The US Food and Drug Administration (FDA) has granted investigational device exemption (IDE) to Abiomed to initiate a pivotal clinical study of its percutaneous heart pump.
The Impella Right-side Percutaneous (RP) pump, which is implanted through a single access site in the patient’s leg, is deployed across the right side of the heart without requiring a surgical procedure.
The study, named RECOVER RIGHT, will enrol 30 patients who have signs of right side heart failure, require hemodynamic support and are being treated in the catheterisation lab or cardiac surgery suite.
The trial, which is designed to assess the safety and efficacy of Impella RP, will be led by Mark Anderson, cardiothoracic surgery chair of Einstein Healthcare Network, and William O’Neill, Centre for Structural Heart Disease medical director at Henry Ford Hospital.
The company will use the safety and effectiveness data to submit a humanitarian device exemption (HDE) application, which is similar to a premarket approval application but is intended for patient populations of 4,000 or less per year in the US.
Abiomed president, chairman and CEO Michael Minogue said; "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."
The study, which is expected to begin in early 2013, will take up to 24 months to complete.
Abiomed is also planning a pivotal biventricular study of Impella RP, in combination with the Impella left-side devices, according to the company.