Abiomed has received US Food and Drug Administration's (FDA) investigational device exemption (IDE) to begin a pivotal clinical study of its Impella Right-side Percutaneous (RP ) pump.
The percutaneous heart pump is implanted through a single access site in the patient’s leg and is deployed across the right side of the heart without requiring a surgical procedure.
The RECOVER RIGHT study, which will enroll 30 patients who have signs of right side heart failure and require hemodynamic support, is designed to assess the safety and efficacy of the device.
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 chief executive officer 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.
The company said 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.