Abiomed Inc Receives FDA IDE Approval For Use Of New Impella RP In Pivotal Clinical Study

Abiomed Inc announced that it has received Investigational Device Exemption (IDE) approval from the Food & Drug Administration (FDA) for the use of the new Impella RP (Right-side Percutaneous) in a pivotal clinical study in the United States. This IDE approval enables the use of the Impella RP in a clinical study called RECOVER RIGHT, led by principal investigators Mark Anderson, chair of the Division of Cardiothoracic Surgery at Einstein Healthcare Network and William O'Neill, 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 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).