The FDA has granted approval to Thoratec’s HeartMate II, a continuous-flow, left ventricular assist device (LVAD), for its use in heart failure patients who are not candidates for a heart transplant.
The HeartMate II is a lightweight blood pump that is implanted in a patient’s chest and powered by an electrical cable that allows the pump to pass through a patient’s skin to an external control located around the patient’s waist, according to the agency. In addition, the device is equipped with an alarm that alerts the patient of device malfunction or changes that could impact pump operation.
The device was previously indicated by the FDA for its use in patients awaiting transplants or further heart treatment only.
“The approval of HeartMate II provides an option for heart failure patients who cannot receive a transplant,” said Jeffrey Shuren, MD, 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.”
The current FDA approval is based on a clinical study of 200 patients implanted with the HeartMate II LVAD device. After two years, results found that 46 percent of the 134 patients implanted with the device survived and had no signs of stroke or need for device replacement, compared to 11 percent of the control group.
In accordance with the FDA, the Pleasanton, Calif.-based company will conduct a post-approval study to evaluate the device's efficacy. Results will be recorded and made public in the FDA's Interagency Registry of Mechanical Assisted Circulatory Support (INTERMACS) registry after the study’s conclusion.