Navigation Links
Thoratec Announces Filing of PMA Seeking Destination Therapy Approval for HeartMate II(R)
Date:4/20/2009

PLEASANTON, Calif., April 20 /PRNewswire-FirstCall/ -- Thoratec Corporation (Nasdaq: THOR), a world leader in device-based mechanical circulatory support therapies to save, support and restore failing hearts, said today that it has filed a PMA (Pre-Market Approval) supplement with the FDA seeking to add the intended use of Destination Therapy (DT) for the HeartMate II LVAS (left ventricular assist system). The HeartMate II is a next generation heart assist device designed to provide long-term cardiac support for patients suffering from advanced stage heart failure. The device was approved for Bridge-to-Transplantation (BTT) in the U.S. under the original PMA in April 2008.

The PMA filing includes data on a pivotal study cohort of 200 randomized patients, including two-year data on the first 167 patients enrolled. Also included in the primary analysis are data on 24 small BSA (body surface area) patients who because of their body size could not be randomized to the larger HeartMate XVE. The filing also provides data on adjunctive cohorts totaling an additional 409 patients, including those who had been originally supported by an XVE who then elected to receive a HeartMate II, based on the need for device replacement, and patients enrolled under Continuous Access Protocols (CAPs). The company plans to file an amendment to the PMA supplement submission with complete two-year data on all 200 randomized patients at the end of June.

"We are pursuing this approach and making this submission at this time based on a series of discussions with the FDA. An interim analysis conducted at the end of 2008 for the primary endpoint demonstrated statistically significant superiority in favor of the HeartMate II versus the control group. As a result, Thoratec and the FDA have agreed that it is appropriate to make this filing now and to then file
'/>"/>

SOURCE Thoratec Corporation
Copyright©2009 PR Newswire.
All rights reserved

Page: 1 2 3 4

Related biology technology :

