FDA Expands Instylla Embrace HES Approval to Arterial Bleeds
Burlington – October 29, 2026 -- The U.S. Food and Drug Administration has approved an expanded indication for Instylla's Embrace Hydrogel Embolic System (HES), covering embolization of peripheral arterial bleeds in vessels of 6 mm or less. Embrace HES is now the first and only liquid embolic approved for both peripheral arterial bleeds and hypervascular tumors, according to the privately held company. The product is commercially available in the U.S.
HALT trial met both primary endpoints in 130 patients
The approval rests on the HALT study, a prospective, multicenter, single-arm trial that enrolled 130 patients with peripheral arterial bleeds at 22 U.S. sites. Embrace HES delivered 100% freedom from major adverse events and 90.0% clinical success, defined as no rebleeding from the target lesion, through 30 days. Both were prespecified primary endpoints.