St Jude Medical announces CE mark approval for the HeartMate 3 Left Ventricular Assist System

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St Jude Medical has announced that it has received CE mark approval for the HeartMate 3 Left Ventricular Assist System (LVAS). This is a cardiac support option for advanced heart failure patients awaiting transplantation who are not candidates for heart transplantation, or in myocardial recovery.

“The advanced heart failure medical community has eagerly anticipated the expected clinical improvements with the HeartMate 3 system and looks forward to its broad adoption throughout Europe,” says Friedhelm Beyersdorf, Medical Director, Department of Cardiovascular Surgery, Heart Center Freiburg University, Germany.

The HeartMate 3 system is the first commercially approved centrifugal-flow left ventricular assist device (LVAD) utilising 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.

 

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% six-month survival rate; which according to a company releae, is the best six-month survival rate to date to be documented in an LVAD CE mark clinical study. St Jude Medical expects a limited market release across Europe to begin immediately, with additional market releases taking place throughout 2016.

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

 

The Heartmate 3 CE mark clinical trial, which concluded in November 2014, enrolled 50 patients at 10 hospitals in six countries outside the USA. Enrolment included both bridge-to-transplant and destination therapy patients in New York Hospital Association Class IIIb or IV heart failure. In the USA, the HeartMate 3 system is in an ongoing IDE trial. The MOMENTUM 3 IDE trial, the largest of its kind, remains ongoing and will enrol more than 1,000 patients.

 

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