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

an amendment to the submission once we have complete two-year data on the primary patient cohort," said Gary F. Burbach, president and chief executive officer of Thoratec.

In December 2008, Thoratec received approval from the FDA to end randomization in the trial, based on a pre-specified interim analysis of 67 percent of the first 200 patients that showed that patients implanted with the HeartMate II achieved statistically superior outcomes versus those in the control group who were implanted with the HeartMate XVE. Based on that analysis, the study's Data Safety Monitoring Board concurred with Thoratec's recommendation to eliminate randomization for patients enrolled in the trial under FDA-approved CAPs.

Patients in the trial were randomized to the HeartMate II or the HeartMate XVE -- currently the only device approved for DT -- on a 2-1 basis, respectively. The primary endpoint at two years is survival while remaining free from stroke and the need for reoperation for pump repair or replacement. Secondary endpoints included adverse events, functional status, hospitalization, assessment of neuro-cognitive function and patient quality of life.

"The data from the trial demonstrate that the HeartMate II is superior to the XVE, based on device performance and the primary patient outcome of two-year survival free from stroke and reoperation for device replacement. The data also showed that key adverse events, such as infection, sepsis and right heart failure, were significantly lower for the HeartMate II versus the XVE. As a result, this submission seeking FDA approval for Destination Therapy is an important milestone in Thoratec's mission to bring breakthrough therapies and new hope to the thousands of patients and their families suffering from advanced heart failure, as well as the clinicians who work tirelessly to treat them," Burbach said.

"The commercial experience of the HeartMate II for BTT
'/>"/>

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:7/25/2014)... Sinovac Biotech Ltd. (Nasdaq: SVA ), a leading ... today announced that it will release its unaudited financial results ... close on Thursday, August 14, 2014 EDT. The Company will ... Friday, August 15, 2014, at 8:00 a.m. EDT (Friday, August ... the Company,s financial results and provide an update on recent ...
(Date:7/24/2014)... July 24, 2014 -- A novel combination of microscopy ... of Energy,s Oak Ridge National Laboratory an unprecedented look ... unusual physical and electrochemical properties. , The research ... affects the surface of a perovskite manganite, a complex ... new avenue to understand surface behavior could benefit researchers ...
(Date:7/24/2014)... , July 24, 2014  Now available is a ... Rehealth Regenerative Therapies , located in ... physically active people a new health option: stem ... of age, countless patients suffer from joint and muscle ... as muscle tears, torn rotator cuff, tennis elbow, and ...
(Date:7/24/2014)... -- ECC West Africa, LLC (ECC) signed a contract in ... Hospital (UCH) Ibadan Board of Management for the first ... and operate and maintain a new, state-of-the-art Cancer Institute ... first of the 4-phase project, ECC will conduct feasibility ... Ibadan intends to finance and develop the Cancer Institute ...
Breaking Biology Technology:Sinovac to Host Conference Call to Report Second Quarter 2014 Unaudited Financial Results 2ORNL study reveals new characteristics of complex oxide surfaces 2Stem Cells In Sports Injuries, Joints And Muscular Pain 2Stem Cells In Sports Injuries, Joints And Muscular Pain 3ECC Signs a Contract for the Finance, Design, and Construction of a Premier Cancer Institute in Ibadan, Nigeria 2
... Researcher Appreciation Event ... ... PHOENIX, Oct. 3 ThirdBiotech Inc., http://www.thirdbiotech.com, a biotechnology incubator ... Appreciation Event to be held on Thursday, October 23rd, 2008,between noon and ...
... http://www.amdl.com ),AMDL, Inc. (Amex: ADL ), a leading ... the US, today announced that the,Company will present at ... on Tuesday, October 7, 2008 at 10:30 a.m. ET. ... York Hotel in the Morosco Room., The Maxim ...
... Support R&D Efforts and Clinical Trials Advancing,the ... Oct. 3 Micromet, Inc. (Nasdaq:,MITI) ("Micromet" ... proprietary antibodies for the treatment of cancer, ... has closed its previously,announced $40 million private ...
Cached Biology Technology:First Annual Arizona Biotech Day Announced for October 23rd 2008 2First Annual Arizona Biotech Day Announced for October 23rd 2008 3AMDL, Inc. to Present at Maxim Group Growth Conference October 7, 2008 2AMDL, Inc. to Present at Maxim Group Growth Conference October 7, 2008 3Micromet Closes $40 Million Private Equity Placement 2Micromet Closes $40 Million Private Equity Placement 3Micromet Closes $40 Million Private Equity Placement 4
(Date:7/25/2014)... is a complex congenital central nervous system disease ... the neural tubes during the embryonic phase. Many ... fecal incontinence and neurocognitive retardation. Such problems decrease ... life. Researchers at Ankara Physical Medicine and Rehabilitation ... performance in children with SB, using the Pediatric ...
(Date:7/25/2014)... girls reach puberty is influenced by ,imprinted genes,a subset of ... gene. This is the first evidence that imprinted genes ... of this study were published today in the journal ... menarche, is a marker for the timing of puberty in ... varies between girls, is an inherited trait, and is linked ...
(Date:7/25/2014)... a molecular testing panel developed at UPMC greatly ... surgery for patients with thyroid nodules and cancer, ... Institute (UPCI), partner with UPMC CancerCenter., The test, ... other diagnostic testing agencies, improved the chances of ... percent, according to the study published this month ...
Breaking Biology News(10 mins):Could age of first period influence development of diseases in older women? 2Test increases odds of correct surgery for thyroid cancer patients 2Test increases odds of correct surgery for thyroid cancer patients 3
... European College of Neuropsychopharmacology (ECNP) is pleased to ... 2009 ECNP Neuropsychopharmacology Award in Basic Science Research ... into the neurochemical basis of substance addiction. ... in the field of neuropsychopharmacology and its closely ...
... Researchers have made significant advances in the treatment of metastatic ... treat successfully once it has started to spread according ... congress, ECCO 15 ESMO 34 [1], in Berlin on ... seen rapid and dramatic shrinking of metastatic tumours in patients ...
... research team at the National Institute of Standards and ... possible cancer therapy has uncovered a delicate balancing act ... says they should be. Just like individuals in a ... because they get close together, but not too close. ...
Cached Biology News:Trial of new treatment for advanced melanoma shows rapid shrinking of tumors 2Trial of new treatment for advanced melanoma shows rapid shrinking of tumors 3Therapeutic nanoparticles give new meaning to sugar-coating medicine 2
... It has been demonstrated that oxidative stress ... and cancer. Oxidative stress is the condition ... and physiological antioxidants exist leading to the ... response to oxidative stress is through several ...
... Human Serum-Single Donor • Human serum is ... found to be negative by a test ... Antibodies to Human Immunodeficiency Virus (Anti-HIV 1/2), ... Hepatitis B Surface Antigen (HbsAg) and Non-reactive ...
... Clean-up Micro Kit provides a fast and simple ... X-100 and other detergents from small samples of ... patented protein resin as an ion exchanger. Each ... of either acidic or basic protein.A complete kit ...
Compound(s) screened through any number of client selected assays. Client also selects number of concentrations and replicates....
Biology Products: