Terumo Heart, Inc., an Ann Arbor, Michigan subsidiary of Tokyo’s Terumo Corporation, is happy to announce the first US implantation of its DuraHeart™ Left Ventricular Assist System (LVAS) in a 62 year old male at the University of Michigan, who was subsequently discharged about two weeks later. The device is being trialed as a bridge-transplantion medical device, the typical indication for LVADs. Except for an interesting centrifugal flow rotary pump with a magnetically levitated impeller, the device, its components, and its surgical anastomoses seem to be similar to other “typical” LVADs.
From a press statement by Terumo:
Earlier generation Left Ventricular Assist devices are prone to hemolysis, blood clots and mechanical failure. Significant advances have been made in the DuraHeart LVAS to potentially overcome these problems. Dr. Nojiri explained: “We have a unique pump design that combines advanced “Mag-Lev” technology and a centrifugal pump. The “Mag-Lev” allows for the complete elimination of mechanical contact within the blood flow path, minimizing the chance of mechanical failure. This is expected to significantly improve the clinical performance and long-term potential of this type of therapy.” It has been used in more than 70 patients in Europe with the longest ongoing support over 3 years.
The DuraHeart Bridge-to-Transplant 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 failure. The National Co-Principal Investigators are 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.
Features from the device page:
* Flow rate from two to eight liters per minute with motor speeds between twelve hundred and twenty-four hundred RPM
* Secondary hydrodynamic suspension
* Flow rate that varies with physiological changes
* Silent pump operation
* An advanced Vascutek GelWeave™ outflow graft
* Multiple inflow options for optimal fit
* Thin flexible percutaneous cable
Press release: August 21, 2008: Discharge of First U.S. DuraHeart(TM) Patient
Press release: August 6, 2008: First DuraHeart™ Left Ventricular Assist System Implanted in the U.S.Pivotal Trial
Device page: DuraHeart System