Drugs

Impella Heart Pump Survival Data ‘Favorable:’ FDA

FDA says that most recent, interim post-approval study (PAS) results for the Impella RP System continue to show the survival rate for the subgroup of PAS patients who would have met the enrollment criteria for the premarket clinical studies (72.7%, 16 out of 22 patients) is similar to the premarket clinical study survival rate (73.3%) while the survival rate for the subgroup of PAS patients who would not have qualified for the premarket clinical studies is lower (13.6%, six out of 44 patients).

In May, FDA issued a revised safety update on the device that emphasized proper patient selection after interim post-approval study results then indicated a lower survival rate for the subgroup of PAS patients who would not have qualified for inclusion in clinical studies performed before the device was approved. The Impella RP System is a temporary right heart pump system intended to help patients maintain stable heart function without open chest surgery.

“Based on our current analysis, 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 agency’s update says.

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