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:10/31/2014)... Burlington, MA (PRWEB) October 31, 2014 ... is hosting a free learning webinar to introduce its ... managers, standards directors and biostatisticians. , Launched in September, ... the company's suite of clinical trial automation tools. For ... in a web browser. And by introducing Formations – ...
(Date:10/31/2014)... Brady (NYSE:BRC), a global leader in product ... video testimonial on the effectiveness of its FreezerBondz™ ... at the BloodCenter of Wisconsin discusses the challenges she ... of thousands of samples, and how the durability of ... we design our label materials with the harsh conditions ...
(Date:10/31/2014)... , Oct. 31, 2014  Tavistock Development ... by Tavistock Group, celebrated the groundbreaking of the ... City. The 92,000-square-foot, three-story facility ... Central Florida designed specifically for life ... the heart of the 650-acre Lake Nona Medical ...
(Date:10/30/2014)... 2014 Investor-Edge has initiated coverage ... ONVO), Medivation Inc. (NASDAQ: MDVN ), Pharmacyclics ... (NYSE MKT: SYN), and Ironwood Pharmaceuticals Inc. (NASDAQ: IRWD). ... at: http://investor-edge.com/register . On Wednesday, October ... 0.33%, the Dow Jones Industrial Average declined 0.18%, to ...
Breaking Biology Technology:Formedix to Introduce "Revolutionary" Clinical Trial Automation Software with Learning Webinar 2Brady Debuts New Lab Label Testimonial Video 2GuideWell Innovation Center Groundbreaking Hosted by Tavistock Development Company at Lake Nona Medical City 2GuideWell Innovation Center Groundbreaking Hosted by Tavistock Development Company at Lake Nona Medical City 3Biotech Equities Movers and Shakers - Organovo Holdings, Medivation, Pharmacyclics, Synthetic Biologics, and Ironwood Pharma 2Biotech Equities Movers and Shakers - Organovo Holdings, Medivation, Pharmacyclics, Synthetic Biologics, and Ironwood Pharma 3Biotech Equities Movers and Shakers - Organovo Holdings, Medivation, Pharmacyclics, Synthetic Biologics, and Ironwood Pharma 4Biotech Equities Movers and Shakers - Organovo Holdings, Medivation, Pharmacyclics, Synthetic Biologics, and Ironwood Pharma 5
... Inc.,(Nasdaq: VSCP ), a leading provider of ... 25, 2009 it will release its 2008,fourth quarter and ... 2008. The company will host a conference call ... 11:00 a.m. EST. , VirtualScopics, ...
... Include: - Initiation of development activities to ... Receipt of GRAS (Generally Recognized As Safe) ... commercialization in the U.S. and elsewhere- New ... Continued activities to support regulatory filings for ...
... LAIYANG, China, Feb. 12 /PRNewswire-Asia-FirstCall/ -- Genesis,Pharmaceuticals Enterprises, Inc. ... pharmaceutical company with its principal operations,in the People,s Republic ... conference call at 9:00 a.m. Eastern on Tuesday, February ... ended December 31, 2008 of,its fiscal year 2009. , ...
