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.
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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.
Data supporting the expanded clearance were obtained from the prospective, single-arm HALT clinical trial across 22 US centres involving 130 patients presenting with peripheral arterial haemorrhage.
The study achieved both designated primary endpoints.
Evaluated over 30 days, the device demonstrated 100% freedom from major adverse events and achieved clinical success of 90%, defined as the absence of further bleeding from targeted lesions.
Instylla CEO Sean Boyle said: “Patients facing complex vascular conditions need more options. Embrace HES was built to deliver that versatility.
“With approvals now in both interventional oncology and peripheral haemostasis, we’re redefining what’s possible in interventional care and building a transformative platform for the many vascular conditions still ahead.”
Embrace HES solidifies inside blood vessels to establish rapid, lasting occlusions before breaking down through hydrolysis over nearly 11 months.
The non-adhesive formulation prevents catheter entrapment and works independently of coagulation pathways. It also contains no dimethyl sulfoxide (DMSO) and incorporates no elements that distort CT or MRI imaging.
It targets acute vascular trauma, as well as non-traumatic sources, including solid-organ bleeds, tumours, and non-variceal upper gastrointestinal bleeding where conventional endoscopy fails.
While transcatheter arterial embolisation records success rates between 81% and 100% in unstable pelvic fractures, traditional mechanical solutions such as coils remain reliant on native clotting mechanisms and lose effectiveness in patients with coagulopathy.
Instylla is a privately held enterprise situated in Burlington, Massachusetts, US, focused on developing resorbable vascular occlusion therapies.
