Navigation Links
ATS Medical Provides Update on US Commercialization of Its ATS 3f Aortic Bioprosthesis
Date:12/8/2008

MINNEAPOLIS, Dec. 8 /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 FDA clearance for the marketing of the ATS 3f(R) Aortic Bioprosthesis that includes a new sewing tab material supplier and an improved valve holder accessory device.

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

While the ATS 3f Aortic Bioprosthesis PMA was approved on October 30, 2008, as previously indicated, a full commercial launch would commence in the first quarter of 2009 once these milestones were achieved. ATS Medical has achieved these milestones and is on track with the previous guidance. The ATS 3f Aortic Bioprosthesis is the Company's first entry into the $400-plus million U.S. tissue valve market.

"The FDA clearance was necessary for ATS Medical to commence a full commercial launch of our first tissue valve in the US. We are excited to achieve these important milestones for the Company," said Michael Dale, President and Chief Executive Officer of ATS Medical. "The tissue valve market presents the largest market opportunity for our Company and will importantly provide ATS Medical the leverage it needs to sustain high growth and enhanced profitability in the future."

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 valve. The tubular design of the ATS 3f Aortic Bioprosthesis maintains the continuity of the annulus and the sino tubular junction. No other valve mimics the native valve in this manner. By maintaining this continuity, the ATS 3f Aortic Bioprosthesis preserves the aortic sinuses and restores native valve stress distribution and physiologic blood flow. This elegant design provides surgeons and patients with a potentially more durable solution to aortic valve replacement. With more than six years of clinical experience confirming excellent safety and efficacy, the demonstrated clinical benefit and recent FDA approval of the ATS 3f Aortic Bioprosthesis are creating excitement and product demand among US surgeons.

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 outcome of pending litigation matters, 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 biology technology :

1. China Sky One Medical, Inc. Interviewed in The China Perspective
2. Favrille and MyMedicalRecords.com, Inc. Obtain Shareholder Approval to Move Forward With Merger
3. Advanced Technologies and Wireless Telecommunications Enhance Care and Medical Training at the Ryder Trauma Center in Miami
4. Transgenomic Signs Letter of Intent for an Agreement to Exclusive License With Option to Acquire Power3 Medical Products Neurodegenerative Diagnostics
5. Alfred Mann Foundation for Biomedical Engineering Launches New Web Site Designed to Help University Researchers Bring Biomedical Advances to Market
6. Delcath Adds University of Pittsburgh Medical Center to Phase III Trial
7. The Burnham Institute for Medical Research Becomes a GeneGo Center of Excellence Using MetaCore for Stem Cell Research and Neurology
8. Starch Medical Launches New, Bioinert Surgical Hemostats
9. Therapure Biopharma Inc. Announces Manufacturing Agreement with Biomedical Frontiers Incorporated -- Contract will Support Phase II Trials for Thalassemia Treatment
10. New Radiation-Blocking Medical Garments Introduced at RSNA Meeting in Chicago : Demron-M Technology Provides Total Protection in a Lightweight, Durable, Flexible Fabric
11. Shasta Regional Medical Center Awarded Full Accreditation from the Joint Commission
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:2/10/2016)... (PRWEB) , ... February 10, ... ... REGN) today announced that it has joined the Human Vaccines Project, a ... infectious diseases and cancer. , The Human Vaccines Project brings together ...
(Date:2/10/2016)... , Feb. 10, 2016  Matchbook, Inc., ... for fast growing biotech companies, announced today the ... Procurement Strategic Advisor. Jim brings nearly 25 years ... and procurement, having spent nearly two decades in ... Chain/Logistics and Procurement at Genzyme and, most recently ...
(Date:2/10/2016)... ... February 10, 2016 , ... LATHAM, NEW YORK... Marktech Optoelectronics ... West conference in San Francisco’s Moscone Center from February 16-18, 2016, and at ... , These latest InGaAs PIN diode standard packages feature a TO-46 metal can with ...
(Date:2/10/2016)... ... February 10, 2016 , ... Curoverse announced today that ... Arvados provides capabilities for managing and processing genomic and health data at petabyte ... institutions collecting and analyzing genomic data,” said Adam Berrey chief executive officer at ...
Breaking Biology Technology:
(Date:1/20/2016)... --  MedNet Solutions , an innovative SaaS-based eClinical technology ... is pleased to announce the attainment of record-setting corporate ... of the company,s laser focus on (and growing international ... comprehensive, easy-to-use and highly affordable cloud-based technology platform. ... growth achievements in 2015 include: , Record ...
(Date:1/15/2016)... Puerto Rico , Jan. 15, 2016 ... big and small to find new ways to ensure ... culture. iOS and Android ... based on biometrics, transforming it into a hardware authorization ... that users swipe their fingerprint on their KodeKey enabled ...
(Date:1/11/2016)... JOSE, Calif. , Jan. 11, 2016 ... of human interface solutions, today announced that its ClearPad ... driver integration (TDDI) products won two separate categories in ... Best Mobile Innovator and Best Technology Breakthrough. The Synaptics ... system cost, a simplified supply chain, thinner devices, brighter ...
Breaking Biology News(10 mins):