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

y size could not be randomized to the larger HeartMate XVE. The filing also included data on adjunctive cohorts totaling an additional 409 patients, including those who had been originally supported by a HeartMate XVE, and based on the need for device replacement, elected to receive a HeartMate II, as well as patients enrolled under Continuous Access Protocols (CAPs).

"This is truly a momentous day for the hundreds of thousands of underserved advanced-stage heart failure patients," noted Gary F. Burbach, president and chief executive officer of Thoratec. "Those who now have access to the device owe a great deal to the patients and clinicians who participated in this landmark trial.

"As the data from both the trial and the BTT commercial experience with the device demonstrate, the HeartMate II is a proven therapy that extends patients' lives while providing them a significantly improved quality of life. We have been laying the groundwork for the DT launch through both our device manufacturing initiatives and market development programs targeted to clinicians and the 76 centers that have received certification from Centers for Medicare and Medicaid Services (CMS) for DT reimbursement. In addition, this approval will facilitate our initiatives to build upon our already strong presence in Europe," he added.

As a condition of approval, Thoratec has agreed to a post-approval study of 247 patients who will be followed until outcome or two years, whichever occurs first. Thoratec will utilize the Interagency Registry for Mechanically Assisted Circulatory Support (INTERMACS) to collect the FDA-required data on outcomes, adverse events, functional status and quality of life. Thoratec has also agreed to conduct a second small study at three specific centers to collect data regarding the relationship between bleeding, thrombosis, von Willebrand syndrome and anticoagulation in
'/>"/>

