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The ATS 3f Enable Aortic Bioprosthesis is designed to eliminate thetraditional suturing required to replace a patient's diseased aortic heartvalve. If suturing can be eliminated from the procedure, surgeons canpotentially reduce procedure time and offer less invasive options for thetreatment of aortic valve disease. In addition, the elimination of suturingoffers the potential to significantly improve valve related hemodynamics byallowing the surgeon to provide a replacement valve of a size larger than whatis traditionally possible with conventionally sutured heart valves.
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The most recent phase of the clinical trial was designed to evaluate theeffectiveness of the ATS 3f Enable Aortic Bioprostheses "sutureless" solutionwith respect to hemodynamics, avoiding peri-valvular leakage, and valvemigration post surgery. After more than 25 consecutive procedures within thepivotal trial phase utilizing an updated pivotal trial protocol, the ENABLE'sutureless' solution has provided excellent clinical outcomes forperi-valvular leak comparable to conventional surgery. It has been furtherestablished that valve migration has not been a risk with the ENABLE heartvalve.
Prof. Thierry P. Carrel of the University Hospital of Bern, Switzerlandstated, "We are very encouraged by our ATS 3f Enable heart valve experience.The unique sutureless implantation feature of the ENABLE valve providesseveral important clinical benefits for our patients. Notably, because thevalve requires no sutures to implant we are able to put in a larger valve thanwould otherwise be possible using a conventionally sutured heart valve. As aresult, the hemodynamic performance observed is truly outstanding. And unlikewith sutureless percutaneous valves, there has been no trade off or compromisein clinical performance. Specifically, we have not observed any peri-valvularleaks or migration with the ENABLE prosthesis. Prof. Friedrich S. Eckstein,also of the University Hospital of Bern, added, "The ENABLE sutureless implantprocedure is remarkably simple. Because we are able to eliminate the suturingand much of the time that normally accompanies aortic valve replacement, wehave been able to provide more of our patients a less invasive procedure usingsmaller incisions without compromising clinical outcome."
ATS Medical Inc. President and CEO, Michael Dale said, "We are verypleased with the results from our updated pivotal protocol. The potentialbenefits of a sutureless aortic heart valve are many, but up until theintroduction of the ENABLE heart valve, 'sutureless' designs could not claimequality with conventional surgery outcomes. This was particularly true withregard to peri-valvular leakage. For less invasive aortic valve surgery tomove forward as a standard of care, clinical outcomes must be at leastequivalent to conventional surgical technique. We believe these results forENABLE demonstrate this is possible. Our intellectual property in this area iscomprehensive and we believe our design is practical and with this milestonewe look forward to expanding our enrollment in this exciting clinical trial."
Prof. Sven Martens, MD, PhD, of Johann Wolfgang Goethe University Hospitalin Frankfurt, Germany said, "The ATS 3f Enable Aortic Bioprosthesis has beenchosen by us because of the excellent hemodynamics, especially in patientswith a small aortic annulus. The early resul
