MINNEAPOLIS, Nov. 2 ATS Medical, Inc. (Nasdaq: ATSI), manufacturer and marketer of state-of-the-art cardiac surgery products and services, announced the first human robot assisted endoscopic aortic valve replacement using the daVinci® Surgical System from Intuitive Surgical (Nasdaq: ISRG) to implant the ATS 3f® Aortic Bioprosthesis. The procedure was performed by Allen Raczkowski, M.D., at Banner Baywood Health Hospital in Phoenix, Arizona.
"The ATS 3f Aortic Bioprosthesis is the only valve that has the extreme flexibility necessary for small access robotic ports and it provides excellent hemodynamic characteristics which are important for the patient's quality of life," said Dr. Raczkowski.
With the recent introduction of the ATS 3f Aortic Bioprosthesis into the U.S. marketplace, surgeons have quickly recognized its unique potential for use in less invasive port access and robot assisted procedures. Because the ATS 3f valve is the first truly stentless valve in the world, it has no rigid supporting stent. As a result, the valve is completely pliable which allows it to be folded into a small diameter and introduced to the body through small ports using minimally invasive techniques. No other commercially available valve can be manipulated in this manner. This successful first ever minimally invasive human aortic valve replacement is the result of an ongoing cooperative effort with many of the leading robot experienced cardiac surgery centers in the U.S. to develop minimally invasive aortic valve procedures.
"ATS Medical has been committed from the beginning to the development of minimally invasive solutions for the treatment of structural heart disease. The ability to remove and replace a diseased heart valve in a minimally invasive manner represents a dramatic benefit for patients for two reasons: better clinical outcomes by removing the diseased valve as opposed to leaving it in place, and secondly, a much more cosmetically favorable procedure versus the pain and scaring associated with conventional open chest surgery. This landmark robot assisted endoscopic aortic replacement procedure by Dr. Raczkowski is another important step toward providing surgeons and patients better options for the treatment of structural heart disease without an open sternotomy," stated Michael Dale, President and CEO of ATS Medical.
This procedure establishes the expansion of the Company's minimally invasive initiatives to the 3f product line in addition to the ongoing efforts with the ATS CryoMaze® Surgical System and the ATS Simulus® family of annuloplasty products. ATS has also created the position of "Business Development Manager of Minimally Invasive Procedures" to focus increased resources on the development of procedures and products to drive adoption, expand markets, and provide less traumatic surgical options for patients.
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 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(TM) products for surgical cryoablation of cardiac arrhythmias. ATS CryoMaze(TM) 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.
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, 2008 and its most recent quarterly report on Form 10-Q.
SOURCE ATS Medical, Inc.