May 28, 2019
FDA Confirms Safety and Efficacy of Abiomed's Impella RP for Right Heart Failure
May 28, 2019—Abiomed announced that the FDA has sent a letter to health care providers that validates the safety and efficacy of the company's Impella RP heart pump for treatment of right heart failure.
The letter comes after the FDA examined the results from Abiomed’s 18-month postapproval study (PAS) of 42 patients treated with the Impella RP device. The data show a 64% survival rate and 90% heart recovery for the subgroup of PAS patients (n =14) who met the enrollment criteria of Impella RP’s premarket clinical studies.
In the letter, the FDA advised that the survival rate is “similar to the premarket clinical study survival rate,” which was 73%. In a control-group humanitarian device exemption study, a non-Impella surgical device used with the same protocol showed a survival rate of 43%.
According to Abiomed, the FDA letter emphasizes the need for early patient selection and determines late identification and treatment of cardiogenic shock as the root cause of differences between the survival rate in the premarket study and the PAS.
The FDA stated, “PAS patients who would not have qualified for the premarket clinical studies were more likely to have been in cardiogenic shock for longer than 48 hours, experienced a cardiac arrest, or suffered a preimplant hypoxic or ischemic neurologic event before getting the Impella RP system implanted.”
The company advised that health care providers are encouraged to use the Impella RP checklist, which the FDA and Abiomed collaborated to develop, to assist with proper patient selection to optimize outcomes.
Abiomed further stated that the FDA has no safety concerns about the Impella RP itself and noted the ongoing collaboration between the agency and the company during this process, including interactive labeling updates around patient selection guidelines and best practices. The 18-month PAS report has been accepted by the FDA and is successfully closed.
In the United States, the Impella RP device is FDA approved to treat right heart failure or decompensation after left ventricular assist device implantation, myocardial infarction, heart transplant, or open heart surgery.
The device has received European CE Mark approval to treat right heart failure or decompensation following left ventricular assist device implantation, myocardial infarction, heart transplant, open heart surgery, or refractory ventricular arrhythmia, stated Abiomed.