Abiomed 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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