FDA Tweaks Impella Indications on Basis of Post-Approval Study
The US Food and Drug Administration (FDA) has updated the Abiomed Impella RP System’s approved indications in a way that “better reflects the characteristics of the patients who may benefit the most from treatment with the device,” the agency has announced.
The revised language reflects the final results of a post-approval study in which survival rates for patients who met the premarket-study entry criteria were comparable to rates seen in the premarket studies, the FDA observed.
The post-approval study “further confirms that the device is safe and effective when used for the currently approved indication.” The indication’s added words, however, tighten the description of eligible patients in a way that more precisely reflects the premarket study population.
The update states that the Impella RP System is “indicated for providing temporary right ventricular support for up to 14 days in patients with a body surface area ≥ 1.5 m2, who develop acute right heart failure or decompensation for less than 48 hours following left ventricular assist device implantation, myocardial infarction, heart transplant, or open‐heart surgery, without the presence of profound shock, end organ failure, or acute neurologic injury.”
The FDA “believes 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.”
The reworded indication is the latest among several updates to the agency’s February 2019, letter to clinicians noting a signal of increased mortality associated with the Impella RP device in an interim analysis of the same post-approval study. Ultimately, no such signal has emerged among the subset of post-approval patients who would have been eligible for the premarket study.
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