Abiomed Receives FDA IDE Approval for Use of New Impella RP in Pivotal Clinical Study
Abiomed (NASDAQ: ABMD), a leading provider of breakthrough heart support technologies, announced today that it 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.
The Impella RP is a breakthrough 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.
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 catheterization lab or cardiac surgery suite.
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