The US Food and Drug Administration (FDA) has cleared an expanded indication for Instylla’s Embrace hydrogel embolic system (HES) to treat peripheral arterial bleeds in vessels measuring up to 6mm.
The product is a water-based polyethene glycol hydrogel that is commercially available in the country.
The regulatory decision follows the device’s original premarket approval (PMA) granted in August 2025 for embolising hypervascular tumours in peripheral arteries measuring up to 5mm.