SJM Biocor Stented Valve System with FlexFit Stent

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SJM Biocor
®
Stented Valve System
with FlexFit™ Stent
Experience ease of implant with just one touch.
LOW IMPLANT
PROFILE
FlexFit ™
POLYMER STENT
SUTURE–
FRIENDLY CUFF
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The implantability leader in both aortic and mitral positions.
SJM Biocor Stented Valve System. Feeling is believing.
®
SJM Biocor® Stented Valve System
Introducing the lowest stent posts and base on the market today.
Unique FlexFit™ Polymer Stent
The SJM Biocor® Stented Valve System 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.
• Adapts easily to the annulus and enhances knot positioning.
Low Stent Posts
• Minimize aortic wall protrusion and reduce left ventricular outflow tract obstruction
in the mitral position.
Mitral Valve
LOW STENT POSTS AND BASE
Low Stent Base
• Reduces risk of LV outflow tract
• Provides optimal coronary ostia clearance.
9mm
ventricular protrusion
Suture-Friendly Cuff
• Minimizes suture drag and parachuting forces.
[ 27mm ]
obstruction in the mitral position.
• Improves implantability.
• Valve holder handle provides the option
for stent post deflection.
• Reduces potential for suture looping.
Aortic Valve
LOW STENT POSTS AND BASE
9mm
U N I Q U E FlexFit ™ STENT
aortic protrusion
• Reduces risk of aortic wall protrusion.
• Provides optimal ostia clearance in the aortic position.
• Enhances primary aortic closure.
[ 21mm ]
Supra Valve
LOW STENT POSTS AND BASE
11mm
SUTURE-FRIENDLY CUFF
aortic protrusion
SUPRAANNULAR CUFF
• Silicone ring shaped to provide anatomical fit.
• Cuff is optimized for supraannular implant.
SCALLOPED INFLOW EDGE
[ 21mm ]
Eases Implantation.
Minimizes suture drag
and parachuting forces.
Optimizes Valve Seating.
• Adapts easily to the annulus.
• Enhances knot positioning.
• Provides optimal coronary ostia clearance.
• Minimizes aortic wall protrusion.
• Reduces left ventricular outflow tract obstruction
in the mitral position.
SJM Biocor
Stented Valve System
with FlexFit™ Stent
®
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SJM Biocor Stented Valve System. Feeling is believing.
®
SJM Biocor Supra: Optimal stent to annulus ratio...
17-year published durability. 20-year clinical results.
®
The SJM Biocor® triple composite design, unique pericardial shield and FlexFit™ stent aid durability.
Unique FlexFit Polymer Stent
™
• Adapts easily to the annulus and enhances knot positioning.
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.
TRIPLE COMPOSITE DESIGN
Low Stent Posts
• Minimize aortic wall protrusion and reduce left ventricular outflow tract obstruction
in the mitral position.
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
TRIPLE COMPOSITE DESIGN
Helps prevent risk of abrasion by providing tissue-to-tissue interface.
Low Stent Base
FlexFit™ STENT
• Provides optimal coronary ostia clearance.
Eases implantation and reduces stress on the leaflets.
Suture-Friendly Cuff
SUPPORTED BY LONG-TERM CLINICAL DATA
• Minimizes suture drag and parachuting forces.
Pre-Market Approval data include 1,934 patients and nearly 10,000 patient years.
PERICARDIAL SHIELD
19mm
21mm
internal stent diameter
internal stent diameter
FlexFit ™ S T E N T
®
®
21mm Biocor
21mm Biocor Supra
Excellent durability in both the aortic and mitral positions.
U N I Q U E FlexFit ™ STENT
In addition to strong durability in the aortic position, the SJM Biocor® valve maintains strong durability in the even more
challenging mitral position.
...And improved hydrodynamic performance.
