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The FDA approved the Impella RP device for percutaneous, temporary assist of the right ventricle, Abiomed .
Its specific indication is for use up to 14 days in patients with body surface area of at least 1.5 m2, who develop acute right heart failure or decompensation after left ventricular assist device implantation, myocardial infarction, heart transplant, or open-heart surgery.
A humanitarian device exemption was previously granted for Impella RP. The full approval was based on the prospective, multicenter, single-arm , with a 73.3% 30-day survival rate in patients who developed right heart failure within 48 hours of implantation of a left ventricular assist device or who developed it within 48 hours of developing shock post-cardiotomy or post-acute myocardial infarction.
Abiomed said it will complete a post-approval study with 60 consecutive patients in the firm's FDA-audited prospective cVAD Registry.