Devices

Instylla PMA Approved for Hypervascular Tumors

FDA has approved an Instylla PMA for its Embrace Hydrogel Embolic System (HES), a liquid embolic device for treating hypervascular tumors in peripheral arteries measuring 5 millimeters or less. Hypervascular tumors, which are commonly found in the liver, kidneys, bones, and other organs, are typically difficult to treat due to their rich blood supply, which increases the risk of bleeding during surgery and limits treatment options, according to the company. For many patients, transcatheter arterial embolization and transarterial chemoembolization are standard therapies used to cut off blood flow to tumors, helping to control disease progression, it says.

Embrace HES uses two low-viscosity liquid precursors that, when injected together into the blood vessels, react to form a polyethylene glycol hydrogel, Instylla says. This in situ polymerization creates a soft embolic that deeply penetrates tumor vasculature, effectively cutting off blood supply to the tumor while minimizing damage to surrounding tissue, it adds.

FDA approval was based on a prospective, randomized, multicenter pivotal trial comparing Embrace HES to standard embolization therapies in 150 patients with hypervascular tumors. The study showed that Embrace HES achieved 88.6% technical success and 99% freedom from major adverse events, according to the company, adding that no adverse events were related solely to the device.

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