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SJM Biocor™ Stented Valve System with FlexFit™ Stent

The SJM Biocor Stented Valve System—which includes aortic, mitral, and supra valves—provides the industry's lowest overall implant profile with 20 years of established clinical experience. The valve design of the SJM Biocor Stented Valve System provides easy positioning within the cardiac anatomy.
Overview

Superior Implantability

  • Unique FlexFit Polymer Stent: Adapts easily to the annulus and enhances knot positioning
  • Low Stent Posts: Minimizes aortic wall protrusion and reduces left ventricular outflow tract obstruction in the mitral position
  • Low Stent Base: Provides optimal coronary ostia clearance
  • Suture-Friendly Cuff: Minimizes suture drag and parachuting forces
Biocor Stented Valve implantability

 

Low Stent Posts

Biocor Stented Valve low stent

Tech Specs

Biocor™ Stented Tissue Valve

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Contents: Aortic Stented Tissue Valve (1 unit per box)

Reorder Number Valve Size (mm) Tissue Annulus Diameter (mm) Internal Diameter (mm) Aortic Protrusion (mm) Total Height (mm)
B100-21A-00 21 21 19 9 14
B100-23A-00 23 23 21 9 15
B100-25A-00 25 25 23 10 16
B100-27A-00 27 27 25 11 17
B100-29A-00 29 29 27 12 19

Biocor™ Supra Stented Tissue Valve

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Contents: Aortic Supra-Annular Stented Tissue Valve (1 unit per box)

Reorder Number Valve Size (mm) Tissue Annulus Diameter (mm) Internal Diameter (mm) Aortic Protrusion (mm) Total Height (mm)
BSP100-19 19 19 19 11 14
BSP100-21 21 21 21 11 15
BSP100-23 23 23 23 13 16
BSP100-25 25 25 25 13 17
BSP100-27 27 27 27 14 19

Biocor™ Stented Tissue Valve

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Contents: Mitral Stented Tissue Valve (1 unit per box)

Reorder Number Valve Size (mm) Tissue Annulus Diameter (mm) Internal Diameter (mm) Ventricle Protrusion (mm) Total Height (mm)
B100-25M-00 25 25 23 9 16
B100-27M-00 27 27 25 9 17
B100-29M-00 29 29 27 10 19
B100-31M-00 31 31 29 10 20
B100-33M-00 33 33 31 11 20

Evidence

Excellent Durability

The SJM Biocor triple composite design, unique pericardial shield, and FlexFit stent aid durability.

  • Triple Composite Design: Three separate porcine leaflets are cross-linked using low pressure fixation and matched to provide symmetrical stress distribution and optimal leaflet coaptation
  • Unique Pericardial Shield on Outflow Edge: Helps prevent risk of abrasion by providing tissue to tissue interface
    FlexFit Stent - Eases implantation and reduces stress on the leaflets
  • Supported by Long-Term Clinical Data: Pre-market approval data include 1,934 patients and nearly 10,000 patient years

In addition to strong durability in the aortic position, the SJM Biocor valve maintains durability in the even more challenging mitral position.

Freedom From Reoperation Due to SVD at 20 Years1

Actuarial Actual
>65 >65
AVR 92.1±3.9 96.8±0.9
MVR 88.0±8.1 96.7±2.3
Excellent Mid- and Long-Term Durability in Multiple Peer-Reviewed Publications

Actuarial Freedom from Reoperation Due to SVD (Unless Otherwise Noted)

Biocor Stented Valve long term durability

Competitive Hemodynamics

SJM Biocor Supra

The supraannular position of the SJM Biocor Supra provides an optimal stent to annulus ratio, maximizing flow. It’s easy to see the larger diameter of the orifice area afforded by the position of the valve above the annulus.

In-Vivo Effective Orifice Area

PMA Data, One Year Post-Op (Unless Otherwise Noted)

Biocor Stented Valve invivoea

Note: Derived data for Biocor Supra 19mm, 21mm, 23mm is based on in-vivo Biocor standard aortic data for 21mm, 23mm and 25mm, respectively.


