. All rights reservedwww.biointegral-surgical.com

NrNrNO-REACT

™

OFF - PUMP INJECTABLE PORCINE PULMONIC BIOPROSTHESIS


A Hybrid Percutaneous Approach

▶ Large-diameter trocar methods offer direct implantation versus more limited interventional techniques

▶ No size limitations

▶ No complex imaging required12

TrocarBarrel

Introducer

No compromise . . .The Self-Expanding No-React® Injectable BioPulmonic A percutaneous, large diameter injectable valve implanted without cardio-pulmonary bypass.

Cardiopulmonary bypass is out, large sizes are inThis off-pump device has been shown effective in treating PVR in patients suffering from congenital heart disease1-4. While other percutaneous options are limited to 22 mm, the NRIP is available in a complete range of sizes from 15 - 31 mm5.

Durable: 5 years and counting▶ 5 years experience, longest of any minimally invasive pulmonic

▶ External fixation prevents migration

▶ No stent fracture reported

Deliver any size.

NrNrNO-REACT

™

The No-React® treatment. BioIntegral Surgical manufactures devices using the No-React® treatment. No-React® is a propri-etary detoxification of glutaraldehyde-treated tissue.





100% = All patients with RVOT insufficiency

0%

20%

40%

60%

80%

100%

Eligible patients with the BioIntegral BioPulmonic

Eligible patients for alternative percutaneous valve

Treat more patients13

Annulus Diameter

Model Number Valve Size (mm)

NRMF-00028 28 NRMF-00030 30 NRMF-00032 32 NRMF-00034 34 NRMF-00036 36 NRMF-00038 38

MitroFix™ Device

CAUTION: Refer to the Instructions For Use provided with each device for complete information regarding indica-tions for use, contraindications, warnings, precautions, and potential complications.©2009 BioIntegral Surgical, Inc. All rights reserved.www.biointegral-surgical.com

REFERENCES

1 Average EOA from 2.8 to 3.2 cm2 observed in various clinical experience with the MitroFix device compares favorably to 2.0 cm2 range seen frequently with mechanical mitral valves.2 Amir Aboholda, et al. “No-React Detoxification Process: A Superior Anticalcification Method for Bioprostheses.” Ann. Thor. Surg. 1996;62:1724-30.3 Victor O. Morell and Peter A. Wearden, “Experience With Bovine Pericardium for the Reconstruction of the Aortic Arch in Patients Undergoing a Norwood Procedure,” Ann Thorac Surg 84, no. 4 (October 1, 2007): 1312-1315.4 Michele Musci, et al. “Surgical therapy in patients with active infective endocarditis: seven-year single centre experience in a subgroup of 255 patients treated with the Shelhigh stentless bioprosthesis,” European Journal of Cardiothoracic Surgery 34 (2008) 410-417. 5 Pelosi, MA II, Pelosi MA III. “A new nonabsorbable adhesion barrier for myomectomy,” Am J Surg. 2002 Nov;184(5):428-32.6 Dohmen et al., “Endothelial Cell-Seeded Bovine Internal Mammary Artery for Complete Revascularization,” Ann Thorac Surg 83, no. 3 (March 1, 2007): 1168-1169.7 Mishra PK, Sharma AD, Smallwood KG, Spyt TJ, “A new approach to the treatment of mitral valve prolapse using the MitroFast valvular stenting device,” Heart, 2009 May; 95(5):384.8 Oertel, et al., “Possible Indications for the MitroFast,” Presented at the 18th WSCTS World Congress, April 30th - May 3, 2008. Kos, Greece.9 Clinical communications, data on file.


