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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, MN, December 7, 2009 -- 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


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.

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