Navigation Links
Terumo Heart Obtains IRB Approval from the University of Michigan to Initiate DuraHeart(TM) Left Ventricular Assist System U.S. Pivotal Trial
Date:6/25/2008

ANN ARBOR, Mich., June 25 /PRNewswire/ -- Terumo Heart, Inc. announced today approval from the Institutional Review Board (IRB) at the University of Michigan to move forward with the DuraHeart(TM) Left Ventricular Assist System (LVAS) U.S. Pivotal Trial for a Bridge-to-Transplant (BTT) indication. Francis Pagani, M.D., Ph.D., Director of the Adult Heart Transplantation and Artificial Devices Program at the University of Michigan, will serve as the National Co-Principal Investigator of the U.S. Pivotal Trial.

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

The University of Michigan IRB approval is the final step to initiate the DuraHeart LVAS U.S. Pivotal Trial following the completion of staff training and equipment delivery. The University of Michigan also serves as the primary training site for the U.S. Trial.

Chisato Nojiri, M.D., Ph.D., Chief Executive Officer for Terumo Heart, Inc., said, "With the IRB approval, DuraHeart LVAS will be the first third-generation centrifugal pump with magnetic levitation under investigation in the U.S. We look forward to working with Dr. Pagani and his team on the U.S. Pivotal Trial."

The DuraHeart LVAS Pivotal Trial is a multi-center, prospective, non-randomized study of 140 patients and will include up to 40 centers. Yoshifumi Naka, M.D., Ph.D., from Columbia Presbyterian Hospital in New York, will serve as the National Co-Principal Investigator with Dr. Pagani.

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 U.S. 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 Carmen Fox, Senior Marketing Communications Specialist, Terumo Heart, Inc. at (734) 741-6345 or carmen.fox@terumomedical.com.

http://www.terumoheart.com


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

Related medicine technology :

1. Terumo Heart to Announce Results of European Clinical Trial of DuraHeart(TM) LVAS at European Association of Cardiothoracic Surgeons Meeting in September
2. Terumo Heart Reports Summary of DuraHeart(TM) LVAS Clinical Trial Results
3. Terumo Heart Summarizes Results of DuraHeart(TM) LVAS Implants
4. Many Heart Attack Patients Dont Get Best Emergency Treatment
5. The Heart, Diabetes, And Weight Loss Centers of New York Introduce the New Science of Metabolic Diagnosis and Weight Management
6. American Heart Association Comment Saving Lives in Type 2 Diabetics: Could It Be as Easy as Lowering Blood Pressure?
7. WorldHeart Announces Further Milestone in Miniaturized Assist Pump Development
8. CellCyte Genetics Corp. Enters Collaborative Research Agreement With Cleveland Clinic Foundation to Qualify Stem Cell Delivery in Damaged Heart Tissue
9. Its Only Heartburn...or is it? Chronic Heartburn a Risk Factor for Precursor to Esophageal Cancer
10. Cleveland Clinic Study Shows the Diabetes Drug Pioglitazone Reduces Risk of Death, Heart Attack and Stroke, but Increases Risk of Heart Failure
11. Hypertension: Journal of the American Heart Association Rapid Access Reports: Hispanics Hypertension Better Controlled With Equal Access to Care
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:8/15/2017)... 15, 2017   Mostyn Law and Gulf Coast Regional ... Texas . The Mostyn Law family has had ... That is why Mostyn Law is partnering with Gulf ... show its appreciation. Blood supplies are running low. Gulf ... of hospital needs in August. That is why the blood center ...
(Date:8/15/2017)... Inc., the creator of the drug Truveta for the treatment ... IPO. The United States spends approximately ... prescription epilepsy drug being $450.00-$1200.00 for a one month supply. ... AXIUM PHARMACEUTICALS, INC ... is the fact that Americans spent $42 billion on anxiety medications last ...
(Date:8/15/2017)... Aug. 15, 2017  AOTI Inc. announced today that its fully ... has recently opened a New York City Office in ... its unique Topical Wound Oxygen (TWO 2 ) homecare therapy. This ... Commission for Health Care (ACHC) under the company,s DMEPOS accreditation for ... ...
Breaking Medicine Technology:
(Date:8/18/2017)... ... 19, 2017 , ... Mr. Noppadon Pakprot, Deputy Governor for ... Health and Wellness Tourism Showcase 2017 yesterday, which unveiled the latest “Functional & ... Products and Business at TAT said, “Thailand has long been recognized as a ...
(Date:8/18/2017)... New York, New York (PRWEB) , ... ... ... Q International Courier, LLC, d/b/a Quick International, LLC (“Quick”), a highly specialized ... today announced it has entered into a definitive agreement to purchase Unitrans ...
(Date:8/18/2017)... NY (PRWEB) , ... August 18, 2017 , ... ... of “Vision & Hearing” campaign, advocating for active, healthy lifestyles and highlighting the ... available for individuals with hearing impairments and shares the latest innovations in hearing ...
(Date:8/18/2017)... ... 2017 , ... Hernandez Insurance Agencies, a northern Virginia firm ... DC region, is inaugurating a “New Leash On Life” charity initiative in conjunction ... to be companions for veterans in need. , The Semper K9 organization works ...
(Date:8/18/2017)... ... August 18, 2017 , ... MLM Insurance Group, ... communities throughout southern Florida, is working to support the Take Stock In Children ... low income families. , The Take Stock In Children Foundation (TSC) offers guidance ...
Breaking Medicine News(10 mins):