Shares of Abiomed Inc. (Nasdaq:ABMD) are up more than 14% to $46 in after hours trading, as traders react to the company’s announcement that the Impella RP® (Right Percutaneous) System has received FDA approval under a Humanitarian Device Exemption (HDE). Abiomed said this innovative medical device is the first percutaneous single access heart pump designed for right heart support to receive FDA approval. Abiomed completed the HDE submission for the Impella RP in September 2014 following the completion of the RECOVER RIGHT study.
Delivered through a catheter requiring only a small hole in the leg, the Impella RP is FDA indicated for providing circulatory assistance for up to 14 days 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. These patients lack blood flow from the right side of their hearts. The Impella RP is designed to provide the flow and pressure needed to compensate for right heart failure. The device does not require a surgical procedure for insertion, and it provides up to four liters per minute of hemodynamic support.
“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,” said Mark Anderson, M.D., co-principal investigator for the RECOVER RIGHT trial and chair of the division of cardiothoracic surgery at Einstein Medical Center.
“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,” said Michael R. Minogue, Chairman, President and Chief Executive Officer, Abiomed.
There will be a controlled launch of the Impella RP in the U.S. after each site completes in-house training at Abiomed. This rigorous training will incorporate members of the heart team, including the interventional cardiologist, cardiac surgeon, heart failure cardiologist and lead nurse.
As part of the HDE approval, Abiomed is required to conduct two post approval studies (PAS) for the RECOVER RIGHT. One includes an adult patient population of 30 patients and the other, a pediatric patient population for a maximum of 15 patients (larger patients < 18 years of age with RVF.) These studies will be conducted to monitor the post-market safety and probable benefit of the Impella RP device. Both studies will be a single-arm multicenter studies that will follow the respective patients at 30 and 180 days post device explant.