Greater than 90% Success Rate at Six-Month Follow-up of 57 Patients
MINNEAPOLIS, Feb. 22 /PRNewswire-FirstCall/ -- ATS Medical, Inc. (Nasdaq: ATSI), manufacturer and marketer of state-of-the-art cardiac surgery products, today announced initial clinical results of stand-alone ablation procedures and an overall expansion into the stand-alone market, using the ATS CryoMaze(TM) product line. This line of surgical products, indicated for the treatment of cardiac arrhythmias, is designed to replicate the original cut-and-sew Maze procedure (also known as Cox-Maze-III) by freezing lines in the heart to re-direct electrical impulses. The Maze procedure is a widely known surgical technique developed by Dr. James L. Cox in the 1980s to treat atrial fibrillation (AF) with a high rate of long-term success.
Current stand-alone ATS CryoMaze experience
In Ft Lauderdale on January 27, Dr. Evelio Rodriguez of East Carolina University presented on six-month results of stand-alone AF ablations using ATS Medical cryoablation products. In the presentation, Dr. Rodriguez described the East Carolina University technique of performing a complete stand-alone Maze procedure using cryoablation and robotic technique. This technique is facilitated by the use of the da Vinci(R) Surgical System from Intuitive Surgical, Inc., (Nasdaq: ISRG) to manipulate the cryoablation probe inside of the heart. East Carolina University has treated 57 patients with fully robotic stand-alone cryoablation. Prior to the procedure, 54 of these patients had continuous Atrial Fibrillation, the most difficult type of AF to ablate. At six-months of follow-up over 90% of the patients were in sinus rhythm and only five of these patients were using antiarrhythmic medication. Dr. Rodriguez said, "Stand-alone ablation using the ATS cryoablation probes is a reliable method of replicating the complete Maze procedure, with initial success rates that are similar to Dr. Cox's original procedure, which was an extensive open chest surgical procedure."
East Carolina University is not alone in using ATS CryoMaze for stand-alone AF ablation. More than 15 centers in the United States alone have adopted ATS cryoablation products in stand-alone procedures. Like East Carolina University, several hospitals are leveraging the da Vinci(R) Surgical System as a part of the procedure while others are performing ATS CryoMaze ablations by manipulating the cryogenic probe by hand.
The strengths of the stand-alone procedure using ATS CryoMaze are that it can be done through a small incision, which is appealing to the patient, and provides clinical results similar to the original cut-and-sew full Maze procedure -- even in the patient populations that are historically the most difficult to ablate, especially for cardiologists. The robust clinical success of this procedure combined with the minimally invasive access site is leading to a rapid adoption of this procedure for surgical stand-alone procedures.
"Over the past several months ATS Medical has made significant progress in advancing its therapies for the surgical treatment of cardiac arrhythmias on a stand-alone or sole therapy basis," said Michael Dale, CEO and President of ATS Medical. "Specifically, we have proven that our current ATS CryoMaze products offer a successful, less invasive approach to treating cardiac arrhythmias. We believe that further clinical results like those reported by Dr. Rodriguez will position ATS as a leader in the emerging field of minimally invasive cardiac arrhythmia treatment, which we believe will be a multibillion dollar market opportunity by providing curative solutions for the more than 50 million patients worldwide who suffer from atrial fibrillation."
As previously announced, the Company hired Dr. James Cox as Medical Director, effective January 1, 2008. Dr. Cox is recognized and respected worldwide for his many contributions to cardiac surgery. In particular, Dr. Cox is recognized as the developer of the original surgical Maze procedure which serves as the "gold standard" for the treatment of atrial fibrillation. The Maze procedure is recognized to provide the highest success rate of any surgical or cardiology treatment for atrial fibrillation and is supported by longest-term clinical data extending more than fifteen years. Dr. Cox in conjunction with the Company's research, development, and marketing team are developing a series of products and programs designed to make the ATS CryoMaze products the source for the surgical treatment of atrial fibrillation through less-invasive approaches. The team's focus is on developing tools and techniques to replicate the gold standard Maze lesion set in both open chest and closed chest procedures.
Concomitant Treatment -- The most common surgical ablation procedure today is the concomitant procedure in which an ablation is performed in conjunction with other cardiac surgery, most typically a mitral valve repair or replacement. The ATS development team is focused on providing next generation tools to provide better ergonomics and access to the lesion sites required by the Maze procedure. The Company anticipates introducing a new ATS CryoMaze probe and clamp combinations during mid 2008.
Sole Therapy or Stand-Alone Treatment -- As described above, several approaches have been used to perform ATS CryoMaze ablations on a less invasive, closed chest basis. The Company's efforts under the guidance of Dr. Cox will be focused on supporting the procedures and bringing new products to market that enable these procedures in an easily reproducible method with the gold-standard success rates of the original Cox Maze procedure.
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 145,000 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, and ATS CryoMaze(TM) surgical ablation products. 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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