U of M Leading Center in FDA Approval of New Generation of Health Device

MINNEAPOLIS/ST.PAUL (June 30, 2008) – The University of Minnesota Medical Center, Fairview was among the leading centers in implanting the HeartMate II ®, a next-generation left ventricular assist device (LVAD) which was recently approved by the Federal Drug Administration (FDA) as a bridge to transplant.

Researchers, including those at the University of Minnesota published the data regarding the success of this device in the New England Journal of Medicine in August 2007.

The HeartMate II® LVAD is a mechanical circulatory support device intended for advanced-stage heart failure patients. The device is connected to the heart and the blood is drained from the weakened left ventricle into the pump, where an axial flow motor ejects blood into the ascending aorta through a graft. This pump is designed to take over the pumping ability of the weakened left ventricle and cover the full output of a healthy heart. It is much quieter, smaller and more durable than previous LVADs. The motor is the only moving part in this device and it runs continuously on ruby bearings that are lubricated by the steady flow of blood.

“The remarkable success for patients who received the HeartMate II® LVAD clearly shows that we are in a bright and promising new era of options for patients with end-stage heart failure. Patients had much improved outcomes with significantly reduced complications, said Ranjit John, M.D., principal investigator of the HeartMate II® trial, surgical co-director of the Ventricular Assist Device Program at the University of Minnesota and assistant professor of cardiothoracic surgery. 

Although the FDA has only approved this device as a bridge to transplant, surgeons are also collecting data on the use of the HeartMate II® for destination therapy for patients not eligible for transplant as a result of advanced age and other factors. Early clinical evidence suggests very good outcomes for this population, but a two-year follow-up is required for FDA approval. 

“The mechanical support program, directed by Drs. John, Lyle Joyce, and Andrew Boyle at the University of Minnesota, is among the leaders in the world. These and other innovative therapies available at the University of Minnesota are improving the quality of life for patients with heart failure,” said Daniel Garry, M.D., Ph.D., director of the Lillehei Heart Institute and chief of the division of cardiology at the University of Minnesota.

The clinical trial was funded by Thoratec and individual insurance companies.

The Academic Health Center is home to the University of Minnesota’s six health professional schools and colleges as well as several health-related centers and institutes. Founded in 1851, the University is one of the oldest and largest land grant institutions in the country. The AHC prepares the new health professionals who improve the health of communities, discover and deliver new treatments and cures, and strengthen the health economy.

Contact: Nick Hanson, Academic Health Center, 612-624-2449, hans2853@umn.edu
Molly Portz, Academic Health Center, 612-625-2640, mportz@umn.edu