Cached Biology Technology:VirtualScopics Schedules Fourth Quarter 2008 Earnings Announcement 2VirtualScopics Schedules Fourth Quarter 2008 Earnings Announcement 3SENOMYX ANNOUNCES FOURTH QUARTER AND YEAR-END 2008 FINANCIAL RESULTS 2SENOMYX ANNOUNCES FOURTH QUARTER AND YEAR-END 2008 FINANCIAL RESULTS 3SENOMYX ANNOUNCES FOURTH QUARTER AND YEAR-END 2008 FINANCIAL RESULTS 4SENOMYX ANNOUNCES FOURTH QUARTER AND YEAR-END 2008 FINANCIAL RESULTS 5SENOMYX ANNOUNCES FOURTH QUARTER AND YEAR-END 2008 FINANCIAL RESULTS 6SENOMYX ANNOUNCES FOURTH QUARTER AND YEAR-END 2008 FINANCIAL RESULTS 7SENOMYX ANNOUNCES FOURTH QUARTER AND YEAR-END 2008 FINANCIAL RESULTS 8SENOMYX ANNOUNCES FOURTH QUARTER AND YEAR-END 2008 FINANCIAL RESULTS 9SENOMYX ANNOUNCES FOURTH QUARTER AND YEAR-END 2008 FINANCIAL RESULTS 10SENOMYX ANNOUNCES FOURTH QUARTER AND YEAR-END 2008 FINANCIAL RESULTS 11SENOMYX ANNOUNCES FOURTH QUARTER AND YEAR-END 2008 FINANCIAL RESULTS 12SENOMYX ANNOUNCES FOURTH QUARTER AND YEAR-END 2008 FINANCIAL RESULTS 13SENOMYX ANNOUNCES FOURTH QUARTER AND YEAR-END 2008 FINANCIAL RESULTS 14Genesis Pharmaceuticals Announces Conference Call to Discuss Results for its Second Quarter of FY 2009 2Genesis Pharmaceuticals Announces Conference Call to Discuss Results for its Second Quarter of FY 2009 3
(Date:10/30/2014)... DALLAS , Oct. 29, 2014 /PRNewswire/ ... and criminal justice technology solutions for public ... that it has deployed exciting enhancements to ... data analytics to provide actionable intelligence and ... Technologies continues to drive technological innovation through ...
(Date:10/29/2014)... registration is open for the Society ... Meeting. SIR 2015 is the one place ... and related health care professionals can come ... science and technologies being presented, discussed and ... in minimally invasive, image-guided medicine, SIR 2015 ...
(Date:10/29/2014)... City on September 19, 2014, leading geneticist and humanitarian ... Genome Sciences and Medicine at the University of Washington ... Tel Aviv University, was awarded the 2014 Lasker-Koshland Special ... her honorary degree from TAU, Prof. King was the ... and for the past 18 years she has been ...
Breaking Biology News(10 mins):Securus Technologies Adds Advanced Features to Its Industry-Leading Investigative Analytics Product 2SIR 2015: Interventional radiology shapes tomorrow's medicine 2Geneticist and humanitarian: Prof. Mary-Claire King receives Lasker Award 2
... in Biomed Central,s open access journal Journal of ... brain to develop Alzheimer,s disease. To date ... of inflammation in Alzheimer,s disease (AD), especially because trials ... ADAPT (The Alzheimer`s Disease Anti-inflammatory Prevention Trial) trial was ...
... Physics World, Steve Haake, director of the Centre for Sports ... the men,s 100 m sprint will be one event not ... the "performance-improvement index", which uses very simple physics to compare ... the last 100 years. The model shows that the ...
... next "next-gen" technology in genome sequencing has gotten a major ... Spring Harbor Laboratory (CSHL) and collaborators today published results of ... was recently introduced but whose use has so far been ... CSHL Assistant Professor Michael Schatz and Adam Phillippy and Sergey ...
Cached Biology News:Physics confirms sprinters are performing better than ever before 2An error-eliminating fix overcomes big problem in '3rd-gen' genome sequencing 2An error-eliminating fix overcomes big problem in '3rd-gen' genome sequencing 3
... The new D-LUX Detection Platform ... to provide the most sensitive, specific, ... qPCR. Invitrogens D-LUX Detection Platform offers ... equal to TaqMan probes, high signal/background ...
Provides continuous mixing action. For use with tubes, vials, and other containers...
... is aseptically collected via cardiac puncture from 3 ... mixed sex). It is then centrifuged and frozen ... filtered and bottled at 4C then stored at ... HAVE ALWAYS USED PEL-FREEZ COMPLEMENT, YOU CAN NOW ...
Modified and insect cell culture tested....
Biology Products: