Navigation Links
Thoratec Announces Unanimous FDA Advisory Panel Recommendation for Approval of HeartMate II(R) for Bridge-to-Transplantation
Date:11/30/2007

PLEASANTON, Calif., Nov. 30 /PRNewswire-FirstCall/ -- Thoratec Corporation (Nasdaq: THOR), a world leader in products to treat cardiovascular disease, said today that the FDA Circulatory System Devices Advisory Panel has recommended unanimously that the agency approve, with conditions, the company's PMA (PreMarket Approval) allowing the use of its HeartMate II LVAS (Left Ventricular Assist System) as a bridge-to-transplantation (BTT).

The HeartMate II is a continuous flow device designed to provide long-term cardiac support for advanced-stage heart failure.

"We are delighted with the panel's recommendation indicating their belief that the data demonstrate the safety and efficacy of the device. This represents a major step in our program to make this state-of-the-art circulatory support technology commercially available in the U.S. for patients suffering from advanced-stage heart failure," said Gary F. Burbach, president and chief executive officer of Thoratec. "We believe the data reflect the positive experience of patients in the trial and that the HeartMate II represents a significant breakthrough in the treatment of heart failure and look forward to continuing what has been to date a positive dialogue with the FDA around this submission and achieving approval," he added.

The leading clinical presenters were Dr. Leslie Miller, Walters Chair of Cardiovascular Medicine and Director of Cardiology Programs at Washington Hospital Center & Georgetown University Hospital, and Dr. Francis Pagani, Director, Heart Transplant Program, University of Michigan Hospital.

The conditions outlined in the panel's recommendations related to clarifications on labeling for the device regarding small patients a
'/>"/>

SOURCE Thoratec Corporation
Copyright©2007 PR Newswire.
All rights reserved

0

GOOD

Page: 1 2 3

Related medicine news :

1. Thoratec Schedules Third Quarter Conference Call, Webcast
2. Thoratecs ITC Division Receives FDA Warning Letter
3. URGENT Thoratec Corporation Worldwide Recall of Implantable Ventricular Assist Device
4. HHS Announces $75 Million in Supplemental Funding to States for Pandemic Flu Preparedness
5. CRC Health Group Announces Acquisition of Bayside Marin Recovery Center, San Rafael
6. UHW Announces: Antelope Valley Hospital Caregivers and Board Vote to Ratify First Union Contract With SEIU UHW-West
7. HEI, Inc. Announces Sale of RFID Division Assets
8. Caraco Pharmaceutical Laboratories, Ltd. Announces FDA Approval to Market Generic Version of Zyloprim(R)
9. Mettler-Toledo International Inc. Announces Webcast of Presentation at Thomas Weisel Partners 2007 Healthcare Conference
10. Z Trim Announces Revocation of Gregory Halpern Severence Agreement
11. Brooke Franchise Corporation Announces Selected July Results

