St. Jude Medical landed European regulatory approval to introduce the HeartMate III left ventricular assist device for patients with heart failure that are waiting for a transplant, are not eligible to receive a transplanted heart, or those undergoing myocardial recovery. It’s capable of moving up to an impressive 10 liters of blood per minute.
Originally developed by Thoratec before the firm was purchased by St. Jude Medical, the system features a magnetically levitated pump rotor that doesn’t make any contact with any other part of the system. This prevents damage to passing blood cells and hopefully reduces the chance of a clot forming due to the pumping mechanism.
The device is attached directly to the aorta and can provide all the energy needed to circulate blood around the body. Unlike other left ventricular assist devices, the HeartMate III actually matches its pumping action to the natural heartbeat of the patient. This makes the blood flow more natural and should also help avoid clot formation.
From the announcement:
CE Mark approval for the HeartMate 3 system was based on data from the HeartMate 3 CE Mark clinical trial, which met its primary endpoint and demonstrated a 92 percent six month survival rate; the best six month survival rate to date to be documented in an LVAD CE Mark clinical study.
The HeartMate 3 CE Mark clinical trial, which concluded in November 2014, enrolled 50 patients at 10 hospitals in six countries outside the U.S. Enrollment included both bridge-to-transplant and destination therapy patients in New York Hospital Association Class IIIb or IV heart failure. The study met its primary endpoint by demonstrating a six month survival rate of 92 percent with the HeartMate 3 LVAS, as well as overall adverse event rates that were either lower or consistent with expectations for severely ill and complex patients requiring LVAD support. In the U.S., the HeartMate 3 system is in an ongoing IDE trial. The MOMENTUM 3 IDE trial, the largest of its kind, remains ongoing and will enroll more than 1,000 patients.
Product page: HeartMate III…
Press release: St. Jude Medical…