Devices

Abiomed Small Heart Pump Study Approved

FDA has approved an Abiomed IDE to start an early feasibility study with a first-in-human trial of the 9 French Impella Expandable Cardiac Power (ECP) heart pump. The device will be studied in high-risk percutaneous coronary intervention (PCI) patients, the company says.

Impella ECP is the world’s smallest heart pump, according to the company, providing peak flows greater than 3.5 L/min and is delivered through a slender-profile sheath. “It is un-sheathed in the descending aorta and expands to approximately 18 Fr,” it says. “Using a specially designed pigtail, it crosses the aortic valve without a wire, and pumps from inside the ventricle. When the procedure is complete, the pump is re-sheathed back down to 9 Fr and removed with that same profile.”

Abiomed says the pump is intended to sit across the valve with a soft atraumatic polyurethane cannula that opens only when the pump is flowing. If the pump stops for any reason, this cannula relaxes allowing the valve leaflets to close around it, which maintaine valve competency. The pump is intended for short-term mechanical support in patients undergoing a high-risk PCI, to provide both circulatory support and left ventricular unloading, it 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