ATS 3f Enable Aortic Bioprosthesis Shows Early Promise

A total of 47 patients have now undergone aortic valve replacement with ATS Medical’s 3f Enable Aortic Bioprosthesis at seven investigative sites in Europe; eight patients have surpassed the two year implant duration.

In October 2006, ATS completed a $58 million purchase of 3F Therapeutics, a privately held developer of tissue heart valve products. This acquisition opened the door to the $600 million tissue valve market and brought less-invasive surgical technology to ATS – including the valve in question.

The ATS 3f Enable Aortic Bioprosthesis is designed to eliminate the traditional suturing needed to replace a diseased aortic heart valve. If suturing can be eliminated, surgeons can potentially reduce procedure time and offer less invasive treatment alternatives.

Friedrich Eckstein of the University Hospital of Bern stated, “Because we are able to eliminate the suturing and much of the time that normally accompanies aortic valve replacement, we have been able to provide more of our patients a less invasive procedure using smaller incisions without compromising clinical outcome.”

The elimination of suturing may also significantly improve valve related hemodynamics – allowing the surgeon to provide a replacement valve of a size larger than what is traditionally possible with conventionally sutured heart valves.

“Unlike with sutureless percutaneous valves, there has been no trade off or compromise in clinical performance,” said Thierry Carrel, also from the University Hospital of Bern, “Specifically, we have not observed any peri-valvular leaks or migration with the Enable prosthesis.”

The Enable ‘sutureless’ solution has provided excellent clinical outcomes for peri-valvular leak comparable to conventional surgery. It has also established that valve migration is not a risk with the Enable heart valve.

ATS has prior experience in the cardiac space having brought to market the ATS Open Pivot Heart Valve. More than 100,000 people have received an ATS Open Pivot Heart Valve to date.

ATS Medical’s U.S. sales organization is focuses sales and marketing efforts on developing awareness in the approximately 950 open heart centers across the country. Internationally, ATS has had a direct sales organization in France since 2003, a direct marketing organization in China since 2004, and a direct sales organization in Germany since 2005. The company also sells through an independent distribution network in other markets throughout the world.

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