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Parker Waichman LLP

05/28/2019 | News release | Distributed by Public on 05/28/2019 13:11

FDA Abiomed Impella RP Heart Pump System Warning

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Abiomed Impella RP Heart Pump System

WASHINGTON, D.C. - The U.S. Food and Drug Administration issued an alert regarding unindicated use of Abiomed Impella RP Heart Pump System. The FDA announced in a letter to healthcare providers dated May 21, 2019 that post-approval studies show that off-indication use of the heart pump system correlates to premature death. However, the FDA reasserted its position that patients selected to use the system in a pre-market analysis show great promise and the benefits of implanting the system in these patients significantly outweighs the risk associated with the pump according to Medscape. The letter sent by the FDA to cardiologists, transplant surgeons, and cardiothoracic surgeons updated a letter sent by the FDA to the same group of treatment providers in February of 2019. The results are interim results and are not the final analysis of the efficacy of Abiomed's Impella RP Heart Pump System.

The FDA approved the Abiomed Impella RP Heart Pump System in 2017. The FDA approved the medical device to help support the heart's right ventricle for up to two weeks in certain patients who suffer from right ventricular decompensation or failure after a medical device implant or adverse health event in the left side of the heart. In pre-market studies, the survival rate for a patient was over 73%. However, post-approval studies revealed that approximately 29% of patients survived for 30 days after the device was removed, the patients were discharged from the hospital, or the patient received a long-term therapy option.

The FDA and Abiomed worked closely to come to an understanding about the disparity of survival rates. The parties determined that the patients had a higher survival rate in the pre-market study because of a more stringent selection process for patients to participate in the pre-market study. The FDA stated that it would continue to work closely with Abiomed to complete the necessary investigations. Additionally, the FDA warned healthcare providers to select patients who satisfy the pre-market data as appropriate candidates for the therapy at this time.