Navigation Links
Thoratec Announces FDA Approval of HeartMate II(R) for Destination Therapy
Date:1/20/2010

PLEASANTON, Calif., Jan. 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 received FDA approval of its PMA (Pre-Market Approval) supplement, allowing the use of its HeartMate II LVAS (Left Ventricular Assist System) for Destination Therapy (DT).  

With this approval, the HeartMate II can be used to provide long-term cardiac support for patients suffering from advanced-stage heart failure who are not eligible for transplantation. Thoratec said it will begin the rollout of the device for the DT indication immediately and has sufficient inventory to address the expected increase in demand. The device was approved for Bridge-to-Transplantation (BTT) in the U.S. under the original PMA in April 2008.

The approval allows the HeartMate II to be used in patients with New York Heart Association (NYHA) Class IIIB or IV end-stage left ventricular failure who have received optimal medical therapy for at least 45 of the last 60 days, and who are not candidates for cardiac transplantation. The PMA approval was based on a filing submitted in April 2009 that included two-year data on a pivotal study cohort of 200 randomized patients enrolled at 38 centers. Patients in the HeartMate II DT trial were randomized to the HeartMate II or the HeartMate® XVE—the only other device approved for DT—on a 2:1 basis, respectively. Patients in the pivotal cohort ranged in age from 26-81 years old, with a median age of 64 years. Also included in the primary analysis were data on 24 small BSA (body surface area) patients who because of their bod
'/>"/>

SOURCE Thoratec Corporation
Copyright©2010 PR Newswire.
All rights reserved

Page: 1 2 3 4 5 6

Related medicine technology :

