Drugs

High Mortality Rate with Abiomed’s Impella RP System: FDA

FDA says it is evaluating recent interim post-approval study (PAS) results which suggest a higher mortality rate for patients treated with Abiomed’s Impella RP System than the rate previously observed in premarket clinical studies. The Impella RP System is a temporary right heart pump system intended to help patients maintain stable heart function without open chest surgery. “Although the FDA is concerned about the high mortality rate from the interim PAS results, 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,” a device safety alert says.

In premarket clinical studies, where strict inclusion and exclusion criteria were followed, a total of 44 out of 60 patients (73.3%) survived to 30 days post device explant or hospital discharge (whichever was longer), or to the start of next longer term therapy, FDA says. “Interim results from the most recent PAS report, which reflect device use in a broader patient population, indicate that only 4 out of the 23 enrolled PAS patients (17.4%) met the primary survival endpoint,” it says.

FDA required additional analyses from Abiomed, and data submitted last month “suggest that the high mortality rate observed in the PAS may be primarily related to differences in pre-implant characteristics of the PAS patients compared to the patients in the premarket clinical studies,” the agency says. “Sixteen (16) of the 23 patients enrolled in the PAS would not have met the enrollment criteria for the premarket clinical studies.”

Gupta Raises Concerns About Overton’s Independence, Ideology

FDA commissioner nominee Heidi Overton’s responses on vaccines, contraception and abortion medication during her 9/24 Senate confirmation hearing raise concerns that ideology could influence her decision-making if she takes over the agency, MSNBC senior medical analyst Dr. Vin Gupta said Friday. Gupta was particularly critical of Overton’

Overton Confirmation Remains Uncertain After Senate Hearing

FDA commissioner nominee Heidi Overton emerged from her Senate confirmation hearing Thursday (see earlier story) without resolving questions about whether she has enough Republican support to advance — and with a rapidly narrowing window for confirmation before the midterm elections. The Senate Health, Education, Labor and Pensions Committee hearing provided few

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA has classified Boston Scientific's recall of its Imager II Angiographic Catheters as Class I because a manufacturing problem could cause catheter tips to degrade and detach, potentially resulting in life-threatening complications. The agency announced the Class I classification 9/25, updating an Early Alert it issued

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome

FDA has approved Roche’s Gazyva (obinutuzumab) for reducing the risk of relapse in adults and children aged 2 and older with frequently relapsing or steroid-dependent, childhood-onset idiopathic nephrotic syndrome who are in remission. The expanded approval covers the use of the CD20-directed antibody beyond its existing

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Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome