Instylla Receives the US FDA’s Approval for Expanded Indication of Embrace Hydrogel Embolic System to Treat Peripheral Arterial Bleeds

Shots: The US FDA has approved the expanded indication of Instylla’s Embrace Hydrogel Embolic System (HES) to include embolization of peripheral arterial bleeds in vessels ≤6mm, following its initial PMA in Aug 2025 for hypervascular tumor embolization Approval was based on the HALT study in 130 patients with peripheral arterial bleeds across 22 US sites, where Embrace HES met both 1EPs with 100% freedom from major adverse events & 90.0% clinical success (no rebleeding from the target lesion) through 30 days Embrace HES is a water-based polyethylene glycol hydrogel that forms in the vessel, is coagulation independent & liquifies over ~11 mos.; it is commercially available in the US Ref: PR Newswire  |   Image: Instylla  |  Press Release PharmaShots, your go-to media platform for customized news ranging across multiple indications. For more information, connect with us at connect@pharmashots.com The post Instylla Receives the US FDA’s Approval for Expanded Indication of Embrace Hydrogel Embolic System to Treat Peripheral Arterial Bleeds appeared first on PharmaShots.