Devices

LimFlow Gains Approval for Leg Ischemia

FDA has approved a LimFlow PMA for its LimFlow System for treating patients with chronic limb-threatening ischemia (CLTI) who have no other suitable endovascular or surgical treatment options and are facing major amputation. The device allows transcatheter arterialization of deep veins (TADV) and it is designed to reestablish blood flow in deep veins for “no-option” CLTI patients. It “bypasses permanently blocked arteries in the leg and foot and delivers oxygenated blood back into the foot via the veins,” according to the company. “Restoring perfusion in the lower limbs may help resolve chronic pain, improve quality of life, enable wound healing, and prevent major amputation,” it says.

Approval was based on data from the PROMISE II pivotal trial, according to the company, and from positive clinical results seen in earlier studies. “In the PROMISE II study, 76% of no-option CLTI patients were able to keep their leg and experienced progressive wound healing, with many having significant pain relief during the time following LimFlow treatment,” LimFlow says. Click her e to view a video of how the LimFlow System for TADV works.

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