FDA expands Instylla Embrace Hydrogel Embolic System approval to peripheral arterial bleeding
The FDA has expanded approval of Instylla's Embrace Hydrogel Embolic System to peripheral arterial bleeding, supported by clinical evidence from the multicentre HALT study.
The expanded premarket approval authorises the Embrace Hydrogel Embolic System for embolisation of peripheral arterial bleeding in vessels measuring 6 mm or less, extending its previously approved use in hypervascular tumour embolisation.
In the prospective HALT study involving 130 patients across 22 US sites, the company reported 90% clinical success and 100% freedom from major adverse events through 30 days, supporting the device's additional indication.
Field | Content |
Article Type | Approvals |
Regulatory Authority | U.S. Food and Drug Administration |
Regulatory Decision | Expanded premarket approval indication |
Approval Announcement Date | 29 October 2026 |
Company | Instylla |
Device Name | Embrace Hydrogel Embolic System |
Device Type | Hydrogel embolisation system |
Therapeutic Area | Interventional radiology; vascular intervention |
New Approved Indication | Embolisation of peripheral arterial bleeding |
Eligible Vessel Size | 6 mm or less |
Previous Approved Indication | Hypervascular tumour embolisation |
Previous Approval Date | August 2025 |
Supporting Clinical Study | HALT |
Study Design | Prospective multicentre clinical study |
Study Population | 130 patients |
Study Sites | 22 US sites |
Reported Clinical Success | 90% |
Reported Major Adverse Event Outcome | 100% freedom from major adverse events through 30 days |
Follow-up Period | 30 days for reported major adverse event outcome |
Geography | United States |
What Happened | The FDA expanded the Embrace Hydrogel Embolic System's premarket approval to include peripheral arterial bleeding in vessels measuring 6 mm or less. |
Why It Matters | The new indication broadens embolisation options for interventional specialists managing peripheral arterial bleeding. |
Clinical Evidence | HALT enrolled 130 patients at 22 US centres and reported 90% clinical success and 100% freedom from major adverse events through 30 days. |
Regulatory Distinction | This is an additional approved indication for an existing device, not its initial FDA approval. |
Key Takeaway | Instylla's Embrace system can now be used for approved peripheral arterial bleeding procedures in eligible vessels. |
What to Watch | Hospital adoption, physician training, reimbursement, real-world safety, procedural outcomes and further clinical evidence. |
Primary Source | Instylla via PR Newswire |
Primary Source URL | https://www.prnewswire.com/news-releases/instyllas-embrace-hydrogel-embolic-system-receives-fda-approval-for-peripheral-arterial-bleeds-302922926.html |
Relevant Date | 29 October 2026 |
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