Navigation Links
First DuraHeart(TM) Left Ventricular Assist System Implanted in the U.S. Pivotal Trial

ANN ARBOR, Mich., Aug. 6 /PRNewswire/ -- Terumo Heart, Inc. announced that the first U.S. implant of the DuraHeart(TM) Left Ventricular Assist System (LVAS) took place on July 30 at the University of Michigan Cardiovascular Center in Ann Arbor, Michigan. The surgery was performed by Francis Pagani, M.D., Ph.D. National Co-Principal Investigator for the DuraHeart U.S. Pivotal Trial. DuraHeart is the world's first third generation left ventricular assist system combining a centrifugal pump with a magnetically levitated impeller to enter clinical trials in the U.S.

"The DuraHeart gives us a new, third-generation option for patients with advanced heart failure who need help to allow them to survive until they can receive a heart transplant," says Pagani, who leads the U-M Center for Circulatory Support.

Chisato Nojiri, M.D., Ph.D., Chief Executive Officer for Terumo Heart, Inc., said, "The first patient in the United States is an important initial step in the pivotal trial. This patient is the 71st patient worldwide since the DuraHeart European investigational trials began in 2004. We have had exceptional outcomes in Europe and look forward to similar outcomes in the U.S." In clinical results as of July 31, 2008, patient support averaged 223 days with cumulative support of 43 years. The longest ongoing patient support is over three years.

The DuraHeart LVAS Pivotal Trial is a multi-center, prospective, non- randomized study of 140 patients and will include up to 40 centers. The device is intended to provide cardiac support for patients awaiting transplant who are at risk of death due to end-stage left ventricular heart failure. Yoshifumi Naka, M.D., Ph.D., from Columbia Presbyterian Hospital in New York, will serve as the National Co-Principal Investigator with Dr. Pagani.

Dr. Nojiri added, "We are excited at the prospect of making this state of the art technology readily available for the increasing need of heart failure patients. Third generation systems are anticipated to demonstrate improved outcomes and long term reliability. DuraHeart is the most advanced third generation centrifugal pump by virtue of the magnetically levitated impeller, positioning us for a leadership role in the future treatment of heart failure." In addition to the U.S. trial, Terumo Heart is expected to initiate clinical trials in Japan this year.

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, headquartered in Tokyo, Japan, is a leading developer, manufacturer and global marketer of a wide array of medical products. DuraHeart is limited to investigational use only in the United States, and is CE marked in Europe.

SOURCE Terumo Heart, Inc.
Copyright©2008 PR Newswire.
All rights reserved

Related medicine technology :

1. First U.S. Patient to Receive New Heart-Assist Device Doing Well After Surgery at University of Michigan
2. MicroDose Technologies Announces Achievement of Phase I Clinical Milestone Triggering First Milestone Payment Under Collaboration with Merck & Co., Inc.
3. First Molecular Tem-PCR Test to Identify Multiple Forms of Staph and MRSA Obtains CLIA Certificate
4. Sanofi Pasteur Shipping First Doses of Influenza Vaccine for the 2008-2009 Season in the US
5. First Ever Study on Alzheimers Disease Treatment in Hispanics Presented at Major Medical Meeting
6. Seattles Swedish Cancer Institute First in U.S. to Treat Cancer Patient with Elekta VMAT
7. Quark Pharmaceuticals Announces First Patient Dosing by Pfizer in Phase II Trial of RNAi Therapy in Diabetic Macular Edema
8. BRIDION(R) (sugammadex) Injection - First and Only Selective Relaxant Binding Agent - Approved in European Union
9. Novare Announces Completion of First Pediatric Single Port Spleen Removal Using RealHand(R) HD Instruments
10. First Cancer Diagnostic Test Based on Rosetta Genomics Proprietary MicroRNA Technology Receives Regulatory Approval
11. Ekkyo Describes the First Benefits of Controlled Hyperthermia in Humans in "Lasers in Surgery and Medicine"
Post Your Comments:
(Date:11/26/2015)... , November 26, 2015 3D ... by 2022, according to a new report by Grand View ... Kidney Disease (CKD) which demands kidney transplantation is expected to ... cost effective substitute for organ transplantation. --> 3D ... by 2022, according to a new report by Grand View ...
(Date:11/26/2015)... November 26, 2015 ... the "2016 Future Horizons and Growth ... Testing Market: Supplier Shares, Country Segment Forecasts, ... their offering. --> ) ... "2016 Future Horizons and Growth Strategies in ...
(Date:11/26/2015)... November 26, 2015 ... adds "Global Repaglinide Industry ... Report on China Repaglinide Market, 2010-2019" ... data and information to its online ... . --> ...
Breaking Medicine Technology:
(Date:11/25/2015)... ... 2015 , ... Beddit® has launched a new Android app for ... features a more intuitive SleepScore™ that rates sleep quality on a 100-point scale and ... created by a proprietary algorithm. Beddit analyzes the data to provide an easy to ...
(Date:11/25/2015)... (PRWEB) , ... November 25, 2015 , ... In an ... Resurrection Medical Center (RMC) in Chicago, IL, UV Angel is evaluating the efficacy of ... and surgical intensive care units (totaling 30 beds) from May 2014 through October 2015 ...
(Date:11/25/2015)... ... ... Today, Mothers Against Drunk Driving (MADD) learned that the number of ... time since 2011. In 2014, there were 9,967 fatalities involving an alcohol impaired driver, ... Traffic Safety Administration (NHTSA), 32,675 people were killed in traffic crashes in 2014. Drunk ...
(Date:11/25/2015)... Silver Spring, Md (PRWEB) , ... November 25, ... ... the Pulmonary Hypertension Association (PHA) announces the nation’s Periwinkle Pioneers, individuals and groups ... the history of this disease. The Periwinkle Pioneers, nominated by the public, will ...
(Date:11/25/2015)... , ... November 25, 2015 , ... ... announced that it has undertaken significant expansion of its current state of the ... is part of PharmaTech’s strategy to increase its manufacturing capacity as well as ...
Breaking Medicine News(10 mins):