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:1/15/2014)... Rochester, NY (PRWEB) January 15, 2014 The ... cause a major disease. One of these latent viruses is ... is rheumatoid arthritis (RA). Rheumatoid arthritis (RA) is a chronic ... the theory, a study found that RA patients have high ...
(Date:1/15/2014)... , Jan. 15, 2014 TaiGen Biotechnology Company, ... exclusive agreement with R-Pharm, a leading Russian pharmaceutical company, ... the Russian Federation , ... Independent States (CIS). Nemonoxacin is a novel antibiotic for the ...
(Date:1/14/2014)... BURLINGAME, Calif. , Jan. 14, 2014 As pet owners ... no doubt many of them wrote: "Take better care of my ... and even designer clothes and top-brand carrying cases to take the ... Pet parents might also feel compelled to buy some pricey toys ...
(Date:1/14/2014)... (PRWEB) January 14, 2014 In recent ... motives and methods in product development and promotion has ... industry. This mistrust, fueled by concerns about the insidious ... by reports of spectacular fines to the world’s biggest ...
Breaking Biology Technology:Study: Rheumatoid Arthritis (RA) Patients Have EBV; The CBCD Says this is Consistent with Microcompetition 2Study: Rheumatoid Arthritis (RA) Patients Have EBV; The CBCD Says this is Consistent with Microcompetition 3TaiGen Biotechnology Signed Exclusive License Agreement with R-Pharm for Nemonoxacin (Taigexyn(R)) 2TaiGen Biotechnology Signed Exclusive License Agreement with R-Pharm for Nemonoxacin (Taigexyn(R)) 3TaiGen Biotechnology Signed Exclusive License Agreement with R-Pharm for Nemonoxacin (Taigexyn(R)) 4New Year's Resolution: Give Pets the Gift of Top-Notch Health Care 2The Sunshine Act: Necessary Regulation or Unnecessary Dysregulation? New Life Science Webinar Hosted by Xtalks and IRB Services 2The Sunshine Act: Necessary Regulation or Unnecessary Dysregulation? New Life Science Webinar Hosted by Xtalks and IRB Services 3
... , ... ... ... ...
... ... with the upside of not only producing a low sodium meat product but with ... ... manufacturer of value-added ingredients into the natural food, nutraceutical and medical food market, is ...
... ... ... ... ...
Cached Biology Technology:China Medical Technologies Reports Third Fiscal Quarter Financial Results 2China Medical Technologies Reports Third Fiscal Quarter Financial Results 3China Medical Technologies Reports Third Fiscal Quarter Financial Results 4China Medical Technologies Reports Third Fiscal Quarter Financial Results 5China Medical Technologies Reports Third Fiscal Quarter Financial Results 6China Medical Technologies Reports Third Fiscal Quarter Financial Results 7China Medical Technologies Reports Third Fiscal Quarter Financial Results 8China Medical Technologies Reports Third Fiscal Quarter Financial Results 9China Medical Technologies Reports Third Fiscal Quarter Financial Results 10China Medical Technologies Reports Third Fiscal Quarter Financial Results 11China Medical Technologies Reports Third Fiscal Quarter Financial Results 12China Medical Technologies Reports Third Fiscal Quarter Financial Results 13China Medical Technologies Reports Third Fiscal Quarter Financial Results 14China Medical Technologies Reports Third Fiscal Quarter Financial Results 15China Medical Technologies Reports Third Fiscal Quarter Financial Results 16China Medical Technologies Reports Third Fiscal Quarter Financial Results 17China Medical Technologies Reports Third Fiscal Quarter Financial Results 18China Medical Technologies Reports Third Fiscal Quarter Financial Results 19China Medical Technologies Reports Third Fiscal Quarter Financial Results 20China Medical Technologies Reports Third Fiscal Quarter Financial Results 21China Medical Technologies Reports Third Fiscal Quarter Financial Results 22New Study Shows Nu-Tek's Modified Potassium Chloride Improves Yields in Meat Processing 2New Study Shows Nu-Tek's Modified Potassium Chloride Improves Yields in Meat Processing 3Medivation to Host Conference Call at 8:30 a.m. Eastern Time Tomorrow to Discuss Phase 3 Trial Results for Dimebon in Alzheimer's Disease 2Medivation to Host Conference Call at 8:30 a.m. Eastern Time Tomorrow to Discuss Phase 3 Trial Results for Dimebon in Alzheimer's Disease 3
(Date:4/23/2014)... data shows Africa,s Congo rainforest, the second-largest tropical rainforest ... greenness over the past decade. , The study, led ... of New York, shows between 2000 and 2012 the ... intensified. The research, published Wednesday in Nature , ... explore the effects of long-term drought on the Congo ...
(Date:4/23/2014)... of asthma, allergies and other chronic inflammatory disorders among ... part to their reduced exposure to the microbes that ... paper. , The article, published in the journal ... in urban centers who have less access to green ... a condition caused by immune system dysfunction. , When ...
(Date:4/23/2014)... German . Man ... difference between sexes depends on one single element of the genome: ... two sexual chromosomes are X and Y, whereas women have two ... morphological and physiological differences between males and females. , But this ... the X and Y were identical, until the Y started to ...
Breaking Biology News(10 mins):NASA satellites show drought may take toll on Congo rainforest 2NASA satellites show drought may take toll on Congo rainforest 3Rural microbes could boost city dwellers' health 2Rural microbes could boost city dwellers' health 3Male or female? 2Male or female? 3
... KNOXVILLE -- Research by a small group of microbiologists ... of the Earth: the realm just beneath the deep ocean ... on our planet. Beth Orcutt, a post-doctoral fellow at ... presented her new findings about this little researched realm today ...
... research studies should not be disclosed to participants without ... of the European Society of Human Genetics today (Monday). ... Policy, Management and Evaluation at the University of Toronto, ... held by many ethicists that individual genetic research findings ...
... Researchers at Rice University, Purdue University and the ... about why some fluids containing polymers -- including saliva ... do not. The findings are published online this ... Study co-author Matteo Pasquali, professor in chemical and biomolecular ...
Cached Biology News:New research into the deep ocean floor yields promising results for microbiologists 2Should the results of individual genetic studies be disclosed to participants? 2Should the results of individual genetic studies be disclosed to participants? 3Answer to saliva mystery has practical impact 2
Porcine parvovirus and mycoplasma tested. Contains 0.5 g/L of trypsin (1:250) and 0.2 g/L of EDTA4Na in Hanks' Balanced Salt Solution without CaCl2 MgCl2 6H2O and MgSO4 7H2O. Contains phenol red....
Immunogen: Recombinant full length protein. Storage: -20 C, Avoid Freeze/Thaw Cycles...
Immunogen: Synthetic peptide: R(89) L A F T V D D N P T K P T T R Q R Y(107) Storage: -20 C, Avoid Freeze/Thaw Cycles...
...
Biology Products: