Healthcare Industry News: cryoablation
News Release - February 28, 2007
ATS Medical Reports on Regulatory Progress for the ATS 3f(R) Aortic BioprosthesisAustralian Government Provides Conditional Approval to Import
Application for Canadian Approval Submitted
United States FDA Completes Successful Site Inspection
MINNEAPOLIS, Feb. 28 (HSMN NewsFeed) -- ATS Medical, Inc. (Nasdaq: ATSI ) today reported several regulatory developments relating to the ATS 3f® Aortic Bioprosthesis. Conditional approval to import the prosthesis has been granted by the Australian Government's Department of Health and Aging, Therapeutics Goods Administration. With the Australian approval, the ATS 3f Aortic Bioprosthesis is now approved for distribution in 15 countries.
ATS Medical also reported that a submission for approval has been completed and delivered to Health Canada - Medical Device Bureau, Therapeutic Products Programme. The company will be actively working with the agency to ensure a complete and timely process. In addition, the United States Food & Drug Administration (FDA) recently conducted a successful site inspection of the Lake Forest, California manufacturing facility as part of the PMA process. These developments are highlights of the rapid progress achieved to date in expanding availability of the Company's first bioprosthetic offering to global markets.
The ATS 3f Aortic Bioprosthesis incorporates revolutionary design concepts intended to preserve native aortic root geometry and function. Through this unique approach, the prosthesis more closely mimics native valve function providing excellent hemodynamic performance that may contribute to improvements in key determinants of cardiovascular performance such as coronary blood flow and left ventricular mass regression. Promising data suggests that physiologic stresses, a detriment to bioprosthetic valve longevity, may be more efficiently distributed throughout the prosthetic's leaflets leading to improved durability.
ATS Medical has also worked closely with cardiovascular surgeons to refine the product's implant process. A proprietary holder system has been developed to aid in the prompt, consistent, and reproducible placement of the device. A new time saving preparatory product rinse procedure has also been developed, validated, and approved for clinical use. By virtue of its design the ATS 3f Aortic Bioprosthesis sets new standards for ease of implant. In the words of leading implant surgeon, Mr. Gianfranco Campalani, DMS, of the Royal Victoria Hospital, Belfast, Northern Ireland, "We were pleasantly surprised to find the combination of the new rinse procedure and holder system contributed to a noticeable decrease in implant time. A straight forward operative procedure is now even easier."
Michael Dale, President and CEO of ATS Medical noted, "We are very pleased with the rapid progress we are making to bring our first bioprosthesis to the global marketplace. Our continuing introduction of new products and innovations to the field of cardiac surgery allows us to further leverage the infrastructure we have built as we establish a foothold in the largest and fastest growing segment of the heart valve therapy marketplace."
About ATS Medical
ATS Medical, Inc. provides innovative products and services focused on cardiac surgery. The company, global in scope, has been headquartered in Minneapolis, Minnesota since its founding in 1991. More than 135,000 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 cardiac surgery is further strengthened by offerings that include ATS Simulus(TM) annuloplasty products for heart valve repair, SurgiFrost® and FrostByte(TM) products for surgical cryoablation of cardiac arrhythmias, RTI-Cardiovascular for allograft tissue services, and the development of PARSUS blood filtration technology. 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. 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, 2005, as amended, and its Form S-4 Registration Statement, as amended, filed with respect to the merger with 3F Therapeutics.
Source: ATS Medical
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