MINNEAPOLIS, Nov. 28 /PRNewswire-FirstCall/ -- ATS Medical Inc. (Nasdaq: ATSI), manufacturer and marketer of state-of-the-art cardiac surgery products and services, today announced that a total of 47 patients have now undergone aortic valve replacement with its sutureless ATS 3f Enable(TM) Aortic Bioprosthesis at seven investigative sites in Europe within both the feasibility and pivotal clinical trial phases. Currently, eight patients have surpassed the two year implant duration.
The ATS 3f Enable Aortic Bioprosthesis is designed to eliminate the traditional suturing required to replace a patient's diseased aortic heart valve. If suturing can be eliminated from the procedure, surgeons can potentially reduce procedure time and offer less invasive options for the treatment of aortic valve disease. In addition, the elimination of suturing offers the potential to significantly improve valve related hemodynamics by allowing the surgeon to provide a replacement valve of a size larger than what is traditionally possible with conventionally sutured heart valves.
The most recent phase of the clinical trial was designed to evaluate the effectiveness of the ATS 3f Enable Aortic Bioprostheses "sutureless" solution with respect to hemodynamics, avoiding peri-valvular leakage, and valve migration post surgery. After more than 25 consecutive procedures within the pivotal trial phase utilizing an updated pivotal trial protocol, the ENABLE 'sutureless' solution has provided excellent clinical outcomes for peri-valvular leak comparable to conventional surgery. It has been 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 expanding our enrollment in this exciting clinical trial."
Prof. Sven Martens, MD, PhD, of Johann Wolfgang Goethe University Hospital in Frankfurt, Germany said, "The ATS 3f Enable Aortic Bioprosthesis has been chosen by us because of the excellent hemodynamics, especially in patients with a small aortic annulus. The early results are very promising and while more time is needed, we believe that for these patients, this device may truly advance the standard of care for aortic valve surgery."
The ATS 3f Enable Aortic Bioprosthesis is the second product stemming from the ATS 3f(R) Aortic Bioprosthesis platform. Utilizing the same valve leaflet design and materials, the company has been able to preserve excellent product performance and durability. ATS has now expanded into the sutureless implant procedure and will utilize these base products and technologies to further advance the standard of heart valve repair and replacement. ATS' strategy has been to develop and provide an excellent Aortic Bioprosthesis, to utilize this platform to improve standard aortic valve replacement surgery through sutureless products and procedures, and then to provide products and procedures to allow for minimally invasive heart valve repair and replacement in a safe and effective manner. The company will proceed with an expanded clinical evaluation at a select number of international sites as we proceed through the regulatory process for US IDE and International CE Mark approvals.
About ATS Medical
ATS Medical, Inc. provides innovative products and services focused on cardiac surgery. The company, global in scope, is headquartered in Minneapolis, Minnesota. More than 140,000 ATS Open Pivot(R) Heart Valves, which utilize a unique pivot design resulting in exceptional performance and low risk profile, have been implanted in patients worldwide. The ATS 3f(R) brand encompasses multiple tissue heart valve product offerings at varying steps from market introductions to clinical trials to development projects that incorporate less invasive valve replacement technology. ATS Medical's focus on serving the cardiac surgery community is further strengthened by offerings that include ATS Simulus(R) annuloplasty products for heart valve repair, ATS CryoMaze(TM) surgical ablation products, and RTI-Cardiovascular for allograft tissue services. The ATS Medical web site is http://www.atsmedical.com.
This Press Release contains forward-looking statements that may include statements regarding intent, belief or current expectations of the Company and its management. Actual results could differ materially from those projected in the forward looking statements as a result of a number of important factors, including the results of clinical trials, the timing of regulatory approvals, the integration of 3f Therapeutics and the surgical cryoablation business of CryoCath Technologies, Inc., regulatory actions, competition, pricing pressures, supplier actions and management of growth. For a discussion of these and other risks and uncertainties that could affect the Company's activities and results, please refer to the Company's filings with the Securities and Exchange Commission, including its Form 10-K for the year ended December 31, 2006 and its most recent quarterly report on Form 10-Q.
|SOURCE ATS Medical Inc.|
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