Navigation Links
DuraHeart(TM) LVAS Receives Conditional Approval for US Pivotal Trial
Date:3/3/2008

ANN ARBOR, Mich., March 3 /PRNewswire/ -- Terumo Heart, Inc. announced today that they have received conditional approval from the Food and Drug Administration (FDA) to begin enrollment in the US Pivotal Trial of the DuraHeart (TM) LVAS for a Bridge-to-Transplant (BTT) indication.

(Logo: http://www.newscom.com/cgi-bin/prnh/20070227/CLTU043LOGO )

(Photo: http://www.newscom.com/cgi-bin/prnh/20080303/CLM012 )

Dr. David Munjal, Vice President of Clinical Studies, Regulatory Affairs and Quality Systems at Terumo Heart, Inc., commented: "We are extremely pleased that FDA has allowed us to move directly to the Pivotal Trial based on our existing European data. The conditional approval was granted pending answers to some additional questions. Terumo Heart, Inc. has already responded to the FDA concerning these questions and final approval is anticipated in the near future."

Dr. Chisato Nojiri, M.D., Ph.D., Chief Executive Officer for Terumo Heart, Inc., said: "The approval of the IDE Pivotal Trial is a major milestone for Terumo Heart and we are especially pleased that the FDA has also issued approval for patients to be discharged home. This positive decision by the FDA was based on our robust preclinical data and the successful European clinical trial of the DuraHeart System."

The Pivotal Trial will be a multi-center, prospective, non-randomized study of 140 patients and will include up to 40 centers. The Principal Investigators will be Francis Pagani, M.D., Ph.D., from the University of Michigan and Yoshifumi Naka, M.D., Ph.D., from Columbia Presbyterian Hospital in New York.

The DuraHeart LVAS is a third generation circulatory support device intended to provide cardiac support for patients who are at risk of death due to end-stage left ventricular failure. It is currently the only CE marked implantable LVAS combining a centrifugal pump with magnetic levitation of the impeller, providing exceptional reliability and minimizing the potential for blood damage and thrombus. The DuraHeart LVAS is not available for sale in the United States.

Terumo Heart, Inc. is a US subsidiary of Terumo Corporation with headquarters and manufacturing facilities in Ann Arbor, Michigan. The company's focus is the innovation and introduction of products to improve the quality of healthcare for heart failure patients. Terumo Corporation, located in Tokyo, Japan, is a leading developer, manufacturer and global marketer of a wide array of medical products.

For more information, please contact Mark White, Marketing Manager, Terumo Heart, Inc. at (734) 741-6262 or mark.white@terumomedical.com.


'/>"/>
SOURCE Terumo Heart, Inc.
Copyright©2008 PR Newswire.
All rights reserved

Related medicine technology :

1. Terumo Heart Reports Summary of DuraHeart(TM) LVAS Clinical Trial Results
2. Terumo Heart to Announce Results of European Clinical Trial of DuraHeart(TM) LVAS at European Association of Cardiothoracic Surgeons Meeting in September
3. Vermillion Receives Award From the Society of Gynecologic Oncologists
4. Arbios Receives Conditional Approval from the FDA to Initiate Pivotal Clinical Trial for SEPET(TM)
5. ActivBiotics Receives Orphan Drug Designation from the European Medicines Agency for Superoxide Dismutase Mimetic, M40403, in Oral Mucositis Indication
6. Thalidomide Pharmion(R) Receives Positive Opinion for Treatment of First-line Multiple Myeloma from European Medicines Agency
7. Peregrine Pharmaceuticals Receives Approval to Conduct a Second Phase II Trial of Bavituximab in Patients With Advanced Breast Cancer
8. Photo: Welchol(TM) (colesevelam HCl) Receives FDA Approval to Reduce Blood Glucose in Adults with Type 2 Diabetes
9. Peregrine Pharmaceuticals Receives Approval to Conduct a Phase II Trial of Bavituximab in Patients With Non-Small Cell Lung Cancer
10. Abbotts HUMIRA(R) (adalimumab) Receives FDA Approval For Moderate to Severe Chronic Plaque Psoriasis
11. Vical Receives Payment from AnGes MG for Allovectin-7(R) Phase 3 Pivotal Trial
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:2/11/2016)... 11, 2016 Stem cells are primitive cells ... self-renewal and the capacity to differentiate into mature cell ... as the first mouse embryonic stem cells were derived ... 1995 that the first culturing of embryonic stem cells ... not produced until 2006 As a result of these ...
(Date:2/11/2016)... 2016  Walgreens has committed to provide drug disposal ... Washington, D.C. as part of a program ... by shareholder advocacy organization As You Sow. Conrad ... people hold on to unneeded drugs because they lack easily ... --> Conrad MacKerron , Senior Vice President ...
(Date:2/11/2016)... Feb. 11, 2016  NOIT™ Research LLC, a private, ... of Change" campaign to assist needy families in obtaining ... unit sold between February 10, 2016 and March 31, ... needy family. The NOIT is an auditory stimulus that ... develop language skills. Beth Shier , ...
Breaking Medicine Technology:
(Date:2/12/2016)... ... February 12, 2016 , ... Coco Libre, the maker of coconut water beverages ... GRAMMY’s Style Lounge Event. Coco Libre will offer musicians and celebrities the company’s signature ... event. The invitation-only gifting suite, held this year at the W Hollywood Hotel, has ...
(Date:2/12/2016)... ... February 12, 2016 , ... The ThedaCare ... San Francisco General Hospital on April 5-7. The series is a multi-day, multi-workshop ... habits. The workshops cover a broad range of topics, including coaching skills, the ...
(Date:2/12/2016)... PITTSBURGH, Pa. (PRWEB) , ... February 12, 2016 , ... ... space heaters. , This winter the West Penn Burn Center, part of ... Fire Company #1, to bring you the “Space Heaters Need Space” campaign. ...
(Date:2/12/2016)... ... ... AssureVest Insurance Group, a locally owned insurance firm with offices serving Washington NC ... to purchase computers and software for Mrs. Harrison’s 2nd and 3rd grade special needs ... area and has more than 60 2nd and 3rd graders with learning disabilities. A ...
(Date:2/12/2016)... Vail, Colorado (PRWEB) , ... February 12, 2016 , ... ... 164 ASC Industry Physician Leaders to Know in 2016 . The list consists of ... leaders nominated physicians to establish this list. , An Ambulatory Surgery Center, also ...
Breaking Medicine News(10 mins):