Instylla's Embrace® Hydrogel Embolic System Receives FDA Approval for Peripheral Arterial Bleeds

The U.S. Food and Drug Administration (FDA) has approved an expanded indication for Instylla's Embrace® Hydrogel Embolic System (HES) to include the embolization of peripheral arterial bleeds in vessels ≤ 6 mm. This approval follows its initial premarket approval in August 2025 for hypervascular tumor embolization, making it the first liquid embolic approved for both indications. The approval was based on the HALT study, which demonstrated 100% freedom from major adverse events and 90.0% clinical success through 30 days in patients with peripheral arterial bleeds.