References

1. Mykén P. Two Decades With The St Jude Med. Biocor Bioprosthesis. Third Biennial Meeting of the Society for Heart Valve Disease, 2005.
2. Bottio T, Rizzoli G, Gerosa G, et al. Mid-term follow-up in patients with Biocor porcine bioprosthesis. Cardiovasc Surg. 2002 Jun;10(3):238-44. Study size=446. n=2. Implant years (1991-2001). Mean age 73.4 years. Mean follow-up years=3.25.
3. Bottio T, Rizzoli G, Thiene G, et al. Hemodynamic and clinical outcomes with the Biocor valve in the aortic position: an 8-year experience. J Thorac Cardiovas Surg. 2004 June;127(6):1616-23. Study size=257. n=17. Implant years (1992-2001). Mean age 75 years. Mean follow-up years=5.
4. Mykén P. Seventeen-Year Experience with the St. Jude Medical Biocor Porcine Bioprosthesis. JHVD 2005;14:486-92. Study size=1,283 AVR; 172 MVR. n=5 AVR; n=2 MVR. Implant years (1983-2000). Mean age 70 years AVR; 64 years MVR. Mean follow-up years=5.1 AVR; 5.8 MVR.
5. Rizzoli G, Bottio T, Vida, V, et al. Intermediate results of isolated mitral valve replacement with a Biocor porcine valve. J Thorac Cardiovasc Surg. 2005 Feb;129(2):332-9. Study size=154. n=20. Implant years (1992-2004). Mean age 72.3 years. Mean follow-up years=4.4.
6. Medtronic, Inc. Hancock II bioprosthesis, results from a multicenter clinical investigation, Clinical Compendium.UC199802821d EN. 2003. Study size = 267. n = 43. Implant years (1984-87). Median age 67 years.
7. Corbineau H, De La Tour B, Verhoye JP, et al. Carpentier-Edwards supraannular porcine bioprosthesis in aortic position: 16-year experience. Ann Thorac Surg 2001;71:S228-31. Study size = 278 AVR. n = not available. Implant years (1983-86). Mean age 69.4 years.
8. Banbury MK, Cosgrove III DM, White JA, et al. Age and valve size effect on the long-term durability of the Carpentier-Edwards aortic pericardial bioprosthesis. Ann Thorac Surg 2001; 72:753-7.Study size = 267 AVR. n = 43. Implant years (1981-84). Mean age 65 years.
9. Edwards Lifesciences LLC. Clinical Communiqué - 20 year results, Carpentier-Edwards PERIMOUNT aortic pericardial bioprosthesis. AR00163. 2003. Study size = 267 AVR. n = 2. Implant years (1981- 83). Mean age 65 years.
10. Medtronic, Inc. Mosaic aortic and mitral bioprosthesis, eight year Clinical Compendium. UC200202659c EN. 2004. Study size = 797 AVR. n = 25. Implant years (1994-98). Mean age 69 years.
11. Medtronic, Inc. Hancock II bioprosthesis, results from a multicenter clinical investigation, Clinical Compendium.UC199802821d EN. 2003. Study size = 102. n = 8. Implant years (1984-87). Median age 65 years.
12. Edwards Lifesciences LLC. Clinical Communiqué - 16 year results, Carpentier-Edwards PERIMOUNT mitral pericardial bioprosthesis, model 6900. AR00321. 2003. Study size = 435 MVR. n = 7. Implant years (1984-89). Mean age 60.7 years.
13. Jamieson WRE, Burr LH, Munro AI, et al. Carpentier-Edwards Standard porcine bioprosthesis: a 21-year experience. Ann Thorac Surg 1998;66:S40-3. Study size = 478 MVR. n = 214. Implant years (1975-88). Mean age 57.9 years.
14. Medtronic, Inc. Mosaic aortic and mitral bioprosthesis, eight year Clinical Compendium. UC200202659c EN. 2004. Study size = 232 MVR. n = 6. Implant years (1994-99). Mean age 67 years.
15. St. Jude Medical, Inc., Pre-Market Approval Application - Supplement to Summary of Safety and Effectiveness; 2005. P040021 (Italy Subset).
16. Medtronic, Inc., Pre-Market Approval Application - Supplement to Summary of Safety and Effectiveness; Medtronic Hancock II heart valve. Washington D.C., U.S. Food and Drug Administration. 1999. P980043.
17. Medtronic, Inc., Pre-Market Approval Application - Supplement to Summary of Safety and Effectiveness; MOSAIC Porcine Bioprosthesis. Washington D.C., U.S. Food and Drug Administration. 2000. P990064.
18. Baxter Healthcare Corporation, Pre-Market Approval Application - Supplement to Summary of Safety and Effectiveness; Carpentier-Edwards Pericardial Bioprosthesis, Model 2700;1991. P860057.
19. Medtronic, Inc. Instructions for Use. Mosaic Porcine Bioprosthesis (Ultra).
20. Baxter Healthcare Corportion. Instruction for Use. Carpentier-Edwards Pericardial Bioprosthesis,Model 2800 (RSR-Reduced Sewing Ring).
21. Edwards Lifesciences. Instructions for Use. Carpentier-Edwards Pericardial Bioprosthesis, Model 3000 (Magna).


Indications, Safety & Warnings
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St. Jude Medical Stented Tissue Valves are indicated for use as a replacement for malfunctioning native or prosthetic aortic and/or mitral valves. Adverse events potentially associated with the use of bioprosthetic heart valves include: angina, cardiac arrhythmia, endocarditis, heart failure, hemolysis, hemolytic anemia, hemorrhage (anticoagulant/antiplatelet-related), leak (transvalvular or paravalvular), myocardial infarction, nonstructural dysfunction (e.g., pannus, suture, inappropriate sizing, or other), prosthesis regurgitation, stroke, structural deterioration (e.g., calcification, leaflet tear, or other), thromboembolism and valve thrombosis. It is possible that these complications could lead to reoperation, explantation, permanent disability or death. Long-term anticoagulation and/or anti-platelet therapy should be considered in patients with dilated left atrium, a history of thrombotic events or a cardiac rhythm of atrial fibrillation or flutter. Please see the Instructions for Use (IFU) for a full description of indications, contraindications, side effects, precautions, warnings and Instructions for Use.
Last Updated: April 19, 2013