Abiomed, a medical device manufacturer based in Danvers, Massachusetts, recently received approval from the United States Food and Drug Administration for a clinical trial of its Impella RP heart pump. The Impella RP heart pump is designed to provide cardiac assistance for the right side of the heart.
The Impella RP is similar to the company’s flagship product, the Impella. Both devices are inserted into the heart through the femoral artery in a patient’s thigh. However, all previous Impella models were designed to operate in the left ventricle of the heart. The new Impella RP crosses the heart’s septum to work in the right ventricle.
According to a press release from Abiomed, the two year clinical trial will use 30 patients and will start in the early part of next year. To qualify, patients must have failure of the right side of the heart. In addition, patients must require hemodynamic support, cardiac surgery treatment or catheterization to enter the trial. The trial was approved by the FDA under its Humanitarian Device Exemption.
In prepared remarks, 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.”
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