The FDA has just issued clearance for Thoratec Corporation‘s HeartMate II LVAD (left ventricular assist device) to be used as a permanent therapy in patients with severe heart failure that are not candidates for organ replacement. The system has garnered FDA’s approval in April of 2008 as a bridge to transplantation, a typical indication for LVADs. By issuing this latest verdict, the first its kind, FDA is now taking the LVAD industry (and cardiac surgery) to a completely new, larger, and potentially more lucrative market.
From a statement by the FDA:
HeartMate II consists of a small, lightweight blood pump implanted in a patient’s chest just below the heart. An electrical cable that powers the blood pump passes through the patient’s skin to an external controller worn around the patient’s waist.
A physician designates the pump’s speed based upon clinical need. The device is designed to sound an alarm upon malfunction or other potentially drastic changes that could impact the pump’s operation.
“The approval of HeartMate II provides an option for heart failure patients who cannot receive a transplant,” said Jeffrey Shuren, M.D., director of the FDA’s Center for Devices and Radiological Health. “Its smaller size and mobility should allow more patients, including women and men of smaller stature, access to treatment.”
In a randomized clinical study of 200 participants at 38 centers, 46 percent of 134 participants with the HeartMate II were still living after two years with no disabling stroke or need for a reoperation for device replacement or repair compared with 11 percent of 66 participants in the control group. In addition, data collected in a separate registry of smaller stature women and men indicated that the device worked well in this specific population.
As a condition of the FDA’s approval, the company will conduct a post-approval study to further evaluate the device’s performance.
FDA press release: FDA Approves Left Ventricular Assist System for Severe Heart Failure Patients…
Product page: HeartMate II…
Flashbacks: FDA Approves Thoratec Heart Pump; HeartMate II Shown Effective In Waiting Transplant Candidates; Canadian Receives HeartMate II Non-Pulsatile LVAD, Eh?; HeartMate® II Left Ventricular Assist System
(hat tip: MassDevice)