Devices

FDA Nixes Post-marketing Requirements on Impella Pumps

FDA has closed its post-approval study requirements for Abiomed PMA for its Impella heart pumps. As a result, the company says the agency has affirmed that the pumps are safe and effective for cardiogenic shock, high-risk percutaneous coronary intervention (PCI), post-cardiotomy cardiogenic shock, cardiogenic shock in the setting of myocarditis or cardiomyopathy, and right heart failure.

Overall, Abiomed says it completed five post-approval studies for Impella over the seven years since its initial PMA was received, which included 46 sites and 1,833 patients. Data show that Impella-supported PCI improves quality of life with a 22% to 45% improvement in left ventricular ejection fraction at a 90-day follow up, a 58% to 80% reduction in New York Heart Association Class III and IV symptoms, and 29% to 47% fewer adverse events at 90 days, it says. And data also showed that Impella’s use in cardiogenic shock resulted in 71% to 82% survival, and 90% to 99% native heart recovery.

“Impella is the most studied heart pump in the history of the FDA, with studies being conducted from 2006 to the present,” Abiomed says. “Real-world data exists on nearly 200,000 Impella patients … and Impella is the subject of more than 1,200 peer-reviewed publications,” it says, adding that the pumps are included in 13 clinical society guidelines.

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