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Injectable BioPulmonic

MitroFix

Annulus Diameter

Model Number NRIP-00015 NRIP-00016 NRIP-00017 NRIP-00019 NRIP-00023 NRIP-00025 NRIP-00027 NRIP-00029 NRIP-00031

Valve Size (mm) 15 16 17 19 23 25 27 29 31

Annulus Diameter

Model Number NRMF-00028 NRMF-00030 NRMF-00032 NRMF-00034 NRMF-00036 NRMF-00038

Valve Size (mm) 28 30 32 34 36 38

Injectable BioPulmonic Trocar

MitroFix Sizer Kit

Model Number BIT-00-15 BIT-00-16 BIT-17-19 BIT-21-25 BIT-27-31

Trocar Size (mm) 10 11 12 13 15

Compatible Valve Sizes (mm) 15 16 17-19 23-25 27-31

Model Number NRMF-SK028 NRMF-SK030 NRMF-SK032 NRMF-SK034 NRMF-SK036 NRMF-SK038

Size(mm) 28 30 32 34 36 38

CARDIAC PORTFOLIO

Patch

BioMitral/BioAortic

Model Number NRPP-3x3 NRPP-5x5 NRPP-6x10 NRPP-8x14 NRPP-11m09 NRPP-13m11 NRPP-15m12

Size (cm) 3x3 5x5 6x10 8x14 11mm diameter 13mm diameter 15mm diameter

BIOMITRAL BIOAORTICAnnulus Diameter

INJECTABLE BIOPULMONIC

Model Number Aortic NRA-00021 NRA-00023 NRA-00025 NRA-00027 Mitral NRM-00027 NRM-00029 NRM-00031 NRM-00033

Valve Size (mm) 21 23 25 27 27 29 31 33

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 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

MITROFIX

PATCH

See your local representative for ordering

0473

No compromise . . .BioIntegral Surgical manufactures cardiac andvascular 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 Demonstrated to reduce adhesions4 and offer high biocompatibility2 High tensile and pull strength7

Porcine Patch

PATCH

Supple, easy to handle and suture

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

Reducing reinfection risk is one of the valvesmajor 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 offthe-shelf solutions can help minimize patient-prosthesis mismatch. Shown to reduce reinfection1 No-React tissue has demonstrated promotion of endothelium6

The No-React treatment. BioIntegral Surgicalmanufactures 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:

Replacement Valve

BIOMITRAL BIOAORTIC

No reports of degradation or failure over 12 years

NO-REACT

Nr

reduced toxicity, enhanced biocompatibiltyMITROFIX

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 durabilityMitral Valve Restoration System

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

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

BioMitral/BioAortic

NO-REACTAnnulus Diameter

Nr

Model Number Aortic NRA-00021 NRA-00023 NRA-00025 NRA-00027 Mitral NRM-00027 NRM-00029 NRM-00031 NRM-00033

Valve Size (mm) 21 23 25 27

27 29 31 33

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.

BIOMITRAL BIOAORTICSTENTED PORCINE AORTIC AND MITRAL BIOPROSTHESES

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

0473

No compromise . . .The all-biological stented porcine valveThe 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 dont require special techniques or instruments, and no pre-operative rinsing is required.

Reducing reinfection risk is one of thevalves 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 and allow the surgeon to intervene more quickly.

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

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:

The No-React treatment.

Endocarditis Protection, Solid Hemodynamics Lowest endocarditis reinfection rate of any off-the-

NO-REACT

Nr

shelf solution1,6 Clinically associated with very good hemodyamics

reduced toxicity, enhanced biocompatibilty lower rates of infection, adhesion, and calcification

and favorable outcomes6 Valves have tested positive for endothelial

the promotion of endothelial lining

1-5

coverage7

No-React Injectable BioPulmonic

Annulus Diameter

Model Number NRIP-00015 NRIP-00016 NRIP-00017 NRIP-00019 NRIP-00023 NRIP-00025 NRIP-00027 NRIP-00029 NRIP-00031

Valve Size (mm) 15 16 17 19 23 25 27 29 31

NO-REACT

Nr

Injectable BioPulmonic Trocar

Please contact your BioIntegral Surgical representative for ordering information

REFERENCES 1 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) 536543. 7 Amir Aboholda, et al. No-React Detoxification Process: A Superior Anticalcification Method for Bioprostheses, An