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:10/22/2014)... Oct. 22, 2014 WHEN: Wednesday, October 29, ... registration available at: http://bit.ly/1yStiU9 SPEAKERS: ... and Visionary Innovation Research Group Senior Research ... self-assembling materials, nanobots and flexible electronics are ... transform our lives in the coming decades. ...
(Date:10/22/2014)... 22, 2014  Recently published clinical studies of Stretta ... substantial database of evidence. This data has led to ... therapy for sufferers of refractory GERD. ... supporting Stretta therapy as a safe and effective GERD ... therapy available to nearly 50 million Americans. The new ...
(Date:10/20/2014)... 20 de octubre de 2014  PneumRx, Inc. ... de la pulmonología intervencional, anunció hoy la conclusión ... 3 meses antes de lo programado. El Estudio Clínico ... dispositivo de investigación (IDE) aprobada por la FDA ... de espiral de reducción de volumen pulmonar PneumRx ...
Breaking Medicine Technology:Futuristic Technologies That Will Transform Our World Beyond 2030 2Futuristic Technologies That Will Transform Our World Beyond 2030 3Futuristic Technologies That Will Transform Our World Beyond 2030 4Recent Clinical Study Data Confirms Efficacy of Stretta Therapy - Spurs Additional Insurance Coverage and Financing Round 2PneumRx concluye inscripción en prueba fundamental RENEW 2PneumRx concluye inscripción en prueba fundamental RENEW 3
... 16, 2011 Reportlinker.com announces that ... is available in its catalogue: ... manufacturing and API sourcing in ... 2011 ...
... -- 3SBio Inc. (NASDAQ: SSRX ) ("3SBio" ... on researching, developing, manufacturing and marketing biopharmaceutical products, today ... and first half ended June 30, 2011. ... Total net revenues increased by 29.0% over the second ...
Cached Medicine Technology:Pharmaceutical Contract Manufacturing and API Sourcing in Central Europe and the Balkan States 2011 2Pharmaceutical Contract Manufacturing and API Sourcing in Central Europe and the Balkan States 2011 3Pharmaceutical Contract Manufacturing and API Sourcing in Central Europe and the Balkan States 2011 4Pharmaceutical Contract Manufacturing and API Sourcing in Central Europe and the Balkan States 2011 53SBio Inc. Announces Unaudited Second Quarter and First Half 2011 Results 23SBio Inc. Announces Unaudited Second Quarter and First Half 2011 Results 33SBio Inc. Announces Unaudited Second Quarter and First Half 2011 Results 43SBio Inc. Announces Unaudited Second Quarter and First Half 2011 Results 53SBio Inc. Announces Unaudited Second Quarter and First Half 2011 Results 63SBio Inc. Announces Unaudited Second Quarter and First Half 2011 Results 73SBio Inc. Announces Unaudited Second Quarter and First Half 2011 Results 83SBio Inc. Announces Unaudited Second Quarter and First Half 2011 Results 93SBio Inc. Announces Unaudited Second Quarter and First Half 2011 Results 103SBio Inc. Announces Unaudited Second Quarter and First Half 2011 Results 113SBio Inc. Announces Unaudited Second Quarter and First Half 2011 Results 123SBio Inc. Announces Unaudited Second Quarter and First Half 2011 Results 133SBio Inc. Announces Unaudited Second Quarter and First Half 2011 Results 143SBio Inc. Announces Unaudited Second Quarter and First Half 2011 Results 153SBio Inc. Announces Unaudited Second Quarter and First Half 2011 Results 163SBio Inc. Announces Unaudited Second Quarter and First Half 2011 Results 173SBio Inc. Announces Unaudited Second Quarter and First Half 2011 Results 183SBio Inc. Announces Unaudited Second Quarter and First Half 2011 Results 19
(Date:10/22/2014)... HealthDay Reporter , TUESDAY, Oct. 21, 2014 ... are only about half as likely as white women to ... indicates, and the racial disparity persists even when donor eggs ... white patients became pregnant after IVF, compared to about 17 ... cycles over two years to tease out the impact of ...
(Date:10/22/2014)... Salamon HealthDay Reporter TUESDAY, ... conventional in vitro fertilization (IVF) -- the incubation of embryos ... a device inside the vagina, new research suggests. Scientists ... called an INVOcell, might sharply cut costs for pricey IVF ... more accessible to those who don,t live near big-city assisted ...
(Date:10/22/2014)... Thompson HealthDay Reporter TUESDAY, Oct. ... with Ebola while working for NBC News in Liberia ... special isolation unit at Nebraska Medical Center in Omaha, where he ... Tuesday. A blood test confirmed by the U.S. Centers for ... home to Providence, R.I., NBC News reported Tuesday night. ...
(Date:10/20/2014)... 2014 Allegheny General Hospital’s (AGH) Cardiovascular ... physicians to repair a damaged mitral valve as the ... system, developed by Abbott Vascular , is designed ... life-threatening condition in which the heart’s mitral valve leaflets ... from the heart’s left ventricle into the left atrium. ...
(Date:10/20/2014)... Columbus, OH (PRWEB) October 20, 2014 ... joined Specialists in Obstetrics & Gynecology of Columbus, Inc., ... specialized women’s healthcare services to more than 100,000 patients ... care though all ages and stages of a women’s ... office locations in Westerville and Dublin. , ...
Breaking Medicine News(10 mins):Health News:Black Women Fare Worse With Fertility Treatments, Study Says 2Health News:Black Women Fare Worse With Fertility Treatments, Study Says 3Health News:Experimental Infertility Treatment Seems Effective, Cheaper 2Health News:Experimental Infertility Treatment Seems Effective, Cheaper 3Health News:Experimental Infertility Treatment Seems Effective, Cheaper 4Health News:U.S. Cameraman Treated for Ebola 'Free' of the Virus 2Health News:U.S. Cameraman Treated for Ebola 'Free' of the Virus 3Health News:Allegheny General Hospital Introduces New, Beating-Heart Procedure for Mitral Valve Repair 2Health News:Allegheny General Hospital Introduces New, Beating-Heart Procedure for Mitral Valve Repair 3Health News:OhioHealth Welcomes New Women’s Health Specialist to MaternOhio Specialists in Obstetrics & Gynecology of Columbus, Inc. 2Health News:OhioHealth Welcomes New Women’s Health Specialist to MaternOhio Specialists in Obstetrics & Gynecology of Columbus, Inc. 3
