Abiomed (NSDQ:ABMD) today said the FDA approved a humanitarian device exemption for its Impella RP heart pump, calling the device the 1st FDA-approved percutaneous, single-access pump for supporting the heart’s right ventricle.
Like Abiomed’s flagship Impella heart pump, the Impella RP is threaded into the heart via the femoral artery in the thigh. But unlike previous Impella models, all designed for the heart’s left ventricle, the Impella RP is designed to access the heart’s right ventricle via the vena cava.
Danvers, Mass.-based Abiomed said the FDA approved the device for 14 days of circulatory assistance in pediatric or adult patients who develop acute right heart failure or decompensation following left ventricular assist device implantation, myocardial infarction, heart transplant or open heart surgery.
"The Impella RP represents a huge step forward in offering right side support using a minimally invasive platform and has the potential to transform interventional cardiology and cardiac surgery today. With the ability to place this device percutaneously on the right side, physicians can now treat acute right sided heart failure minimally invasively and quickly," Dr. Mark Anderson, co-principal investigator of Abiomed’s Recover Right trial, said in prepared remarks.
Abiomed said it’s planning a "controlled launch" of the Impella RP in the U.S. after it provides "rigorous" in-house training for each site. The FDA approval requires the company to run a pair of post-approval studies for Recover Right, 1 covering a 30-patient adult population and the 2nd a maximum of 15 pediatric patients.
"We are pleased to receive the HDE approval for the Impella RP. This is a milestone for the company as well as the interventional community in providing support for patients with right sided heart failure. Our Impella platform now has the ability to offer support for both sides of the heart, offering more treatment options for patients and hospitals," chairman, president & CEO Michael Minogue said in prepared remarks.
The Recover Right trial results showed an overall 73% 30-day survival rate in patients with right ventricular heart failure, according to data Abiomed released during the Transcatheter Cardiovascular Therapeutics conference in Washington last fall. The study enrolled patients into 2 cohorts: Those who developed right ventricular failure within 48 hours of receiving a left ventricular assist device (Cohort A) and those that developed RVF within 48 hours of post-cardiotomy shock or post-acute myocardial infarction shock (Cohort B). Cohort A showed a survival rate of 83.3% and Cohort B showed a 58.3% survival rate at 30 days.
The trial met the 30-patient enrollment goal in March 2014, later asking the FDA for permission to enroll more patients. In May Abiomed said the FDA approved a continuous access protocol for the trial allowing the enrollment of up to 22 more subjects over 6 months.