1. Thoratec Announces HeartMate II(R) PMA Will be Reviewed by FDA Advisory Panel
2. Thoratec Presentation at Bear Stearns Conference To Be Webcast
3. Thoratec Announces Appointment of Steven H. Collis to Board of Directors
4. Thoratec Presentation at JP Morgan Conference to be Webcast
5. Thoratec Reports 10 Percent Increase in Fiscal 2007 Revenues; Fourth Quarter Revenues Largest in Company History
6. Thoratec Schedules Third Quarter 2008 Conference Call, Webcast
7. Thoratec Reports 44 Percent Increase in Third Quarter Revenues
8. Thoratec Presentation at J.P. Morgan Conference to be Webcast
9. Dendreon Announces Publication of Phase 1 Study Highlighting Immunologic and Clinical Activity of Lapuleucel-T (Neuvenge(R)) in Advanced Breast Cancer Patients
10. YM BIOSCIENCES ANNOUNCES COMPLIANCE WITH AIM RULE 26
11. Emisphere Technologies, Inc. Announces Pricing of Registered Direct Offering
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:3/25/2015)... the most attractive in the emerging European region, mainly ... and increasing government investment in healthcare, according to a ... set to grow at twice the pace of the ... reaching an approximate market value of $43-60 billion by ... Cross provides total healthcare solutions that address the evolving ...
(Date:3/25/2015)... TORONTO , March 25, 2015 /PRNewswire/ - SQI Diagnostics ... announced that, as a result of recent discussions with ... common shares of the Company, after dealing with certain ... and special meeting of shareholders on March 26, 2015 ... that the election of directors will take place when ...
(Date:3/25/2015)... UK (PRWEB) March 25, 2015 ... uptake of smartphones have fuelled social media growth, ... being currently engaged in social networking. Insurance companies ... to communicate with clients and promote a diversity ... globe over are increasingly exploiting social networking services ...
(Date:3/25/2015)... IL (PRWEB) March 25, 2015 ... Symmetry® Top-Loading Balances and Analytical Balances to get ... expanded line of weighing balances from the trusted ... Toploading Balances increase your efficiency by providing ... variety of samples. Weighing modes include parts counting, ...
Breaking Biology Technology:SQI Diagnostics Inc. Announces New Nominees to SQI Diagnostics Board and Adjournment of Meeting 2SQI Diagnostics Inc. Announces New Nominees to SQI Diagnostics Board and Adjournment of Meeting 3SQI Diagnostics Inc. Announces New Nominees to SQI Diagnostics Board and Adjournment of Meeting 4SQI Diagnostics Inc. Announces New Nominees to SQI Diagnostics Board and Adjournment of Meeting 5Social Media Role in Global Insurance Industry Examined by Timetric in New Market Research Report Published at MarketPublishers.com 2Social Media Role in Global Insurance Industry Examined by Timetric in New Market Research Report Published at MarketPublishers.com 3New Economical Top-Loading and Analytical Symmetry Balances from Cole-Parmer 2
... 16 Medical and technical experts at Wyle are ... Station. Their efforts will help astronauts cope with effects ... in a future mission to Mars. , "If successful, ... exploration missions and provide us with better insight into ...
... , , SEATTLE, Nov. 16 ... "Company") today announced that the Company,s product candidate PX-866, ... Information, Inc., as one of the Top 10 most ... partnering. , The selection was made by an independent ...
... , LONDON, Nov. 16 The ... field of biomarker research will test the frontiers of biomedical ... day and this rapid development promises excellent growth potential for ... in biomarker validation and assay development, there is a huge ...
Cached Biology Technology:Wyle Personnel Take Part in Important Studies Aboard the International Space Station 2Wyle Personnel Take Part in Important Studies Aboard the International Space Station 3Oncothyreon's PX-866 PI-3 kinase inhibitor named among Top 10 most promising oncology products for partnering by Windhover 2Oncothyreon's PX-866 PI-3 kinase inhibitor named among Top 10 most promising oncology products for partnering by Windhover 3Frost & Sullivan Reveals Strategies on Turning Challenges into Opportunities in the European Biomarkers Market 2
(Date:3/3/2015)... LAKE FOREST, Calif. , March 3, ... ("Company"), the leading provider of advanced cryogenic ... serving markets including immunotherapies, stem cells, cell ... health, and reproductive medicine, today announced the ... Hutchinson Cancer Research Centers, ("Fred Hutch") ...
(Date:3/2/2015)... , March 2, 2015  Businesses have a ... protection company Tharon Rankins Enterprises has announced the ... an ultra-safe way for businesses to protect their ... transactions. Beconux is a biometric ... Enterprises. Functioning similarly to an ATM machine, the ...
(Date:2/25/2015)... 25, 2015  ABC Financial Services (ABC), the ... Health and Fitness Industry, today announced enhancements to ... The latest upgrade includes advances to the agreement ... check-in via Identity One fingerprint biometrics. The features ... interactive displays at the International Health, Racquet & ...
Breaking Biology News(10 mins):Cryoport, Inc. Expands Support of Fred Hutchinson Cancer Research Center's Clinical Research Division 2Cryoport, Inc. Expands Support of Fred Hutchinson Cancer Research Center's Clinical Research Division 3Personal Data Protection Company Launches New Product 2ABC Financial Unveils New Software Enhancements 2ABC Financial Unveils New Software Enhancements 3
... Mass. -- Many kinds of algae and cyanobacteria, common ... to split water molecules and release hydrogen, which holds ... future. One reason this approach hasn,t yet been harnessed ... production takes a back seat to the production of ...
... launch a new open access journal Human-centric Computing ... of the SpringerOpen portfolio, it will be fully sponsored ... Human-centric Computing and Information Sciences is ... The journal covers the multifaceted aspects of human-centric computing ...
... May 24, 2011 A gynecologist and a molecular biologist at ... time that pelvic organ prolapse a condition in which the ... by a combination of a loss of elasticity and a breakdown ... affects many women older than 50 years of age. Besides creating ...
Cached Biology News:MIT: Teaching algae to make fuel 2Springer launches new open access journal with Korean research society 2UT Southwestern researchers find protein breakdown contributes to pelvic organ prolapse 2