MINNEAPOLIS, Jan. 25 /PRNewswire-FirstCall/ -- ATS Medical, Inc. (Nasdaq: ATSI), manufacturer and marketer of state-of-the-art cardiac surgery products and services today announced the first commercial implants of the ATS 3f Enable® Aortic Bioprosthesis were recently performed at the University of Berne Hospital, Berne, Switzerland by Lars Englberger, MD, Mario Stalder, MD, and Professor Thierry Carrel. The procedures were completed using a sutureless technique and the patients are recovering with no complications.
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The ATS 3f Enable valve is the first surgical aortic valve replacement approved for commercial use that is implanted using a sutureless technique. The Enable valve combines the ATS 3f® Aortic Bioprosthesis with over eight years of proven clinical performance and a self-expanding Nitinol™ frame to hold the valve in its optimal position eliminating the need for conventional sutures. This design allows the Enable valve to be folded into a small diameter and placed through a minimally invasive incision. The Enable valve preserves native stress distribution and provides a large orifice area with laminar flow for excellent hemodynamics.
Professor Thierry Carrel, Chief of Cardiac Surgery at the University of Berne commented, "The implants went smoothly. There were no paravalvular leaks and the valves provide excellent hemodynamic performance with low single digit gradients. The Enable valve will help us expand our number of minimally invasive procedures." He continued to say, "The Enable valve proves to be a true competitor for TAVI (Transcatheter Aortic Valve Implantation) because the diseased valve is removed, we can directly visualize the placement of the new valve thereby obtaining clinical outcomes similar to conventional procedures. He concluded by saying, "TAVI can be considered palliative whereas Enable is restorative."
Michael Dale, President and CEO of ATS Medical, stated, "These landmark procedures in Switzerland are a major milestone for the Enable platform with the goal of bringing this disruptive technology to the traditional surgical market. Ultimately we envision the Enable platform facilitating minimally invasive procedures for patients without compromising conventional surgical valve outcomes."
The Company is continuing to develop sutureless tissue valve technology for use in beating heart procedures based in part on the characteristics of the next generation of Enable valves. First in human studies of these novel technologies are targeted for 2010. Commercialization of a beating heart solution could occur within one to two years thereafter. An Enable valve that is compatible in beating heart procedures would enlarge the Company's market opportunity by providing a solution for those patients who are poor candidates to endure conventional surgery or prefer a more minimally invasive solution.
About ATS Medical
ATS Medical, Inc. is dedicated to 'Advancing The Standards' of cardiac surgery through the development, manufacturing and marketing of innovative products and services for the treatment of structural heart disease. ATS Medical serves the cardiac surgery community by focusing on two distinct but operationally synergistic market segments: heart valve disease therapy and surgical ablation of cardiac arrhythmias.
ATS was originally founded to develop the ATS Open Pivot® Heart Valve as a new mechanical heart valve standard of care. Today the ATS Open Pivot Heart Valve is the preferred mechanical heart valve in many markets around the world and the fastest growing mechanical prosthesis in the market. Building on this legacy and addressing the largest market segment in heart valve therapy, the ATS 3f® brand encompasses an innovative tissue heart valve portfolio to address conventional open surgery requirements as well as the growing demand for less invasive sutureless based procedures. The ATS 3f® portfolio includes offerings at various stages including early product development, pivotal clinical trials, and market commercialization. Completing the portfolio in heart valve therapy is the ATS Simulus® annuloplasty product line. Simulus products assist the surgeon in repairing a patient's native heart valve as an alternative to replacement. Continuing ATS Medical's focus on serving the cardiac surgery community are the ATS CryoMaze® products for surgical cryoablation of cardiac arrhythmias. ATS CryoMaze® products are used by surgeons to treat patients suffering from cardiac arrhythmias, the largest and fastest growing form of structural heart disease in populations over 60 years of age. The ATS Medical web site is http://www.atsmedical.com.
Cautionary Statements
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 impact of pending healthcare reforms, 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, 2008 and its most recent quarterly report on Form 10-Q.
SOURCE ATS Medical, Inc.
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(Logo: http://www.newscom.com/cgi-bin/prnh/20040202/ATSILOGO)
The ATS 3f Enable valve is the first surgical aortic valve replacement approved for commercial use that is implanted using a sutureless technique. The Enable valve combines the ATS 3f® Aortic Bioprosthesis with over eight years of proven clinical performance and a self-expanding Nitinol™ frame to hold the valve in its optimal position eliminating the need for conventional sutures. This design allows the Enable valve to be folded into a small diameter and placed through a minimally invasive incision. The Enable valve preserves native stress distribution and provides a large orifice area with laminar flow for excellent hemodynamics.
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Professor Thierry Carrel, Chief of Cardiac Surgery at the University of Berne commented, "The implants went smoothly. There were no paravalvular leaks and the valves provide excellent hemodynamic performance with low single digit gradients. The Enable valve will help us expand our number of minimally invasive procedures." He continued to say, "The Enable valve proves to be a true competitor for TAVI (Transcatheter Aortic Valve Implantation) because the diseased valve is removed, we can directly visualize the placement of the new valve thereby obtaining clinical outcomes similar to conventional procedures. He concluded by saying, "TAVI can be considered palliative whereas Enable is restorative."
Michael Dale, President and CEO of ATS Medical, stated, "These landmark procedures in Switzerland are a major milestone for the Enable platform with the goal of bringing this disruptive technology to the traditional surgical market. Ultimately we envision the Enable platform facilitating minimally invasive procedures for patients without compromising conventional surgical valve outcomes."
The Company is continuing to develop sutureless tissue valve technology for use in beating heart procedures based in part on the characteristics of the next generation of Enable valves. First in human studies of these novel technologies are targeted for 2010. Commercialization of a beating heart solution could occur within one to two years thereafter. An Enable valve that is compatible in beating heart procedures would enlarge the Company's market opportunity by providing a solution for those patients who are poor candidates to endure conventional surgery or prefer a more minimally invasive solution.
About ATS Medical
ATS Medical, Inc. is dedicated to 'Advancing The Standards' of cardiac surgery through the development, manufacturing and marketing of innovative products and services for the treatment of structural heart disease. ATS Medical serves the cardiac surgery community by focusing on two distinct but operationally synergistic market segments: heart valve disease therapy and surgical ablation of cardiac arrhythmias.
ATS was originally founded to develop the ATS Open Pivot® Heart Valve as a new mechanical heart valve standard of care. Today the ATS Open Pivot Heart Valve is the preferred mechanical heart valve in many markets around the world and the fastest growing mechanical prosthesis in the market. Building on this legacy and addressing the largest market segment in heart valve therapy, the ATS 3f® brand encompasses an innovative tissue heart valve portfolio to address conventional open surgery requirements as well as the growing demand for less invasive sutureless based procedures. The ATS 3f® portfolio includes offerings at various stages including early product development, pivotal clinical trials, and market commercialization. Completing the portfolio in heart valve therapy is the ATS Simulus® annuloplasty product line. Simulus products assist the surgeon in repairing a patient's native heart valve as an alternative to replacement. Continuing ATS Medical's focus on serving the cardiac surgery community are the ATS CryoMaze® products for surgical cryoablation of cardiac arrhythmias. ATS CryoMaze® products are used by surgeons to treat patients suffering from cardiac arrhythmias, the largest and fastest growing form of structural heart disease in populations over 60 years of age. The ATS Medical web site is http://www.atsmedical.com.
Cautionary Statements
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 impact of pending healthcare reforms, 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, 2008 and its most recent quarterly report on Form 10-Q.
SOURCE ATS Medical, Inc.
