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:5/25/2016)... ... May 25, 2016 , ... The American Medical Informatics ... of the National Coordinator for Health IT (ONC) outlining a measurement approach to ... were available when and where it was needed. The organization of health informatics ...
(Date:5/24/2016)... ... May 24, 2016 , ... ... and traumatic injuries, will be accelerated by research at Worcester Polytechnic Institute (WPI) ... of wound healing and tissue regeneration. , The novel method, developed by WPI ...
(Date:5/23/2016)... ... May 23, 2016 , ... PrecisionAg® Media has released ... and Beyond. The paper outlines the key trends that are creating both opportunities ... witnessed a lot of highs and lows as the precision agriculture market has ...
(Date:5/23/2016)... ... May 23, 2016 , ... ... on molecular nanotechnology, announced the winners for the 2015 Foresight Institute Feynman Prizes. ... are given in two categories, one for experiment and the other for theory ...
Breaking Biology Technology:
(Date:3/14/2016)... NXTD ) ("NXT-ID" or the "Company"), a company ... of a new series of commercials on Time Warner Cable ... .  The commercials will air on Bloomberg TV, Fox Business ... show. --> NXTD ) ("NXT-ID" or the "Company"), ... the airing of a new series of commercials on Time ...
(Date:3/10/2016)... India , March 10, 2016 ... a new market research report "Identity and Access Management ... & Audit, Compliance, and Governance), by Organization Size, by ... to 2020", published by MarketsandMarkets, The market is estimated ... USD 12.78 Billion by 2020, at a Compound Annual ...
(Date:3/9/2016)... March 9, 2016  Crossmatch ® , a ... solutions, today announced the addition of smart features ... multi-factor authentication platform. New contextual and application-specific ... step-up security where it,s needed most — while ... DC . --> Washington, ...
Breaking Biology News(10 mins):