Impella® heart assist device maker Abiomed, Inc. has received Investigational Device Exemption (IDE) approval from the FDA for the use of its new Impella RP (Right-side Percutaneous) in a pivotal clinical study in the United States.
Abiomed has good reason to describe its Impella RP as a breakthrough percutaneous heart pump, given that there really is nothing else like it. The device 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.
This 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 ten 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 catheterisation 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).
“This FDA IDE approval for our Impella RP is a major milestone for the Company and we look forward to collecting data on this unique patient population with an unmet medical need,” said Michael R. Minogue, President, Chairman and Chief Executive Officer, Abiomed.
Prior to submitting an HDE, a HUD (Humanitarian Use Device) approval is necessary from the FDA, which Abiomed received on 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.”
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.
Source: Abiomed Inc., Globe Newswire