RICHMOND, Va. (Sept. 9, 2010) The Virginia Commonwealth University Medical Center is the lead institution in a national clinical trial of technology that will allow artificial heart patients to recuperate, rehabilitate and wait in the comfort of their own homes until a donor heart becomes available for transplant.
The VCU Pauley Heart Center is one of up to 30 centers that will investigate a portable, mechanical driver that can power patients' artificial hearts and enable them to recover outside the hospital environment, including at home and at step-down facilities.
"This is the kind of technology that changes lives," said John Duval, CEO of MCV Hospitals at the VCU Medical Center. "VCU has long been a leader in heart-assist technology, pioneering the implantation of the first Total Artificial Heart on the East Coast in 2006.
"This portable driver, if successful, will allow patients who once had to spend months, and sometimes more than a year in the hospital waiting for a donor heart, to recuperate in the comfort of their own homes," Duval said.
The VCU Medical Center received institutional review board approval in early September to participate in an Investigational Device Exemption (IDE) clinical study of the Freedom driver, the first-ever U.S. portable driver designed to power SynCardia's Total Artificial Heart both inside and outside the hospital. The IDE clinical study is intended to demonstrate that the Freedom driver is a suitable pneumatic driver for stable Total Artificial Heart patients and can be used safely at home.
"Prior to this, everyone who was placed on a Total Artificial Heart had to remain in the hospital until they underwent transplantation," said Michael Hess, M.D., director of the VCU Pauley Heart Center advanced heart failure transplantation program. "The reason for this is that the only FDA-approved driver system for powering the Total Artificial Heart is a 418-pound console.
|Contact: Anne Buckley|
Virginia Commonwealth University