Devices

Boston Scientific Recalls Obsidio Embolic

Boston Scientific is recalling (Class 1) its embolic agent Obsidio Embolic by issuing a correction after an investigation determined that delivery of the device using the aliquot technique, a commonly used delivery method in embolization procedures, for lower gastrointestinal bleeding embolization poses a high risk of bowel ischemia. To date, there have been 11 incidents reported, seven injuries, and two deaths related to the issue.

The device is a premixed embolic agent that is delivered to occlude blood flow to specific blood vessels. After injection, it creates a “solid cast” in the vessel and halts blood flow, FDA says.

“The most serious and the most common adverse health consequence is the need to perform major surgery such as bowel resection and/or diverting colostomy,” a recall notice says. Using the product with the aliquot technique may prevent blood and oxygen flow to organs including the small bowel (ischemia) or non-target embolization, which could lead to prolonged hospitalization, the need for additional surgery or death, it says.

The notice indicates that Boston Scientific does not recommend that the aliquot technique be used to deliver Obsidio Embolic for lower GI bleed embolization procedures.

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