BiocorTM Stented Valve with FlexFitTM System
One Lillehei Plaza
St. Paul, Minnesota
55117
United States
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651-483-2000
651-482-8318 FAX
800-544-1664 SALES
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PRODUCT FEATURES
- Superior Implantability
• Unique FlexFit polymer stent: 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
• Low stent base provides optimal coronary ostia clearance
• Suture-friendly cuff minimizes suture drag and parachuting forces
- Low Stent Posts and Base
Mitral Valve
• Reduce risk of LV outflow track obstruction in the mitral position
• Improve implantability
• Valve holder handle provides the option for stent post deflection
Aortic Valve
• Reduces risk of aortic wall protrusion
• Provides optimal ostia clearance in the aortic position
• Enhances primary aortic closure
Supra Valve
• Silicone ring shaped to provide anatomical fit
• Cuff is optimized for supraanunular implant
- Competitive Hemodynamics
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.
Indications The SJM BiocorTM valve is intended as a replacement for diseased, damaged, or malformed aortic or mitral native heart valve. It may also be used as a replacement for a previously implanted aortic or mitral prosthetic heart valve. Potential Adverse Events 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. Caution: Federal law (USA) restricts this device to sale by or on the order of a physician or properly licensed practitioner.
Please see the physician’s manual for detailed indications, contraindications, warnings, precautions and potential adverse events.