Post Your Comments:
*Name:
*Comment:
*Email:
(Date:11/30/2009)... How about a stocking stuffer that saves lives? ...-Reflective POP BANDS® , Pet Collars and Leas...ue, and fun gifts that make a difference. , ..., 2009 -- How would you like to give a gift this h..., , , , ,Vedante,s super-reflective POP BANDS®...
(Date:11/30/2009)... To best serve our patients, their caregivers, a... Institute of Women,s Health of North America in F... This service is available to all individuals (mal...website to locate a convenient LOCATION near you... (Vocus) November 30, 2009 -- According to the mo...
(Date:11/30/2009)... According to Steven McConnell, DDS, teaching yo...season is a good idea, but brushing their teeth co...ming down with a virus. , ...ifornia Dental Hygienists’ Association, it i...al health and flu prevention because the H1N1 viru...
(Date:11/30/2009)... Lawyers from The Healy Law Firm secure the high...ehalf of man rendered an incomplete quadriplegic. ...s) November 30, 2009 -- A Cook County jury has ent...immigrant carpenter, 22 years old at the time, who...omplete quadriplegic. The verdict, which was redu...
(Date:11/30/2009)... Firm uses Staten Island courtroom to recreate s...ere 100% responsible for client’s accident. ...November 30, 2009 -- A Staten Island, N.Y. jury aw...perhanger who was injured at a New York City const...J.T. Magen Construction Company et al (Index No. 1...
Breaking Medicine News(10 mins):Health News:Fun and Fashionable Holiday Gifts that Save Lives 2Health News:Fun and Fashionable Holiday Gifts that Save Lives 3Health News:Fun and Fashionable Holiday Gifts that Save Lives 4Health News:2009 H1N1 Influenza Vaccination Being Offered at Various Affiliated Campuses of the Institute of Women's Health of North America in Florida 2Health News:2009 H1N1 Influenza Vaccination Being Offered at Various Affiliated Campuses of the Institute of Women's Health of North America in Florida 3Health News:Tips on Decreasing Susceptibility to the H1N1 Virus - Optimum Oral Hygiene Can Prevent Flu 2Health News:Tips on Decreasing Susceptibility to the H1N1 Virus - Optimum Oral Hygiene Can Prevent Flu 3Health News:Tips on Decreasing Susceptibility to the H1N1 Virus - Optimum Oral Hygiene Can Prevent Flu 4Health News:Cook County Jury Awards a Gross Verdict of $8.1 Million to Victim of Swimming Pool Accident 2Health News:Cook County Jury Awards a Gross Verdict of $8.1 Million to Victim of Swimming Pool Accident 3Health News:Raphaelson & Levine Secures $1.1 Million Verdict for Victim of New York Construction Accident 2
...he good news: Suicide rates among younger and olde...90s. Now, the puzzling news: No one really knows w...ducted by researchers at the University of South C...ciate dean for research at the University of South...
...Johns Hopkins faculty members performing microsurg...imore operating room, or health care experts// in ...edical students gathered in the Hopkins outpatient...nk Johns Hopkins faculty with clinicians in India....
...ust one salad a day provides even greater health b...udy that examined salad consumption by more than 1...School of Public Health and Louisiana State Univer...ssing have considerably higher levels of vitamins ...
...Americans and Latinos are the segments of the soci...heir last screening programs // like mammogram, Pa...rsity of Rochester finds. Researchers said they we... almost all people will think it's been a shorter ...
...h semester student of the premier All India Instit... of dengue even as authorities // said measures we...er in the campus. Kamal Raj Kiran was admitte...n haemorrhage. "Kiran, a native of Hyderabad...
...iver transplant recipients outlive men given the s... research published ahead of print in Gut. // ... all, they also stand to lose more years of their ...e lost of 2702 people who had received a liver tra...
Other Medicine News:Health News:Most Suicide Rates Decline, but Findings Are Puzzling 2Health News:Most Suicide Rates Decline, but Findings Are Puzzling 3Health News:High-Speed Internet2 Link Revolutionizes Global Medical Education 2Health News:Ethnic Differences in Healthcare 2Health News:AIIMS Student Dies of Dengue Fever 2
(Date:11/30/2009)...wire-FirstCall/ -- , - First New Anti-Arr...in,the Last 10 Years , Sanofi-aventis (EU... the,European Commission has granted marketing aut...ets) in all 27 European member states. This approv...n issued on September 25, 2009,by the Committee fo...
(Date:11/29/2009)...-- Radiologists can accurately diagnose acute appe...handheld device or mobile phone equipped with spec... at the annual meeting of the Radiological Society...mprove the speed and accuracy of medical diagnoses...rent consulting physicians," said the study,s lead...
(Date:11/29/2009)...-- Middle-aged men and women who engage in high le...ng damage to their knees and increasing their risk...d today at the annual meeting of the Radiological ...uggest that people with higher physical activity l...bnormalities and, thus, at higher risk for develop...
Breaking Medicine Technology:Sanofi-aventis: Multaq(R) Approved in the European Union for Patients With Atrial Fibrillation 2Sanofi-aventis: Multaq(R) Approved in the European Union for Patients With Atrial Fibrillation 3Sanofi-aventis: Multaq(R) Approved in the European Union for Patients With Atrial Fibrillation 4Sanofi-aventis: Multaq(R) Approved in the European Union for Patients With Atrial Fibrillation 5Smart Phones Allow Quick Diagnosis of Acute Appendicitis 2Smart Phones Allow Quick Diagnosis of Acute Appendicitis 3Too Much Physical Activity May Lead to Arthritis 2Too Much Physical Activity May Lead to Arthritis 3Dr Lynese Lawson Speaks to Sterling Women 3A Strategies to Rejuvenate Your Health and Your Career 56895 1Dr Lynese Lawson Speaks to Sterling Women 3A Strategies to Rejuvenate Your Health and Your Career 56895 2Dr Lynese Lawson Speaks to Sterling Women 3A Strategies to Rejuvenate Your Health and Your Career 56895 3Flintec Load Cell Design Helps to Create Vital Medical Solutions 56891 1Flintec Load Cell Design Helps to Create Vital Medical Solutions 56891 2Flintec Load Cell Design Helps to Create Vital Medical Solutions 56891 3Flintec Load Cell Design Helps to Create Vital Medical Solutions 56891 4Migrating birds chill to fatten up 9883 1Migrating birds chill to fatten up 9883 2
...reatment gap" between the number of patients world...d the number of organs available, a gap that is,im...a new market research,report from Kalorama Informa... In the US, over 97,000 patients were on the Unit...,000 received a transplant. Other countries,show s...
...al debate over effects of Simvasta...eachMD, an innovative multi-channel,platform for m...io Channel,157 and simulcast via ReachMD Online at...sion on the much talked-about ENHANCE (Effect of C... Simvastatin Alone on the,Atherosclerotic Process ...
Other Medicine Technology:Organ Donor Shortage Remains Obstacle for Would-Be Transplant Patients Despite Better Medicine 2ReachMD Broadcasts First-of-its-Kind Physician Peer-Peer Discussion on ENHANCE Trial 2
...es is a national reference laboratory and a worldw...evelopment. ARUP offers an extensive test menu of ...l and anatomic pathology. Owned by the University ...han half of the nation's university teaching hospi...
...es is a national reference laboratory and a worldw...evelopment. ARUP offers an extensive test menu of ...l and anatomic pathology. Owned by the University ...han half of the nation's university teaching hospi...
...es is a national reference laboratory and a worldw...evelopment. ARUP offers an extensive test menu of ...l and anatomic pathology. Owned by the University ...han half of the nation's university teaching hospi...
...es is a national reference laboratory and a worldw...evelopment. ARUP offers an extensive test menu of ...l and anatomic pathology. Owned by the University ...han half of the nation's university teaching hospi...
Medicine Products: