Healthcare Industry News:  cryoablation 

Devices Cardiology Regulatory

 News Release - December 7, 2009

ATS Medical Announces CE Mark Approval for the ATS 3f Enable Bioprosthesis

Enable is the First and Only Commercially Available Sutureless Surgical Tissue Valve

MINNEAPOLIS, Dec. 7 (Healthcare Sales & Marketing Network) -- ATS Medical, Inc. (Nasdaq: ATSI ), manufacturer and marketer of state-of-the-art cardiac surgery products and services today announced it has received CE Mark approval to distribute the ATS 3f Enable® Aortic Bioprosthesis in the European Union, indicating it is compliant with relevant European health, safety, and environmental protection legislation. The Enable valve is the first surgical aortic valve replacement approved for commercial use that is implanted using a sutureless technique. It is the first valve of the ATS 3f Enable platform which combines the novel 3f tubular pericardial valve design with its superior hemodynamic profiles and a self-expanding frame to hold the valve in its optimal position.

The goal of the Enable valve is to achieve a less invasive aortic valve replacement and reduce procedure times. Today, most aortic valve surgery cannot be done on a minimally invasive basis because precise suturing is difficult within the confined space of a minimally invasive procedure. The sutureless Enable valve can be folded into a small diameter to allow placement through a minimally invasive incision. Once the Enable valve is delivered to the site of the annulus, it is expanded to its preconfigured diameter and is held in place with a resistance fit.

"We have been implanting the ATS Enable valve for four years achieving excellent hemodynamic and safety results. This valve is an important step toward the goal of reducing procedure time and allowing for a more minimally invasive approach to conventional valve surgery," stated Professor Jerzy Sadowski MD, PhD, Jagiellonian University, Department of CV Surgery and Transplantology, Krakow, Poland. Professor Sadowski and his surgical team performed the first human implant of the Enable valve in January 2005.

"We are very excited to obtain the world's first approval for a surgical sutureless heart valve. This initial offering in the Enable platform is an important first step in bringing disruptive technology to the traditional surgical market. Ultimately, we envision the Enable platform facilitating minimally invasive procedures for patients with conventional surgical indications," stated Michael Dale, President and CEO of ATS Medical. "Additionally, by reducing procedural time and the trauma incurred with current conventional surgical procedures, we believe Enable may also become a viable solution for certain patients who are currently considered too sick for surgery."

Commercialization of the Enable valve will commence with a controlled market release at select surgical centers in Europe. These sites will serve as "Centers of Excellence" where surgeons throughout Europe will be trained in the state-of-the-art techniques used for implanting the Enable valve and will be instrumental in the development and launch of future generations of the ATS 3f Enable platform. Release of the second generation Enable is expected in the latter half of 2010.

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-man studies of these novel technologies are targeted for 2010. Commercialization of a beating heart solution could occur within one to two years thereafter. A valve 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.

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.

Safe Harbor

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

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