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:7/22/2014)...   BioTE Medical , a leading provider ... pellets, today announced the addition of Dr. ... Rouzier is joining the BioTE Medical Advisory Board ... Rouzier was residency trained in Family Medicine and ... certified emergency physician still practicing at a large ...
(Date:7/22/2014)... 2014 CTD Holdings, Inc. (OTCQB:CTDH), a ... device, cosmetics, and other markets, announced today that it ... of qualified private investors led by Novit L.P., an ... The transaction involved the signing of a Securities Purchase ... Common Stock at a price per share of $1.00, ...
(Date:7/22/2014)... (PRWEB) July 22, 2014 ... attendance at the 2014 NCSL International Workshop and ... #423 will feature CONDEC pressure instrumentation, OIML M1 ... and the new, customized sets, Essential Weights™. , ... promote cooperative efforts in solving the common problems ...
(Date:7/22/2014)... Two new members were elected to ... its annual Shareholders Meeting on June 13: Kerry R. ... PFM Group, and Stephen T. Zarrilli, President and CEO ... election of Michael A. DiPiano, Managing General Partner of ... P. Jaffe, Esq., of Duane Morris LLP, as Director ...
Breaking Biology Technology:Dr. Neal Rouzier Joins BioTE Medical 2Dr. Neal Rouzier Joins BioTE Medical 3CTD Holdings Closes $1.725 Million Private Placement 2CTD Holdings Closes $1.725 Million Private Placement 3Rice Lake Weighing Systems Showcases Metrology Solutions for the 2014 NCSL International Workshop & Symposium 2Two New Members Elected to University City Science Center Board of Directors 2Two New Members Elected to University City Science Center Board of Directors 3
... 10 Endologix, Inc. (Nasdaq: ELGX ), developer of ... Lemaitre, former President and CEO of CoreValve, has joined the ... now has four independent directors and three non-independent directors. , ... pleased to welcome Dan Lemaitre to the Endologix Board of ...
... , ... signs of growth, Sidoti & Company, Wall Street,s largest, fastest-growing small cap ... unique investment opportunities within the micro cap market at the firm,s ... Grand Hyatt Hotel in New York, NY. , "Micro cap ...
... 10 /PRNewswire-FirstCall/ - YM BioSciences Inc. (NYSE Amex: YMI ... identifies and advances a diverse portfolio of promising cancer-related products ... the proposed transaction which would result in the merger of ... October 5, 2009. The board of directors of Cytopia has ...
Cached Biology Technology:Endologix Appoints Dan Lemaitre to its Board of Directors 2Technology, Biotech, Energy and Transportation Among the Industries to be Featured at Sidoti & Company's First Annual 2010 Micro Cap Conference 2YM BIOSCIENCES OFFER FOR CYTOPIA APPROVED TO PROCEED TO SHAREHOLDER VOTE BY AUSTRALIAN COURT 2YM BIOSCIENCES OFFER FOR CYTOPIA APPROVED TO PROCEED TO SHAREHOLDER VOTE BY AUSTRALIAN COURT 3YM BIOSCIENCES OFFER FOR CYTOPIA APPROVED TO PROCEED TO SHAREHOLDER VOTE BY AUSTRALIAN COURT 4
(Date:7/22/2014)... allergic to dust mites (and chances are you are), ... the University of Iowa have developed a vaccine that ... immune response. In animal tests, the nano-sized vaccine package ... to the allergens, according to the paper, published in ... Journal . One big reason why it works, ...
(Date:7/22/2014)... An international collaboration known as the ,1000 Bull Genomes ... beef and dairy cattle while also improving animal health ... based on sequencing the whole genomes of 234 individual ... millions -- are reported in the journal Nature ... could use this information to reduce or eliminate hereditary ...
(Date:7/22/2014)... that split light with uncanny precision are key ... computers that manipulate light instead of electricity. But ... etching them with a precise beam of electrons, ... researchers at Princeton and Columbia universities have proposed ... customize and grow these specialized materials, known as ...
Breaking Biology News(10 mins):Researchers create vaccine for dust-mite allergies 2Whole-genome sequencing of bulls in key beef and dairy breeds 2Technique simplifies the creation of high-tech crystals 2Technique simplifies the creation of high-tech crystals 3
... -- The Damon Runyon Cancer Research Foundation, a ... researchers and innovative cancer research, named 11 new ... Award Committee review. The recipients of this ... basic and translational cancer research in the laboratories ...
... just how big a carbon footprint is created by travel to ... kind in the world to look at this issue. It also ... as: Setting up audio/video facilities at airports ... to airports to see off friends and family., Situating luggage-drop facilities ...
... NARRAGANSETT, R.I. January 21, 2010 The bubbles ... and tickle your nose are exhibiting a behavior quite similar to ... physicist Helen Czerski. But while the champagne bubbles ... cause clouds to form and affect the climate. "Bubbles are ...
Cached Biology News:Damon Runyon Cancer Research Foundation awards prestigious fellowships to 11 top young scientists 2Damon Runyon Cancer Research Foundation awards prestigious fellowships to 11 top young scientists 3Saying goodbye at airports the green way 2Bubble physicist counts bubbles in the ocean to answer questions about climate, sound, light 2Bubble physicist counts bubbles in the ocean to answer questions about climate, sound, light 3
SHP-2 Antibody...
Anti human PPAR gamma2 mouse monoclonal antibody...
... The antiserum has been tested on tissue ... staining pattern obtained with AB1773 corresponds to ... with probes to GLYT2 mRNA and to ... Preabsorption of the antiserum with the immunogen ...
Mouse monoclonal [RIZ1723] to PRDM2/RIZ...
Biology Products: