FDA Approves Left Ventricular Assist System for Severe Heart Failure Patients
Device Provides Support for Those Who Are Not Acceptable Transplant Candidates
The U.S. Food and Drug Administration today approved the HeartMate II, a continuous-flow, left ventricular assist system as a support for severe heart failure patients who are not acceptable candidates for heart transplantation.
The HeartMate II is already FDA-approved for use in patients awaiting further, perhaps more complex treatment, such as transplants.
Heart assist devices are surgically implanted mechanical pumps that help the heart's ventricle pump blood to the rest of the body. 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."