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Home Industry News St Jude Medical receives EU approval for HeartMate 3 Left Ventricular Assist System

St Jude Medical receives EU approval for HeartMate 3 Left Ventricular Assist System

20th October 2015

St Jude Medical has announced that its HeartMate 3 Left Ventricular Assist System has been granted European CE Mark approval.

This cardiac support option is designed for advanced heart failure patients who are awaiting transplantation, are not candidates for heart transplantation, or are in myocardial recovery.

It is the first commercially approved centrifugal-flow left ventricular assist device utilising Full MagLev technology, which allows the device's rotor to be suspended by magnetic forces, thus reducing trauma to blood passing through the pump and improving outcomes.

Data from the HeartMate 3 CE Mark clinical trial showed the device was able to meet its primary endpoint, demonstrating a 92 percent six-month survival rate.

Dr Eric Fain, group president at St Jude Medical, said: "Heart failure remains one of the most costly epidemic diseases in the world, and the HeartMate 3 system is critical to supporting physicians managing the care of patients battling such a complex and challenging condition."

This comes after the firm received CE Mark approval for its Infinity deep brain stimulation system and directional lead last month.ADNFCR-8000103-ID-801803601-ADNFCR

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