FDA Approves New Hydrogel System for Treating Peripheral Arterial Bleeds

The U.S. Food and Drug Administration (FDA) has granted approval for the Embrace Hydrogel Embolic System, a medical device designed to treat peripheral arterial bleeds in vessels 6 mm or less. This system uses a water-based polyethylene glycol hydrogel to create a sustained vessel occlusion, offering a non-surgical option for managing arterial bleeding. The approval follows evidence from the HALT clinical trial, which evaluated the device in 130 patients across 22 U.S. sites.