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)... -- MiMedx Group, Inc. (NASDAQ: MDXG ), the leading ... birth tissues, human skin and bone, and patent-protected processes ... and therapies, announced today that it will present at ... New York , NY.  Parker H. ... , Chief Financial Officer and Chris Cashman , ...
(Date:2/11/2016)... WESTPORT, Conn. , Feb. 11, 2016  AfterPill.com ... decision to recommend alcohol abstinence for all women who ... women in the U.S. each year and raises the ... --> --> According to the ... U.S., 70% of women of child-bearing age, who have ...
(Date:2/11/2016)... Feb. 11, 2016 Wearable posture tracker, ALEX , has taken Kickstarter by storm, crowdfunding ... seven days left to go, ALEX is said to be delivered to backers starting May of this ... ... ... Created by NAMU, a ...
Breaking Medicine Technology:
(Date:2/14/2016)... ... February 14, 2016 , ... In ... Heart Failure Nurses (AAHFN) is promoting healthier living with heart failure by providing ... Life! Healthy Living with Heart Failure will kick-off February 14 and includes tips ...
(Date:2/13/2016)... (PRWEB) , ... February 13, 2016 , ... Many individuals ... of protein for a multitude of reasons. IsoPasta by Isolator Fitness has delved ... it once more, but without the high-carb repercussions. IsoPasta has 30 grams of ...
(Date:2/13/2016)... ... ... an Au Pair comes all the way around the world to provide child ... are often worried things won’t go well. More often than not, however, they find out ... the Year winner’s all commented how their Au Pairs have become a part of the ...
(Date:2/12/2016)... ... February 12, 2016 , ... The law firm of Morrow, Morrow, Ryan & ... purpose of these scholarships is to encourage applicants to pursue a degree in their ... these two parishes. , “We have available jobs in St. Landry and Evangeline ...
(Date:2/12/2016)... ... February 12, 2016 , ... Each year, the American Physical Therapy ... Anaheim, CA at the Anaheim Convention Center. Almost 10,000 physical therapists across the country ... in action, learn more about their chosen field and network with their colleagues. ...
Breaking Medicine News(10 mins):