SJM Biocor® Demonstrates Excellent Mid- and Long-Term Durability in Multiple Peer Reviewed Publications
IN-VITRO PULSATILE FLOW PRESSURE GRADIENTS
Actuarial Freedom From Reoperation due to SVD (unless otherwise noted)
5
(Test Conditions: 5 liters/minute cardiac output (CO); 70 beats per minute (BPM))
100
80
70
SUTURE-FRIENDLY CUFF
SCALLOPED INFLOW EDGE
92%
95.8%
100%
90.5%
95.8%
20
All Ages; Both; 9 yrs*1
2
>65 yrs; Aortic; 8 yrs**
60
>60 yrs; Aortic; 17 yrs3
50
All Ages; Mitral; 8 yrs4
40
>60 yrs; Mitral; 17 yrs3
20.7
15
mmHg
90
20.7
SJM Biocor®
15.9
®
SJM Biocor Supra
15.9
12.8
10
5.0
30
0.0
20
Eases Implantation.
Minimizes suture drag
and parachuting forces.
Optimizes Valve Seating.
• Adapts easily to the annulus.
• Enhances knot positioning.
• Provides optimal coronary ostia clearance.
• Minimizes aortic wall protrusion.
• Reduces left ventricular outflow tract obstruction
in the mitral position.
10
0.0
* Freedom from Reop
** Freedom from SVD
19mm
21mm
23mm
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SJM Biocor
®
Stented Valve System
with FlexFit™ Stent
Reference Dimensions
Model Number
(Mitral)
B10-25M-00
B10-27M-00
B10-29M-00
B10-31M-00
B10-33M-00
Tissue Annulus
Diameter (mm)
25
27
29
31
33
Internal Diameter
(Stent ID mm)
23
25
27
29
31
Ventricular
Protrusion (mm)
9
9
10
10
11
Total Height
(mm)
16
17
19
20
20
Mitral
Model Number
(Aortic)
B10-21A-00
B10-23A-00
B10-25A-00
B10-27A-00
B10-29A-00
Tissue Annulus
Diameter (mm)
21
23
25
27
29
Internal Diameter
(Stent ID mm)
19
21
23
25
27
Aortic
Protrusion (mm)
9
9
10
11
12
Total Height
(mm)
14
15
16
17
19
Aortic
Model Number
(Supra)
B10SP-19
B10SP-21
B10SP-23
Tissue Annulus
Diameter (mm)
19
21
23
Internal Diameter
(Stent ID mm)
19
21
23
Aortic
Protrusion (mm)
11
11
13
Total
Height
I
(mm)
14
15
16
Supra
SJM Bioprosthetic Sizer Set
Model Number
Description
B807
SJM Biocor valve sizer set
Internal
Diameter
Internal
Diameter
Internal
Diameter
References:
1. 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.
2. 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.
3. 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.
4. 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.
5. Data on file at St. Jude Medical, Inc., 2005. Report number 871769.
VISIT OUR WEB SITE AT www.sjm.com
SJM Stented Tissue Valves are indicated for use as a replacement for malfunctioning native or prosthetic 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 physician’s manual for a full description of indications, contraindications, side effects, precautions,
warnings, and instructions for use.
Corporate Headquarters St. Jude Medical, Inc., One Lillehei Plaza, St. Paul, Minnesota 55117 USA 24-Hour Technical/Professional Consultation (800) 328-9634 (USA) (651) 483-2000 Fax: (651) 482-8318
Customer Service (800) 544-1664 (USA) (651) 490-4410 Fax: (651) 481-7702 European Headquarters St. Jude Medical Europe, Inc., The Corporate Village, Avenue Da Vinci laan, 11-Box F1, B-1935-Zaventem,
Belgium Customer Service Tel: 32-2-774-68-11 Fax: 32-2-772-83-84 Asian Asian Headquarters St. Jude Medical Hong Kong Limited, Room 2705-2708, China Merchants Tower, Shun Tak Centre, 168-200 Connaught
Road, Central, Hong Kong Tel: (852) 2996-7688 Fax: (852) 2956-0622.
SJM Biocor is a registered trademark of St. Jude Medical, Inc. FlexFit and The Global Leader in Heart Valve Devices are trademarks of St. Jude Medical, Inc. ©2005 St. Jude Medical, Inc. All rights reserved.
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