Navigation Links
ATS Medical Announces FDA Approval of the ATS 3f Aortic Bioprosthesis
Date:10/30/2008

MINNEAPOLIS, Oct. 30 /PRNewswire-FirstCall/ -- ATS Medical, Inc. (Nasdaq: ATSI), manufacturer and marketer of state-of-the-art cardiac surgery products and services, today announced it has received U.S. Food and Drug Administration (FDA) approval for the ATS 3f(R) Aortic Bioprosthesis.

(Logo: http://www.newscom.com/cgi-bin/prnh/20040202/ATSILOGO)

This is the Company's first entry into the $400-plus Million U.S. tissue valve market. Based on the precept that 'Form Follows Function', the ATS 3f Aortic Bioprosthesis is a revolutionary next generation stentless pericardial aortic tissue valve that is unlike any other replacement valve.

Mimicking the native aortic valve's function as a tubular structure whose sides collapse in response to pressure, the ATS 3f Aortic Bioprosthesis is based on a proprietary valve design that reproduces the functional characteristics of the native aortic valve. This novel design results in a normal distribution of stress on the valve leaflets and laminar, non-turbulent blood flow across the prosthetic valve that is characteristic of a normal, native aortic valve.

With more than six years of clinical experience confirming excellent safety and efficacy, the ATS 3f Aortic Bioprosthesis' combination of normal blood flow dynamics and improved stress distribution provides surgeons and patients with a potentially more durable and physiologic solution to aortic valve replacement.

As one of the lead investigators in the pivotal clinical trial for the ATS 3f Aortic Bioprosthesis, Dr. Richard Shemin, Robert and Kelly Day Professor of Cardiothoracic Surgery, Chief, Division of Cardiovascular Center Executive Vice Chairman, Department of Surgery, David Geffen School of Medicine at UCLA, is eager to begin implanting the new pericardial tissue valve.

"The tubular design of the ATS 3f valve sets it apart from all other valves. The preservation of the aortic root is an innovative design element that returns native flow, increases coronary perfusion and appropriately distributes cardiac stress. In addition, the ease of implantation and potential for longer term durability makes this an excellent choice for my patients," added Dr. Shemin.

"This FDA approval is our first Class III PMA Approval since the reorganization of ATS Medical in October 2002 to become a leader in the treatment of structural heart disease with a focus on serving the unique requirements of cardiac surgeons," stated Michael Dale, Chairman, President and CEO. "This is a major milestone that will allow ATS Medical to leverage the expertise of our U.S. sales organization and capitalize on the significant brand equity we have established in the marketplace with the ATS Open Pivot(R) heart valve, ATS Simulus(TM) annuloplasty products and the ATS CryoMaze(TM) surgical ablation product line. Finally, this achievement is a testament to the competence, perseverance and vision of our employees, the founders of 3f and our clinical investigators who for more than six years committed themselves to bring an important solution forward for the advancement of cardiac surgery and patient well being." added Mr. Dale.

The ATS 3f Aortic Bioprosthesis is manufactured in Lake Forest, California, and is the first product within the 3f platform to earn FDA PMA approval. The second generation ATS 3f Enable(R) Aortic Bioprosthesis, which is comprised of the ATS 3f tissue valve mounted in a self expanding nitinol frame, is currently under clinical investigation in select centers in Europe with over 100 implanted patients. ATS Medical expects CE Mark approval of ATS 3f Enable in the first half of 2009.

ATS Medical will discuss its launch plans for the ATS 3f Aortic Bioprosthesis on its 2008 third quarter conference call, which is scheduled to occur after the market close on Monday, November 3, 2008.

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 160,000 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.


'/>"/>
SOURCE ATS Medical, Inc.
Copyright©2008 PR Newswire.
All rights reserved

Related medicine news :

1. AGA Medical to Appeal Ruling by Dutch Court in Lawsuit With Occlutech GmbH
2. Lifeclinic International Has Named John T. Kelly, M.D., Ph.D. Chief Medical Officer
3. National grants further WA Medical Research
4. Symmetry Medical to Report Third Quarter 2008 Financial Results on November 12, 2008
5. B. Braun Medical Inc. Launches Ambulatory Surgical Center Website
6. Palomar Medical Reports Financial Results for Third Quarter 2008
7. China Sky One Medical, Inc. Obtains Production Approval for Two New Drugs
8. Cardo Medical Announces FDA Clearance of the Align 360 Total Knee System
9. Guardian Provides National Access to In-Network Medical Benefits
10. American Medical Association Endorses CAQH CORE Effort to Standardize and Streamline Patient Administrative Data Exchange
11. Oaks Development Group Closes on 2.1 Acres for Medical Office Building in Palm Coast, FL
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:6/24/2016)... ... 2016 , ... A recent article published June 14 on E ... goes on to state that individuals are now more comfortable seeking to undergo not ... as calf and cheek reduction. The Los Angeles area medical group, Beverly Hills Physicians ...
(Date:6/24/2016)... ... June 24, 2016 , ... Marcy was in a crisis. Her son James, eight, was ... his family verbally and physically. , “When something upset him, he couldn’t control his emotions,” ... He would throw rocks at my other children and say he was going to kill ...
(Date:6/24/2016)... ... June 24, 2016 , ... Dr. Amanda ... orthodontic treatment. Dr. Cheng has extensive experience with all areas of orthodontics, including ... accelerated osteogenic orthodontics. , Micro-osteoperforation is a revolutionary adjunct to orthodontic treatment. ...
(Date:6/24/2016)... Plano, TX (PRWEB) , ... June 24, 2016 , ... ... taking part in Genome magazine’s Code Talker Award, an essay contest in which patients ... for an award to be presented at the 2016 National Society of Genetic Counselors ...
(Date:6/24/2016)... ... June 24, 2016 , ... ... Grove Investment Group (TGIG), has initiated cultivation and processing operations at its production ... and Pahrump, Nevada. , Puradigm is the manufacturer of a complete system of ...
Breaking Medicine News(10 mins):
(Date:6/23/2016)... DUBLIN , June 23, 2016 ... the "Pharmaceutical Excipients Market by Type (Organic Chemical ... Preservative), Formulation (Oral, Topical, Coating, Parenteral) - Global Forecast ... The global pharmaceutical excipients ... 2021 at a CAGR of 6.1% in the forecast ...
(Date:6/23/2016)... 2016 Research and Markets has announced ... report to their offering. ... a favourable commercial environment for MedImmune to enter. The US ... will serve to drive considerable growth for effective anti-influenza medications. ... cap sales considerably, but development is still in its infancy. ...
(Date:6/23/2016)... -- Revolutionary technology includes multi-speaker listening to ... leaders in advanced audiology and hearing aid technology, has ... the world,s first internet connected hearing aid that opens ...      (Photo: http://photos.prnewswire.com/prnh/20160622/382240 ) , ... firsts,: , TwinLink™ - the first dual ...
Breaking Medicine Technology: