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ATS Medical Provides Update on Clinical Progress of ATS 3f Enable Aortic Bioprosthesis
Date:11/28/2007

further established that valve migration has not been a risk with the ENABLE heart valve.

Prof. Thierry P. Carrel of the University Hospital of Bern, Switzerland stated, "We are very encouraged by our ATS 3f Enable heart valve experience. The unique sutureless implantation feature of the ENABLE valve provides several important clinical benefits for our patients. Notably, because the valve requires no sutures to implant we are able to put in a larger valve than would otherwise be possible using a conventionally sutured heart valve. As a result, the hemodynamic performance observed is truly outstanding. And unlike with sutureless percutaneous valves, there has been no trade off or compromise in clinical performance. Specifically, we have not observed any peri-valvular leaks or migration with the ENABLE prosthesis. Prof. Friedrich S. Eckstein, also of the University Hospital of Bern, added, "The ENABLE sutureless implant procedure is remarkably simple. 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."

ATS Medical Inc. President and CEO, Michael Dale said, "We are very pleased with the results from our updated pivotal protocol. The potential benefits of a sutureless aortic heart valve are many, but up until the introduction of the ENABLE heart valve, 'sutureless' designs could not claim equality with conventional surgery outcomes. This was particularly true with regard to peri-valvular leakage. For less invasive aortic valve surgery to move forward as a standard of care, clinical outcomes must be at least equivalent to conventional surgical technique. We believe these results for ENABLE demonstrate this is possible. Our intellectual property in this area is comprehensive and we believe our design is practical and with this milestone we look forward to
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SOURCE ATS Medical Inc.
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