Medtronic has reported positive five-year follow-up data demonstrating the safety and efficacy of its sutureless tissue heart valve, 3f Enable aortic bioprosthesis.
The study has demonstrated that patients implanted with 3f Enable aortic valve prosthesis did not showed structural valve deterioration at five years.
In addition, the study demonstrated 93% freedom from valve mortality at five years post-implant, a performance comparable to traditional surgical heart valves.
Medtronic has obtained CE Mark approval for 3f Enable in December 2009. The device is currently not approved for use in the US, Canada and Japan.
Medtronic claims that 3f Enable Bioprosthesis facilitates implantation using a minimal-invasive surgical technique to replace diseased, damaged or malfunctioning native or prosthetic aortic valves in aortic valve stenosis or aortic insufficiency patients.
The device can be implanted through an incision that is smaller than those commonly used for traditional surgical valve replacements, and without conventional sutures.
Made up of self-expanding Nitinol frame, the 3f Enable valve can be folded into a small diameter size so that it fits through the minimal incision. The valve is fixated in the valve’s annulus and can be repositioned as needed.
Medtronic senior vice president and Structural Heart Business president Dr John Liddicoat noted that this is the first time the company has seen five-year performance data of any sutureless valve on the market, and the results are quite impressive.
"The 3f Enable tissue heart valve not only provides a less invasive way to replace diseased, damaged or malfunctioning aortic valves, but now we know it performs well over time with excellent gradients, too," Dr Liddicoat added.
Medtronic has presented the results at the 94th American Association for Thoracic Surgery Annual Meeting in Toronto.