FDA approved an expanded indication for Instylla's Embrace Hydrogel Embolic System, covering embolization of peripheral arterial bleeds in vessels 6 mm or smaller. Instylla announced the decision on October 29. Embrace won its original premarket approval in August 2025, for hypervascular tumors in peripheral arteries 5 mm or smaller.
The expansion rests on HALT, a prospective single-arm study of 130 patients with peripheral arterial bleeds at 22 US sites. Instylla reported 100 percent freedom from major adverse events through 30 days. Clinical success, defined as no rebleeding from the target lesion, was 90.0 percent.
Embrace is delivered as a liquid that gels inside the vessel. Suvranu Ganguli of Boston Medical Center, the HALT principal investigator, said the design lets an operator keep microcatheter access after embolization. That is the practical argument against coils and glue, which interventional radiologists already know well, and it is the kind of workflow claim that sells a second indication faster than the outcome data does.
Instylla is based in Burlington, Massachusetts, and was founded in 2017 by Incept LLC.