Healthcare Industry News: cryoablation
News Release - August 14, 2008
ATS Medical Announces CE Mark Regulatory Approval for ATS CryoMaze(TM)MINNEAPOLIS, Aug. 14 (HSMN NewsFeed) -- 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® 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® 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® 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, 2007 and its most recent quarterly report on Form 10-Q.
Source: ATS Medical
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