St. Jude Medical's HeartMate 3 LVAS Receives CE Mark Approval

October 12, 2015—St. Jude Medical, Inc. announced European CE Mark approval for the company’s HeartMate 3 left ventricular assist system (LVAS), a cardiac support option for advanced heart failure patients who are awaiting transplantation, not candidates for heart transplantation, or in myocardial recovery. St. Jude Medical expects a limited market release across Europe to begin immediately, with additional market releases taking place throughout 2016.

According to St. Jude Medical, the HeartMate 3 system is a centrifugal-flow left ventricular assist device utilizing the company’s Full MagLev fully magnetically levitated technology, which allows the device’s rotor to be suspended by magnetic forces. This design aims to reduce trauma to blood passing through the pump and improve outcomes for patients. The device is implanted above the diaphragm, immediately next to the native heart, and is attached to the aorta, leaving natural circulation in place while providing all of the energy necessary to propel blood throughout the body.

The HeartMate 3 LVAS includes large, consistent blood flow gaps over a wide range of device operation levels, which is designed to reduce blood trauma. The artificial pulse technology further reduces adverse patient events, including combatting the formation of thrombus in the device.

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% survival rate at 6 months, as well as overall adverse event rates that were either lower or consistent with expectations for severely ill and complex patients requiring LVAS support. 

The trial, which concluded in November 2014, enrolled 50 patients at 10 hospitals in six countries outside the United States. Enrollment included both bridge-to-transplant and destination therapy patients in the New York Hospital Association, class IIIb or IV heart failure. Results from the HeartMate 3 CE Mark trial were presented on September 29 at HFSA 2015, the 19th annual scientific meeting of the Heart Failure Society of America in Washington, DC.

In the United States, the HeartMate 3 system is being evaluated in the ongoing MOMENTUM 3 investigational device exemption trial that will enroll more than 1,000 patients.

On October 8, St. Jude Medical announced the completion of its acquisition of Thoratec Corporation, developer of the HeartMate line of devices.