... http://www.westaim.com , CALGARY, Nov. 7 /PRNewswire-FirstCall/ - The ... on Tuesday, November 13, 2007 regarding the,Company,s 2007 third ... wire services, a news release,and financial statements will be ... call live on the Internet, please go to ...
... 7 Rapid Pathogen Screening Inc.,(RPS) -- a ... -- announced today that the American Medical Association ... that will cover the,RPS Adeno Detector(TM), effective January ... "Infectious agent antigen detection by immunoassay with direct ...
... The following is a,written statement by Kevin ... Force on Intellectual Property, at the Senate Judiciary,Committee ... Chairman Leahy, Ranking Member Specter, and Members ... discuss the Department of Justice,s,efforts to protect intellectual ...
... longer than previously assumed , WEDNESDAY, Nov. 7 (HealthDay ... according to a study that found the duration of ... That means many people may be getting booster shots ... say. , Based on the findings, it may be ...
... their risk for neurodevelopmental trouble, researchers say, , , WEDNESDAY, ... couldn,t live without their morning coffee, but caffeine may ... premature infants. , New research finds that high doses ... -- an average of 27 weeks gestation -- reduced ...
... NEWS, Va., Nov. 7 This past weekend ... Compact Gamma,Cameras" were presented at the Nuclear Science ... The goal of the laboratory study was to ... system in a configuration in which,the two imaging ...
Cached Medicine News:Health News:American Medical Association Clears Path for Adenoviral Conjunctivitis - 'Pink Eye' - Detector 2Health News:Written Statement of Kevin J. O'Connor, Chairman of the Department of Justice Task Force on Intellectual Property, at the Senate Judiciary Committee Hearing on Intellectual Property Enforcement 2Health News:Written Statement of Kevin J. O'Connor, Chairman of the Department of Justice Task Force on Intellectual Property, at the Senate Judiciary Committee Hearing on Intellectual Property Enforcement 3Health News:Written Statement of Kevin J. O'Connor, Chairman of the Department of Justice Task Force on Intellectual Property, at the Senate Judiciary Committee Hearing on Intellectual Property Enforcement 4Health News:Written Statement of Kevin J. O'Connor, Chairman of the Department of Justice Task Force on Intellectual Property, at the Senate Judiciary Committee Hearing on Intellectual Property Enforcement 5Health News:Written Statement of Kevin J. O'Connor, Chairman of the Department of Justice Task Force on Intellectual Property, at the Senate Judiciary Committee Hearing on Intellectual Property Enforcement 6Health News:Written Statement of Kevin J. O'Connor, Chairman of the Department of Justice Task Force on Intellectual Property, at the Senate Judiciary Committee Hearing on Intellectual Property Enforcement 7Health News:Written Statement of Kevin J. O'Connor, Chairman of the Department of Justice Task Force on Intellectual Property, at the Senate Judiciary Committee Hearing on Intellectual Property Enforcement 8Health News:Written Statement of Kevin J. O'Connor, Chairman of the Department of Justice Task Force on Intellectual Property, at the Senate Judiciary Committee Hearing on Intellectual Property Enforcement 9Health News:Written Statement of Kevin J. O'Connor, Chairman of the Department of Justice Task Force on Intellectual Property, at the Senate Judiciary Committee Hearing on Intellectual Property Enforcement 10Health News:Written Statement of Kevin J. O'Connor, Chairman of the Department of Justice Task Force on Intellectual Property, at the Senate Judiciary Committee Hearing on Intellectual Property Enforcement 11Health News:Written Statement of Kevin J. O'Connor, Chairman of the Department of Justice Task Force on Intellectual Property, at the Senate Judiciary Committee Hearing on Intellectual Property Enforcement 12Health News:Written Statement of Kevin J. O'Connor, Chairman of the Department of Justice Task Force on Intellectual Property, at the Senate Judiciary Committee Hearing on Intellectual Property Enforcement 13Health News:Written Statement of Kevin J. O'Connor, Chairman of the Department of Justice Task Force on Intellectual Property, at the Senate Judiciary Committee Hearing on Intellectual Property Enforcement 14Health News:Written Statement of Kevin J. O'Connor, Chairman of the Department of Justice Task Force on Intellectual Property, at the Senate Judiciary Committee Hearing on Intellectual Property Enforcement 15Health News:Written Statement of Kevin J. O'Connor, Chairman of the Department of Justice Task Force on Intellectual Property, at the Senate Judiciary Committee Hearing on Intellectual Property Enforcement 16Health News:Written Statement of Kevin J. O'Connor, Chairman of the Department of Justice Task Force on Intellectual Property, at the Senate Judiciary Committee Hearing on Intellectual Property Enforcement 17Health News:Written Statement of Kevin J. O'Connor, Chairman of the Department of Justice Task Force on Intellectual Property, at the Senate Judiciary Committee Hearing on Intellectual Property Enforcement 18Health News:Many Vaccine Booster Shots Unnecessary: Study 2Health News:Caffeine Therapy Boosts Preemies' Outcomes 2Health News:Caffeine Therapy Boosts Preemies' Outcomes 3Health News:Dilon Technologies Explores Improvements in Molecular Breast Imaging 2Health News:Dilon Technologies Explores Improvements in Molecular Breast Imaging 3
... is a user friendly computerized medical record ... efficiency and productivity of the practice as ... of documentation. It provides clinical templates for ... complaint. It also contains an exhaustive database ...
... applanation tonometer is designed to fit ... or most "Zeiss" style models. This ... intra-ocular pressure readings. The instrument stays ... and the prism is swung down ...
... first slit lamp truly designed from the ... video imaging. No other slit lamp on ... this exceptional product. The ReSeeVit 5V video ... the market to allow capture of clear, ...
... percent free PSA will help improve the accuracy ... multiple forms in the blood. Most is bound ... early 1990s, it was discovered that measuring the ... help in distinguishing prostate cancer from benign prostate ...
Medicine Products: