November 12, 2012 — Abiomed Inc. said it received an investigational device exemption (IDE) approval from the U.S. Food and Drug Administration (FDA) for the use of the new Impella RP (right-side percutaneous) in a pivotal clinical study in the United States.
The Impella RP is a percutaneous heart pump that is implanted through a single access site in the patient's leg and deployed across the right side of the heart without requiring a surgical procedure.
The IDE approval enables the use of the Impella RP in a clinical study called RECOVER RIGHT, led by principal investigators Mark Anderson, M.D., chair of the division of cardiothoracic surgery at Einstein Healthcare Network, and William O'Neill, M.D., medical director of the Center for Structural Heart Disease at Henry Ford Hospital. The study, which is expected to begin in early 2013, will enroll 30 patients from 10 different hospital sites and is estimated to take up to 24 months to complete. The study will enroll patients that present with signs of right-side heart failure, require hemodynamic support and are being treated in the catheterization lab or cardiac surgery suite.
The RECOVER RIGHT study will collect safety and effectiveness data on the percutaneous use of the Impella RP and will be applied towards the submission of a humanitarian device exemption (HDE). An HDE is similar to a premarket approval (PMA) application but is intended for patient populations of 4,000 or less per year in the United States. In order to receive an HDE, there must be no comparable devices approved under PMA that are available to treat the targeted population. An approved HDE authorizes sales of the device to any hospital after Institutional Review Board review.
Prior to submitting an HDE, a humanitarian use device (HUD) approval is necessary from the FDA, which Abiomed received July 13, 2012. The HUD-approved indication for the Impella RP device in this study is "to provide temporary circulatory support for patients in cardiogenic shock, which is due to acute right ventricular failure," said Michael R. Minogue, president, chairman and CEO of Abiomed.
In the future, Abiomed plans to expand its clinical experience with the Impella RP through a pivotal biventricular "Bridge to Recovery" study, in combination with the Impella left-side devices.
For more information: www.abiomed.com