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:10/11/2017)... 2017  True Health, a leader in integrated ... during National Breast Cancer Awareness month to educate ... Research recently published ... more than 10 million American women are at ... or BRCA2 and have not had testing. These mutations ...
(Date:10/5/2017)... Oct. 5, 2017  In response to the ... and Maxillofacial Surgeons (AAOMS) released prescribing recommendations that ... be used as a first-line therapy to manage ... Recognizing the value and ... Paper "Opioid Prescribing: Acute and Postoperative Pain Management" ...
(Date:10/2/2017)... 2, 2017  Eli Lilly and Company (NYSE: ... the third quarter of 2017 on Tuesday, October 24, ... that day with the investment community and media to ... conference call will begin at 9 a.m. Eastern time. ... live webcast of the conference call through a link ...
Breaking Medicine Technology:
(Date:10/13/2017)... ... October 13, 2017 , ... PurhealthRX , a leading ... Purzorb™ technology. Applying the Purzorb™process to full spectrum CBD oil will revolutionize the rapidly ... CBD form that can be easily incorporated into liquid products, while reducing costs to ...
(Date:10/13/2017)... , ... October 13, 2017 , ... The Visiting Nurse ... Market. Featuring a collection of specialty vendors and unique items from across the nation, ... quality-focused health and wellness services offered by the VNA. The boutique will be ...
(Date:10/13/2017)... VA (PRWEB) , ... October 13, 2017 , ... ... of DevOps and Agile Software Development, has been awarded a contract by the ... Blanket Purchase Agreement (BPA) aims to accelerate the enterprise use of Agile methodologies ...
(Date:10/12/2017)... (PRWEB) , ... October 12, 2017 , ... Planet Fitness, ... the U.S., announced today its plans to open a flagship location in Covington, LA ... the former Rooms To Go store next to Office Depot in the Holiday Square ...
(Date:10/12/2017)... (PRWEB) , ... October 12, 2017 , ... ... drug delivery system that we intend to develop to enable prevention of a ... lead to severe hearing loss, especially in pediatric patients. For cisplatin, hearing loss ...
Breaking Medicine News(10 mins):