FDA Approves Instylla's Embrace® Hydrogel Embolic System 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 up to 6 mm. This approval follows its initial premarket approval for hypervascular tumor embolization and is supported by two prospective, multicenter pivotal clinical trials.