SJM Biocor® Stented Valve System with FlexFit™ Stent

This device is commercially available for use in the United States and select international markets.

The SJM Biocor Stented Valve System—which includes aortic, mitral, and supra valves—provides the industry's lowest 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.

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

Low Stent Posts

Photo: Low stent posts and base for aortic, mitral, and supra valves. The mitral valve reduces risk of LV outflow tract obstruction in the mitral position, improves implantability, valve holder handle provides the option for stent post deflection, and reduces potential for suture looping. The aortic valve reduces risk of of aortic wall protrusion, provides optimal ostia clearance in the aortic position, and enhances primary aortic closure. The supra valve has a supraannular cuff. It's silicone ring shaped to provide anatomical fit. The cuff is optimized for supraannular implant. 

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 System with FlexFit Stent long-term durability 

Long-Term Durability in Mitral Position (>60 Years)

Actuarial Freedom (%) from Reoperation Due to SVD

Long-term durability in the aortic positions (greater than 60 years). Actuarial freedom (percentage) from reoperation due to SVD. SJM Biocor Valve (17 years) at 90.5 percent. Medtronic Hancock II (14 years) at 88.6 percent. CE SAV (15 years) at 82.5 percent. CE Perimount (15 years) at 77 percent. CE Perimount (20 years) at 77 percent.

Long-Term Durability in Mitral Position (>60 Years)

Actuarial Freedom (%) from Reoperation Due to SVD

Long-term durability in the mitral positions (greater than 60 years). Actuarial freedom (percentage) from reoperation due to SVD. SJM Biocor Valve (17 years) at percent. Medtronic Hancock II (14 years) at 82.5 percent. CE Perimount (15 years) at 69.7 percent. CE Standard (15 years) at 22.8 percent. Note that Mosaic data reported to 7 years only.

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)
In-vivo effective orifice area. PMA data, one year post-op, unless otherwise noted. Comparison of the following devices: SJM Biocor Supra, SJM Biocor Aortic, Medtronic Hancock II Bioprosthesis, Medtronic Mosaic and Mosaic Ultra Bioprosthesis, Carpentier-Edwards Perimount (Models 2700, 2800-RSR, and 3000-Magna).
Note: Derived data for Biocor Supra 19mm, 21mm, 23mm is based on in-vivo Biocor standard aortic data for 21mm, 23mm and 25mm, respectively.

View SJM Biocor Stented Valve System Product Brochure [PDF 1.3MB]

View list of heart valve model numbers.

1Mykén P. Two Decades With The St Jude Med. Biocor Bioprosthesis. Third Biennial Meeting of the Society for Heart Valve Disease, 2005.

2Bottio 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.

3Bottio 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.

4Mykén 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.

5Rizzoli 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.

6Medtronic, 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.

7Corbineau 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.

8Banbury 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.

9Edwards 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.

10Medtronic, 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.

11Medtronic, 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.

12Edwards 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.

13Jamieson 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.

14Medtronic, 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.

15St. Jude Medical, Inc., Pre-Market Approval Application - Supplement to Summary of Safety and Effectiveness; 2005. P040021 (Italy Subset).

16Medtronic, 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.

17Medtronic, 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.

18Baxter Healthcare Corporation, Pre-Market Approval Application - Supplement to Summary of Safety and Effectiveness; Carpentier-Edwards Pericardial Bioprosthesis, Model 2700;1991. P860057.

19Medtronic, Inc. Instructions for Use. Mosaic Porcine Bioprosthesis (Ultra).

20Baxter Healthcare Corportion. Instruction for Use. Carpentier-Edwards Pericardial Bioprosthesis,Model 2800 (RSR-Reduced Sewing Ring).

21Edwards Lifesciences. Instructions for Use. Carpentier-Edwards Pericardial Bioprosthesis, Model 3000 (Magna).

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