Model Number Size(mm)

NRMF-SK028 28 NRMF-SK030 30 NRMF-SK032 32 NRMF-SK034 34 NRMF-SK036 36 NRMF-SK038 38

0473See your local representative for ordering

NrNrNO-REACT

™

MITRAL VALVE RESTORATION SYSTEM

MITROFIX™

MITROFIX™MITROFIX™ SIZERROFIX™ S MITROFIX™

NrNrNO-REACT

™

Restoration Goes Beyond Repair: MitroFix™ is a system, not just a device

▶ Test before you commit: a functional sizer demonstrates the likely outcome of the restoration before full commitment is made

▶ An effective tool for promotes simplified, reproducible results7

▶ The system’s goal is to maximize EOA, not to constrict or undersize

▶ No need to compensate for tethering8

n

Implanted BioIntegral MitroFix™ with open anterior leaflet (A) and closed anterior leaflet (B)

A

B

No compromise . . .The No-React® MitroFix™ Restoration SystemA system inspired by emulating the naturally closed posterior mitral leaflet in order to maximize the anterior leaflet's optimal function. The device is combined with a functional sizer to test coaptation and save surgical time, while retaining the clinical benefits of using the patient’s own valve.

Turn the art of repair into the science of restorationThe MitroFix™ system allows a surgeon to quickly and easily create a monoleaflet valve - the goal of current repair techniques. Instead of restricting the mitral annulus with traditional annuloplasty, you can now maximize it. The MitroFix™ has shown to deliver a greater EOA than expected with repair or replacement1.

Durable: 5 years and counting▶ 5 years human clinical experience▶ A pliable stent covered in No-React®-treated porcine pericardium duplicates the natural closed posterior leaflet▶ No erosion of the device or the anterior leaflet has been reported

Clinical experience indicates that approximately 25% of cases which are beyond repair and would require replacement can be restored with the MitroFix8.

▶ Ischemic

▶ Destruction or infection of the posterior leaflet

▶ Complex etiology where repair is impossible or not feasible

Major IndicationsRestore in cases where repair is impossible

NrNrNO-REACT

™

The No-React® treatment. BioIntegral Surgical manufactures devices using the No-React® treatment. No-React® is a proprietary detoxifcation of glutaraldehyde-treated tissue.





Experience indicates markedly reduced cross-clamp times compared with repair or replacement alternatives9. If performing complex repairs or multiple procedures, the MitroFix™ should be part of your armamentarium.

Save time when essential for outcome/survival

Annulus Diameter

Model Number Valve Size (mm)

NRMF-00028 28 NRMF-00030 30 NRMF-00032 32 NRMF-00034 34 NRMF-00036 36 NRMF-00038 38

MitroFix™ Device

CAUTION: Refer to the Instructions For Use provided with each device for complete information regarding indica-tions for use, contraindications, warnings, precautions, and potential complications.©2009 BioIntegral Surgical, Inc. All rights reserved.www.biointegral-surgical.com

REFERENCES

1 Average EOA from 2.8 to 3.2 cm2 observed in various clinical experience with the MitroFix device compares favorably to 2.0 cm2 range seen frequently with mechanical mitral valves.2 Amir Aboholda, et al. “No-React Detoxification Process: A Superior Anticalcification Method for Bioprostheses.” Ann. Thor. Surg. 1996;62:1724-30.3 Victor O. Morell and Peter A. Wearden, “Experience With Bovine Pericardium for the Reconstruction of the Aortic Arch in Patients Undergoing a Norwood Procedure,” Ann Thorac Surg 84, no. 4 (October 1, 2007): 1312-1315.4 Michele Musci, et al. “Surgical therapy in patients with active infective endocarditis: seven-year single centre experience in a subgroup of 255 patients treated with the Shelhigh stentless bioprosthesis,” European Journal of Cardiothoracic Surgery 34 (2008) 410-417. 5 Pelosi, MA II, Pelosi MA III. “A new nonabsorbable adhesion barrier for myomectomy,” Am J Surg. 2002 Nov;184(5):428-32.6 Dohmen et al., “Endothelial Cell-Seeded Bovine Internal Mammary Artery for Complete Revascularization,” Ann Thorac Surg 83, no. 3 (March 1, 2007): 1168-1169.7 Mishra PK, Sharma AD, Smallwood KG, Spyt TJ, “A new approach to the treatment of mitral valve prolapse using the MitroFast valvular stenting device,” Heart, 2009 May; 95(5):384.8 Oertel, et al., “Possible Indications for the MitroFast,” Presented at the 18th WSCTS World Congress, April 30th - May 3, 2008. Kos, Greece.9 Clinical communications, data on file.


