Navigation Links
Thoratec Announces HeartMate II(R) PMA Will be Reviewed by FDA Advisory Panel
Date:8/19/2007

PLEASANTON, Calif., Aug. 15 /PRNewswire-FirstCall/ -- Thoratec Corporation (Nasdaq: THOR), a world leader in products to treat cardiovascular disease, said today that its PMA (PreMarket Application) seeking approval of its HeartMate II for bridge-to-transplantation will undergo review by an FDA advisory panel later this year.

The company said that it has been informed by the FDA that the tentative date for the review by a Circulatory Systems Device Advisory Panel is November 30, 2007.

Recently, the company announced it had filed an amendment to its PMA the week of July 23rd that it believed addressed all of the significant deficiencies outlined by the FDA in its comment letter. The company also announced that it has now responded to all outstanding questions raised in the FDA's comment letter.

Thoratec is a world leader in therapies to address advanced stage heart failure. The company's product lines include the Thoratec VAD(R) (Ventricular Assist Device) and HeartMate LVAS (Left Ventricular Assist System) with more than 11,000 devices implanted in patients suffering from heart failure. Additionally, its International Technidyne Corporation (ITC) division supplies blood testing and skin incision products. Thoratec is headquartered in Pleasanton, California. For more information, visit the company's websites at http://www.thoratec.com or http://www.itcmed.com.

This press release contains forward-looking statements, including but not exclusively those addressing future performance or timelines and milestones for clinical trials within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. These statements can be identified by the words, "believes," "expects," "projects," "will," and other similar words. Actual results, events or performance could differ materially from these forward-looking statements based on a variety of factors, many of which are beyond Thoratec's control. Therefore, readers are cautioned not to put undue reliance on these statements. Investors are cautioned that all such statements involve risks and uncertainties, including risks related to the development of new markets including Destination Therapy, the growth of existing market for our products, customer and physician acceptance of Thoratec products, the results of enrollment in and timing of clinical trials, including for the HeartMate II, the ability to improve financial performance, regulatory approval process, the effects of healthcare reimbursement and coverage policies and the effects of any merger and acquisition related activities. Forward-looking statements contained in this press release should be considered in light of these factors and those factors discussed from time to time in Thoratec's public reports filed with the Securities and Exchange Commission, such as those discussed under the heading, "Risk Factors," in Thoratec's most recent annual report on Form 10-K, and as may be updated in subsequent SEC filings. These forward-looking statements speak only as of the date hereof. Thoratec undertakes no obligation to publicly release the results of any revisions to these forward-looking statements that may be made to reflect events or circumstances after the date hereof, or to reflect the occurrence of unanticipated events.


'/>"/>
SOURCE Thoratec Corporation

Copyright©2007 PR Newswire.

Related biology technology :

1. Speaker announces business members of IT Task Force
2. Doyle announces technology tax credits for Berbee
3. Doyle announces new energy, global warming policies
4. Doyle announces $80M renewable energy strategy
5. GE announces first installation of Discovery VCT
6. UWM announces winners of RGI awards
7. Third Wave announces two senior management appointments
8. Mirus announces new method for making antibodies
9. Merge announces sofware updates, upcoming acquisition
10. Small Tree announces ethernet solution for Apple Xserv G5
11. TEKLYNX International announces new RFID software
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:12/2/2016)... ... 02, 2016 , ... Robots will storm the Prudential Center in Boston, MA ... event, which is held on the United Nations International Day of Persons with Disabilities, ... the workplace. Suitable Technologies is partnering with NTI to showcase how technology can help ...
(Date:12/2/2016)... world leader in rapid infectious disease tests, introduced the Company,s newest product, the INSTI ... (Photo: http://photos.prnewswire.com/prnh/20161201/444905 ) Continue Reading ... ... , bioLytical was invited by the Clinton ... HIV Self Test to 350 pharmacy representatives in Nairobi and ...
(Date:11/30/2016)... , November 30, 2016 The global ... few players hold a dominant share in the overall ... Laboratories International, Inc., and Merck KGaA, held a lion,s ... Transparency Market Research observes that these companies are expected ... development products that are do not require rabbit pyrogen ...
(Date:11/30/2016)... , Nov. 30, 2016  The Allen Institute ... Collection: the first publicly available collection of gene ... that target key cellular structures with unprecedented clarity. ... these powerful tools are a crucial first step ... better understand what makes human cells healthy and ...
Breaking Biology Technology:
(Date:6/20/2016)... DALLAS , June 20, 2016 ... criminal justice technology solutions for public safety, investigation, ... by the prisons involved, it has secured the ... Corrections (DOC) facilities for Managed Access Systems (MAS) ... (4) additional facilities to be installed by October, ...
(Date:6/7/2016)... 2016  Syngrafii Inc. and San Antonio Credit ... includes integrating Syngrafii,s patented LongPen™ eSignature "Wet" solution ... will result in greater convenience for SACU members ... maintaining existing document workflow and compliance requirements. ... Highlights: ...
(Date:6/1/2016)... , June 1, 2016 ... in Election Administration and Criminal Identification to Boost Global ... a recently released TechSci Research report, " Global Biometrics ... Region, Competition Forecast and Opportunities, 2011 - 2021", the ... billion by 2021, on account of growing security concerns ...
Breaking Biology News(10 mins):