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:5/10/2017)... Mass., May 10, 2017 Hologic, Inc. (Nasdaq: ... results for the fiscal second quarter ended April 1, ... of $1.84 increased 666.7% compared to the prior year ... resulted in a significant gain, while non-GAAP diluted EPS ... 3.2%, or 3.8% in constant currency terms.  Excluding the ...
(Date:5/10/2017)... Radiology has become the number one diagnostic ... spiraled to the number one ranking as a result.  ... before as the most complete and reliable method for ... back pain an MRI may confirm a suspected herniated ... in entirely different treatment protocols.  In these circumstances, patients ...
(Date:5/9/2017)...  Demonstrating its commitment to representing research- based ... Pharmaceutical Research and Manufacturers of America (PhRMA) today ... now have to meet new research and development ... join PhRMA. "By putting in place ... clear message that being a member of PhRMA ...
Breaking Medicine Technology:
(Date:5/24/2017)... ... May 24, 2017 , ... Dr. Alan I. Benvenisty, ... in New York City. He is known for his distinguished expertise and experience in ... Dr. Benvenisty holds sub-specialty training in treating renovascular disease and aortic aneurysm . ...
(Date:5/24/2017)... (PRWEB) , ... May 24, 2017 , ... Patients who ... Cortland, OH, can now meet with Dr. Joseph Bedich for a consultation, with or ... simultaneously improving their oral health and functionality. , Dr. Bedich offers a ...
(Date:5/24/2017)... ... May 24, 2017 , ... Medic CE , a Career ... about Pediatric Septic Shock” hosted by the Journal of Emergency Medical Services (JEMS). The ... time, will be presented by Captain Rommie Duckworth, LP, a career fire captain as ...
(Date:5/24/2017)... ... May 24, 2017 , ... The CFOs included ... and health systems in the nation and help their organizations navigate the challenges ... and been instrumental in developing successful hospital and health system strategy. , Becker's ...
(Date:5/23/2017)... CA (PRWEB) , ... May 23, 2017 , ... ... financial organizations, today announced CIO Applications magazine has named the company a “Top ... innovative use of the Cloud to help organizations simply and proactively address potential cybersecurity ...
Breaking Medicine News(10 mins):