Regulatory Focus™ > News Articles > 2019 > 5 > FDA Updates Mortality Rate Linked to Heart Pump in Post-Approval Study

FDA Updates Mortality Rate Linked to Heart Pump in Post-Approval Study

Posted 21 May 2019 | By Ana Mulero 

FDA Updates Mortality Rate Linked to Heart Pump in Post-Approval Study

Patients in a post-approval study (PAS) for Abiomed’s heart pump Impella RP reported lower survival rates when compared to premarket studies, the US Food and Drug Administration (FDA) reported Tuesday.

The update from the latest PAS report indicates 28.6% (12 out of 42 patients) met the primary survival endpoint, which compares with 17.4% (4 out of 23 patients) reported in February.

Despite the higher rate of mortality, FDA said that when the device is used “for the currently approved indication in appropriately selected patients the benefits of the Impella RP system continue to outweigh the risks.”

In a statement Abiomed told Focus: “FDA has no safety concerns about the Impella RP itself and noted the ongoing collaboration between the agency and Abiomed during this process, including interactive labeling updates around patient selection guidelines and best practices.” The agency approved revised labeling to include additional information about patient selection last month.

“The 18-month PAS report has been accepted by the FDA and is successfully closed,” the company added.

FDA noted that the primary reason for the difference in survival outcome between the premarket and postmarket studies “appears to be patient selection. For the subgroup of PAS patients who would have met the enrollment criteria for the premarket clinical studies, the survival rate was 64.3 percent (9 out of 14 patients) which is similar to the premarket clinical study survival rate.”

FDA also clarified that “the PAS survival rate should be interpreted in the context of the patients’ conditions and limited treatment options.” 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, experience a cardiac arrest or suffered a pre-implant hypoxic or ischemic neurologic event.”

FDA

Categories: Regulatory News

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