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The Food and Drug Administration issued a letter on Feb. 4, 2019, to health care providers regarding interim results from a postapproval study for Abiomed’s Impella RP System because these results appear to have a higher mortality rate than was seen in premarket clinical studies.
As a condition of its approval, the FDA mandated Abiomed to perform a postapproval study (PAS); this study reflects use in a broader population than the premarket studies, which adhered to stricter inclusion and exclusion criteria.
Earlier in January, Abiomed submitted data to the FDA suggesting that differences in preimplant characteristics between patients in the PAS and those in the premarket clinical studies may explain the difference in mortality. Specifically, 16 of the 23 patients enrolled in the PAS would not have met the enrollment criteria for the premarket clinical studies because they were in cardiogenic shock for longer than 48 hours, experienced an in-hospital cardiac arrest, were treated with an intra-aortic balloon pump, or suffered a preimplant hypoxic or ischemic neurologic event.
“Although the FDA is concerned about the high mortality rate from the interim PAS results,” they wrote in the letter, which is available on the FDA website, “we believe 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 Food and Drug Administration issued a letter on Feb. 4, 2019, to health care providers regarding interim results from a postapproval study for Abiomed’s Impella RP System because these results appear to have a higher mortality rate than was seen in premarket clinical studies.
As a condition of its approval, the FDA mandated Abiomed to perform a postapproval study (PAS); this study reflects use in a broader population than the premarket studies, which adhered to stricter inclusion and exclusion criteria.
Earlier in January, Abiomed submitted data to the FDA suggesting that differences in preimplant characteristics between patients in the PAS and those in the premarket clinical studies may explain the difference in mortality. Specifically, 16 of the 23 patients enrolled in the PAS would not have met the enrollment criteria for the premarket clinical studies because they were in cardiogenic shock for longer than 48 hours, experienced an in-hospital cardiac arrest, were treated with an intra-aortic balloon pump, or suffered a preimplant hypoxic or ischemic neurologic event.
“Although the FDA is concerned about the high mortality rate from the interim PAS results,” they wrote in the letter, which is available on the FDA website, “we believe 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 Food and Drug Administration issued a letter on Feb. 4, 2019, to health care providers regarding interim results from a postapproval study for Abiomed’s Impella RP System because these results appear to have a higher mortality rate than was seen in premarket clinical studies.
As a condition of its approval, the FDA mandated Abiomed to perform a postapproval study (PAS); this study reflects use in a broader population than the premarket studies, which adhered to stricter inclusion and exclusion criteria.
Earlier in January, Abiomed submitted data to the FDA suggesting that differences in preimplant characteristics between patients in the PAS and those in the premarket clinical studies may explain the difference in mortality. Specifically, 16 of the 23 patients enrolled in the PAS would not have met the enrollment criteria for the premarket clinical studies because they were in cardiogenic shock for longer than 48 hours, experienced an in-hospital cardiac arrest, were treated with an intra-aortic balloon pump, or suffered a preimplant hypoxic or ischemic neurologic event.
“Although the FDA is concerned about the high mortality rate from the interim PAS results,” they wrote in the letter, which is available on the FDA website, “we believe 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.”