Model Number Size(mm)

NRMF-SK028 28 NRMF-SK030 30 NRMF-SK032 32 NRMF-SK034 34 NRMF-SK036 36 NRMF-SK038 38

0473See your local representative for ordering

NrNrNO-REACT

™

MITRAL VALVE RESTORATION SYSTEM

MITROFIX™

MITROFIX™MITROFIX™ SIZERROFIX™ S MITROFIX™

NrNO-REACT

™

ULTRAFLEXBILE , STENTED PORCINE AORTIC BIOPROSTHESES

VERSAFLEX™

0473

CAUTION: Refer to the Instructions For Use provided with each device for complete information regarding indica-tions for use, contraindications, warnings and precautions and potential complications.

©2009 BioIntegral Surgical, Inc. All rights reserved.www.biointegral-surgical.com

Annulus Diameter

Model Number Valve Size (mm) NRV-00021 21 NRV-00023 23 NRV-00025 25 NRV-00027 27

Versaflex™

REFERENCES

1 Michele Musci, et al. “Surgical therapy in patients with active infective endocarditis: seven-year single centre experience in a subgroup of 255 patients treated with the Shelhigh stentless bioprosthesis,” European Journal of Cardiothoracic Surgery 34 (2008) 410-417. 2 Amir Aboholda, et al. “No-React Detoxification Process: A Superior Anticalcification Method for Bioprostheses.” Ann. Thor. Surg. 1996;62:1724-30.3 Victor O. Morell and Peter A. Wearden, “Experience With Bovine Pericardium for the Reconstruction of the Aortic Arch in Patients Undergoing a Norwood Procedure,” Ann Thorac Surg 84, no. 4 (October 1, 2007): 1312-1315.4 Pelosi, MA II, Pelosi MA III. “A new nonabsorbable adhesion barrier for myomectomy,” Am J Surg. 2002 Nov;184(5):428-32.5 Dohmen et al., “Endothelial Cell-Seeded Bovine Internal Mammary Artery for Complete Revascularization,” Ann Thorac Surg 83, no. 3 (March 1, 2007): 1168-1169.6 Germing A, et al. “Patient-prosthesis mismatch and left ventricular remodelling after implantation of Shelhigh SuperStentless aortic valve prostheses.” Cardiovasc Surg (Torino). 2008 Aug;49(4):539-43.7 Cattaneo et al., 2007, European Journal of Cardio-thoracic Surgery, "Early hemodynamic results of the Shelhigh SuperStentless aortic bioprosthesis”. J Card Surg 2007;22:379-384.8 Siniawski H, Grauhan O, et al. "Factors Influencing the Results of Double-Valve Surgery in Patients with Fulminant Endocarditis: The Importance of Valve Selection," The Heart Surgery Forum #2004-1075-67(5), 2004.9 Endothelium confirmed using Factor VIII assay.

NrNrNO-REACT

™

Restoration Goes Beyond Repair: MitroFix™ is a system, not just a device

▶ Test before you commit: a functional sizer demonstrates the likely outcome of the restoration before full commitment is made

▶ An effective tool for promotes simplified, reproducible results7

▶ The system’s goal is to maximize EOA, not to constrict or undersize

▶ No need to compensate for tethering8

n

Implanted BioIntegral MitroFix™ with open anterior leaflet (A) and closed anterior leaflet (B)

A

B

Clinical experience indicates that approximately 25% of cases which are beyond repair and would require replacement can be restored with the MitroFix8.