1. Thoratec Announces FDA Approval of HeartMate II(R) for Bridge-To-Transplantation
2. Thoratec Says Interim Data Analysis Demonstrates Statistical Superiority for the HeartMate II(R) in Destination Therapy Trial
3. Thoratec Reports 14 Percent Growth in Cardiovascular Division Sales as Third Quarter Revenues Increase Nine Percent
4. Thoratec Presentation at Canaccord Adams Conference to be Webcast
5. Thoratec Investor Meeting to Review HeartMate II (R) Destination Therapy Trial Data to Be Webcast
6. Thoratec Presentation at Piper Jaffray Conference to be Webcast
7. Dendreon Announces Publication of Phase 1 Study Highlighting Immunologic and Clinical Activity of Lapuleucel-T (Neuvenge(R)) in Advanced Breast Cancer Patients
8. EDAP Announces Launch of Clinical Study Combining HIFU and Chemotherapy for Localized Aggressive High Risk Prostate Cancer
9. Cephalon Announces Positive Results from a Pivotal Study of FENTORA in Opioid-tolerant Patients with Non-cancer Breakthrough Pain
10. ADVENTRX Announces Fast Track Designation Granted By the FDA For CoFactor For the Treatment of Metastatic Colorectal Cancer
11. DOV Pharmaceutical, Inc. Announces Successful Phase Ib Results for DOV 21,947
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:12/24/2014)... Dec. 23, 2014 In response to urgent requests ... Sierra Leone , Direct Relief delivered two ... for the treatment of local health workers who contract Ebola ... dedicated Ebola care center was constructed for foreign health care ... not available for local Sierra Leonean health workers. ...
(Date:12/22/2014)... 2014 NxStage Medical, Inc. (NASDAQ: ... products, announced today that the U.S. Food and ... to perform hemodialysis overnight while the patient is ... NxStage,s® System One is the first and only ... indication. Home nocturnal hemodialysis is ...
(Date:12/22/2014)... Research and Markets ( http://www.researchandmarkets.com/research/hmlfbq/investment ... "Investment Analysis of the US Medical Device Sector ... http://photos.prnewswire.com/prnh/20130307/600769 This ... sector identifies the key trends and rationale for ... mergers and acquisitions. The study will ...
Breaking Medicine Technology:First Ebola Treatment Unit for Local Health Workers Arrives in Sierra Leone 2NxStage Receives FDA Clearance for Home Nocturnal Hemodialysis 2NxStage Receives FDA Clearance for Home Nocturnal Hemodialysis 3Investment Analysis of the US Medical Device Sector 2
... Inc. announced today that it has completed notifying customers ... ventilators in the United States and has confirmed that ... was initiated on October 11, 2011 to address a ... received no reports of ventilator malfunctions, failures or injuries ...
... 12, 2012 The Federal Trade Commission (FTC) announced ... to settle allegations that the company overcharged seniors and ... the FTC has concluded its investigation into charges alleging ... following the 2007 merger of mega-chain CVS with pharmacy ...
Cached Medicine Technology:Respironics, Inc. Completes Voluntary Recall Notification of a Limited Number of Trilogy 100 Ventilators 2NCPA Comments on FTC Action Against CVS Caremark, Vows to Continue PBM Transparency Efforts 2NCPA Comments on FTC Action Against CVS Caremark, Vows to Continue PBM Transparency Efforts 3
(Date:12/26/2014)... AZ (PRWEB) December 26, 2014 ... source for the best in heating, cooling and ... for 24 hour emergency services in 2014 with ... alike know that Arizona is known for its ... company that understands the intricacies and details of ...
(Date:12/25/2014)... TX (PRWEB) December 26, 2014 ... Market Analysis to 2023” focuses on the current ... opportunities in the colorectal cancer market. Stivarga is ... of colon or rectal cancer. Boehringer Ingelheim is ... for the treatment of refractory CRC in the ...
(Date:12/25/2014)... Recently, iFitDress.com, the popular online supplier of wedding dresses ... selection of black one-shoulder cocktail dresses . In addition, ... available at discounted prices, up to 70% off. ... three weeks only. You know, we have thousands of frequent ... our new items can visit our website for more details. ...
(Date:12/25/2014)... sells many bamboo products and the business is famous ... announces big discounts on its bamboo mats , which ... the world’s leader in bamboo flooring. According to the ... 2015. , The bamboo mats are made from well-treated ... the bamboo strips for the mats are boiled and ...
(Date:12/25/2014)... Dennis Thompson HealthDay Reporter ... sick children with complex chronic illnesses can receive effective, less ... home," with easy access to a team of dedicated health ... likely to become seriously ill and need either hospitalization or ... at an enhanced medical home clinic at the University of ...
Breaking Medicine News(10 mins):Health News:Parker & Sons Announces Record Demand For 24 Hour Emergency Services In 2014 With Regard To Air-Conditioning Systems 2Health News:Parker & Sons Announces Record Demand For 24 Hour Emergency Services In 2014 With Regard To Air-Conditioning Systems 3Health News:Nintedanib Colorectal Cancer Market Analysis and Forecast to 2023 Report at RnRMarketReserach.com 2Health News:Nintedanib Colorectal Cancer Market Analysis and Forecast to 2023 Report at RnRMarketReserach.com 3Health News:Nintedanib Colorectal Cancer Market Analysis and Forecast to 2023 Report at RnRMarketReserach.com 4Health News:iFitDress.com: Black One-Shoulder Cocktail Dresses for 2015 2Health News:Various Styles of Bamboo Mats in Many Colors from BambooFlooringChina.com 2Health News:Coordinated Care Through 'Medical Home' Best for Chronically Ill Kids: Study 2Health News:Coordinated Care Through 'Medical Home' Best for Chronically Ill Kids: Study 3
... Sunday, May 17, traffic near the University of Washington ... for the 27th annual Nordstrom Beat the Bridge to Beat ... Montlake Closures , From 7:30 a.m. until ... Street to 44th Avenue NE. 520 Ramp Closures ...
... 13 Helen Phillips may be the newest "Biggest Loser" ... achieving wellness. She knows "wellness" is about simple, everyday choices ... is like drinking wellness by the glass and is one ... joins the ranks of celebs and athletes to don a ...
... Speaker Nancy Pelosi received an "Award of Courage" ... future directions in the fight against HIV/AIDS. amfAR,s "Awards ... in recognition of the vision, determination, and courage that ... Other 2009 awardees are Senator Edward Kennedy, Dr. C. ...
... ,pill burden, has negative effects , , WEDNESDAY, May ... dialysis patients take, the more side effects they suffer ... study finds. , Dialysis patients have to take more ... this study, researchers at the Los Angeles Biomedical Research ...
... (CCHIT®) today announced that Glenwood System LLC’s ( http://www.GlenwoodSystems.com ) ... and meets the Certification Commission’s electronic health record (EHR) criteria ... and clinics where most Americans get their healthcare. , ... ...
... Inc. introduces KT Tape(TM) , the first-ever ... for consumer use. Kinesiology tape is a high performance ... muscle and joint injuries. Kinesiology tape has never been ... training to use it. Athletes no longer have to ...
Cached Medicine News:Health News:Nordstrom Beat the Bridge to Beat Diabetes Run to Temporarily Suspend Traffic in University District on Sunday, May 17 2Health News:Pelosi Remarks at amfAR Conference on Future Directions in Fight Against HIV/AIDS 2Health News:For Dialysis Patients, More Pills = Lower Quality of Life 2Health News:Glenwood System LLC'S GlaceEMR Receives 08 CCHIT Certification,Software Complies with Updated Interoperability Requirements 2Health News:Glenwood System LLC'S GlaceEMR Receives 08 CCHIT Certification,Software Complies with Updated Interoperability Requirements 3Health News:Glenwood System LLC'S GlaceEMR Receives 08 CCHIT Certification,Software Complies with Updated Interoperability Requirements 4Health News:KT Tape: Secret Weapon of Elite Athletes - Now Available to Everyone 2
... VersaPulse® PowerSuite™ holmium laser combines excellent ... precise, virtually bloodless procedures. It is ... and gall bladder stones of all ... surgical tool. Because its laser light ...
... The VersaPulse® PowerSuite™ holmium laser combines ... for precise, virtually bloodless procedures. It ... urinary and gall bladder stones of ... multipurpose surgical tool. Because its laser ...
Turnstile casting stand for easy and safe casting. The compact system sets up quickly and stores conveniently, and the non-stick coating prevents fiberglass or plaster from adhering to surface....
... features a unique self-contained delivery ... proven in Europe for more ... bone cement powder and liquid ... Cemex is designed to offer ...
Medicine Products: