Like its flagship Impella device, the Impella RP is threaded to the heart through the femoral artery. But, unlike previous Impella models designed for the heart’s left ventricle, the Impella RP is designed to access the heart’s right ventricle via the vena cava.
"We are proud to announce the commercial European availability of the new Impella RP device," chairman, president & CEO Michael Minogue said in prepared remarks. "This exciting news follows our recent announcement of the completion of patient enrollment in the U.S. [investigational device exemption] Recover Right trial, which further emphasizes the need for percutaneous support for right sided heart failure in hospitals around the world."
Abiomed said the CE Mark indication is for up to 14 days for patients with reduced right ventricular function after cardiotomy, cardiogenic shock after a heart attack with right ventricle failure, cardiac assistance during bypass procedures, right ventricle failure after implantation with a left ventricular assist device, and for certain types of arrhythmia.
Last month Abiomed said it would ask the FDA to let it expand a U.S. clinical trial for the Impella RP, having met its 30-patient initial enrollment goal.
The Danvers, Mass.-based medical device company won the IDE from the FDA for the Recover Right trial in 2012, implanting the 1st patient in the spring of 2013. To be eligible for the 2-year study, patients must either develop right-side heart failure within 48 hours after LVAD implantation, after going into shock within 48 hours of heart surgery or after a heart attack.
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