▶ Ischemic

▶ Destruction or infection of the posterior leaflet

▶ Complex etiology where repair is impossible or not feasible

Major IndicationsRestore in cases where repair is impossible

NrExperience indicates markedly reduced cross-clamp times compared with repair or replacement alternatives9. If performing complex repairs or multiple procedures, the MitroFix™ should be part of your armamentarium.

Save time when essential for outcome/survival

No compromise . . .Utlimate versatility in an aortic valveThe BioIntegral Surgical No-React® treated Versaflex™ valve was

designed for ultimate versatility. Its wide clinical applicability is

equal to a stented valve, while it delivers the hemodynamics of a

stentless valve. The Versaflex doesn’t require special tech-

niques or instruments, and no pre-operative rinsing is required.

Designed for durability, hemodynamics▶ Over 12 years of clinical use and follow-up, no reports of

stent fracture or tissue failure

▶ Pledgeted commissures distribute stresses of valve closure

▶ Flexible stent delivers good hemodynamics, but avoids

distortion common to stentless valves

NrNO-REACT

™






The Versaflex Delivers the Best of What Stent-less AND Stented Valves Offer Without the Dis-advantages

▶ As easy to implant as a stented valve

▶ Super-flexible stent allows for less reliance on the

shape of the annulus for proper fit. Aortic root

asymmetry has no influence on result

▶ Oversizing possible with full benefits

▶ High clinical applicability: suitable for any patient6

▶ Clinically associated with very good hemodyamics

and favorable outcomes, including signifi cant

increase in EOA and reduction in left ventricular

mass6,7

▶ Valves have tested positive for endothelial

coverage8,9, and the valves have been used to avoid

reinfection in cases of infective endocarditis

Even distorted wider by 2-3 sizes, the

valve can still coaptNrNrNO-REACT

™

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REFERENCES

1 Pelosi, MA II, Pelosi MA III. “A new nonabsorbable adhesion barrier for myomectomy”, Am J Surg. 2002 Nov;184(5):428-32.2 Amir Aboholda, et al. “No-React Detoxification Process: A Superior Anticalcification Method for Bioprostheses”, Ann. Thor. Surg. 1996;62:1724-30.3 Victor O. Morell and Peter A. Wearden. “Experience With Bovine Pericardium for the Reconstruc- tion of the Aortic Arch in Patients Undergoing a Norwood Procedure”, Ann Thorac Surg 84, no. 4 (October 1, 2007): 1312-1315.4 Bench testing, data on file.5 Michele Musci, et al. “Surgical therapy in patients with active infective endocarditis: seven-year single centre experience in a subgroup of 255 patients treated with the Shelhigh stentless biopros thesis”, European Journal of Cardiothoracic Surgery 34 (2008) 410-417. 6 Dohmen et al., “Endothelial Cell-Seeded Bovine Internal Mammary Artery for Complete Revascular- ization”, Ann Thorac Surg 83, no. 3 (March 1, 2007): 1168-1169.

* Patches come in lengths of 9 to 12 centimeters minimum lengths.

CAUTION: Refer to the Instructions For Use provided with each device for complete information regarding indications for use, contraindications, warnings, precautions and potential complications.

©2009 BioIntegral Surgical, Inc. All rights reserved. www.biointegral-surgical.com

See your local representative for ordering

PATCHPATCH

Model Number Size (cm/mm) NRPP-03x03 3x3 cm NRPP-05x05 5x5 NRPP-06x10 6x10 NRPP-08x14 8x14

NRPP-11m09 11 mm diameter* NRPP-13m11 13 diameter NRPP-15m12 15 diameter

Patch

Porcine Pericardial Patch▶ Demonstrated to reduce adhesions1

and offer high biocompatibility2,3

▶ Supple, easy to handle

▶ Good suture reapproximation,

reduced need for hemostatic agents

▶ No reports of calcification

▶ High tensile and pull strength4

▶ 12 years of clinical experience

NrNrNO-REACT

™






No compromise . . .

NrNrNO-REACT

™

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