The FDA has issued marketing approval to ATS Medical Inc., a Minneapolis, MN firm, for its AP360™ heart valve. We are not really sure how big the market for mechanical valves is, in view of the extensive availability of bioprosthetic ones, but surely there are some patients out there that will be implanted with pure mechanical devices.
So here are the features of the valve according to the manufacturer:
A flanged cuff of double-velour polyester for exceptional flexibility, needle penetration and conformability, making even the toughest implant easier. Single plane orifice facilitates valve seating and implant regardless of suture technique. Orifice design with strengthening band of MP35N (a cobaltchrome alloy) prevents orifice distortion, leaflet immobilization or escape while providing smooth and easy rotation. Minimal subannular exposure reduces likelihood of subaortic inflammation.
Product page…
Product brochure (PDF)…
Press release: ATS Medical Receives FDA Approval for AP360 Mechanical Heart Valve
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