ATS Medical Announces CE Mark Regulatory Approval for ATS CryoMaze(TM)

    MINNEAPOLIS, Aug. 14 /EMWNews/ -- ATS Medical, Inc.

(Nasdaq: ATSI), manufacturer and marketer of state-of-the-art cardiac

surgery products and services, today reported that it has received ISO

certification for its Quality System to manufacture and CE Mark approval to

distribute ATS CryoMaze(TM) cardiac ablation products in the European

Union, indicating it is in compliance with relevant European health, safety

and environmental protection legislation. These approvals, in combination

with the completion of transfer of the U.S. 510k rights and validation of

the manufacturing processes, enable the Company to sell the

ATS-manufactured product line into the U.S. and Europe.



    



    The regulatory approvals are the final step in the integration of the

surgical ablation business, which the Company acquired in June 2007. Since

the acquisition, the Company has purchased devices from the previous

manufacturer to support worldwide sales. In anticipation of these

approvals, the Company began ramping its manufacturing efforts in the

second quarter and believes its current manufacturing capacity is

sufficient to meet demand.



    "We are elated by the achievements of our manufacturing and regulatory

teams in obtaining these key certifications enabling us to supply both U.S.

and European markets with devices manufactured by ATS Medical," commented

Michael Dale, President and Chief Executive Officer of ATS Medical, Inc.

"We are extremely pleased with the market's acceptance of our ATS CryoMaze

products and believe this business will be a primary contributor to the

acceleration of revenue growth over the next several years. With the

integration process behind us, we are now able to focus our efforts on

manufacturing process improvements and cost reductions and have the

flexibility to develop new products on a reduced timeline."

    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 150,000 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.



    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 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, 2007 and its most recent quarterly

report on Form 10-Q.