Instylla’s Embrace HES Approved for Peripheral Arterial Bleeds

October 29, 2026—Instylla, Inc., a developer of resorbable embolics for peripheral vascular embolization, announced that the FDA has approved an expanded indication for the company’s Embrace hydrogel embolic system (HES) to include embolization of peripheral arterial bleeds in vessels ≤ 6 mm. Embrace HES was launched commercially in the United States in January 2026.

According to Instylla, the initial premarket approval for the Embrace HES was for hypervascular tumor embolization in peripheral arteries ≤ 5 mm, which was granted in August 2025. The initial approval was based on findings from the pivotal HALT trial. The prospective, multicenter, single-arm trial, which commenced in January 2023, enrolled 130 patients with peripheral arterial bleeds at 22 sites in the United States.

The company reported that the Embrace HES met the study’s prespecified primary endpoints with 100% freedom from major adverse events and 90.0% clinical success (no rebleeding from the target lesion) through 30 days. Suvranu Ganguli, MD, served as Principal Investigator of the HALT study.

Dr. Ganguli and Susie Park, MD, commented on the Embrace HES and its newly approved indication in the Instylla press release.

“When treating an arterial bleed, you need an embolic solution that can reach the source of bleeding while providing precise control,” stated Dr. Ganguli. “Embrace HES allows you to tailor your approach to the anatomy, achieving either distal or proximal embolization with a single embolic agent. Its novel design also allows you to maintain microcatheter access after embolization, unlike many currently available liquid embolics. This combination of control, versatility, and preserved access makes it a valuable new option for interventional radiologists.”

Dr. Park added, “What sets Embrace HES apart is its safety profile and controlled deliver. In the HALT study, I saw firsthand how its design features help minimize nontarget embolization and allow you to adjust the embolic placement. I’m looking forward to what this expanded indication could mean for patients.”