Instylla水凝胶栓塞系统获FDA扩大批准：可用于直径6毫米以内外周动脉出血，130名患者试验临床成功率90%
总部位于 Massachusetts 州的医疗器械公司 Instylla 10月29日宣布，美国食品药品监督管理局（FDA）已批准其 Embrace 水凝胶栓塞系统（HES）扩大适应症，可用于直径6毫米及以下血管的外周动脉出血栓塞。
该系统2025年8月首次获得 FDA 上市前批准（PMA），当时适应症为直径5毫米及以下外周动脉的富血管肿瘤栓塞，目前已在美国上市销售。此次扩批后，它成为首款同时获批用于外周动脉出血与富血管肿瘤的液体栓塞产品。
此次批准依据 HALT 研究：一项前瞻性、多中心、单臂试验，在美国22家中心共入组130名外周动脉出血患者。Embrace HES 达到两项预设主要终点：重大不良事件发生率为零（100%无重大不良事件），临床成功率90.0%，即30天内目标病变无再出血。
该研究负责人、Boston Medical Center 介入放射科主任 Suvranu Ganguli 表示，治疗动脉出血需要能抵达出血源头、同时提供精准控制的栓塞方案；Embrace HES 可用单一栓塞剂按解剖结构实现远端或近端栓塞，且栓塞后仍可保留微导管通路，这与许多现有液体栓塞剂不同。
公司介绍，出血是创伤后可预防死亡的首要原因，动脉出血也可来自非创伤性来源，如非静脉曲张性上消化道出血、实质器官出血与肿瘤。Embrace HES 为水基聚乙二醇水凝胶，非黏附性设计消除了导管滞留的可能，不依赖患者自身凝血功能，约11个月内经水解液化。
Instylla 首席执行官 Sean Boyle 表示，复杂血管疾病患者需要更多选择，公司已在介入肿瘤与外周止血两个领域获得批准。
Instylla's Embrace Hydrogel Embolic System Wins Expanded FDA Approval for Peripheral Arterial Bleeds in Vessels Up to 6 mm, With 90% Clinical Success in a 130-Patient Trial
Instylla, Inc., a Massachusetts-based medical device company, announced on October 29 that the U.S. Food and Drug Administration (FDA) has approved an expanded indication for its Embrace Hydrogel Embolic System (HES) to include embolization of peripheral arterial bleeds in vessels up to 6 mm.
The system first received FDA premarket approval (PMA) in August 2025 for embolization of hypervascular tumors in peripheral arteries up to 5 mm, and is commercially available in the United States. With the expansion, it becomes the first and only liquid embolic approved for both peripheral arterial bleeds and hypervascular tumors.
The approval was based on the HALT study, a prospective, multicenter, single-arm trial that enrolled 130 patients with peripheral arterial bleeds at 22 U.S. sites. Embrace HES met both prespecified primary endpoints, with 100% freedom from major adverse events and 90.0% clinical success, defined as no rebleeding from the target lesion, through 30 days.
Suvranu Ganguli, MD, Chief of Interventional Radiology at Boston Medical Center and principal investigator of the HALT study, said treating an arterial bleed requires an embolic solution that can reach the source of bleeding while providing precise control, and that Embrace HES allows either distal or proximal embolization with a single agent while maintaining microcatheter access after embolization, unlike many currently available liquid embolics.
Hemorrhage is the leading cause of potentially preventable death after trauma, the company noted, and arterial bleeding also arises from non-traumatic sources such as non-variceal upper gastrointestinal bleeding, solid-organ bleeds and tumors. Embrace HES is a water-based polyethylene glycol hydrogel whose non-adhesive design eliminates the possibility of catheter entrapment, is coagulation independent, and liquifies via hydrolysis over approximately 11 months.
Sean Boyle, CEO of Instylla, said patients facing complex vascular conditions need more options, and that with approvals now in both interventional oncology and peripheral hemostasis the company is building a platform for further vascular conditions.
来源：GSM·美国（原文链接）
图片来源：图：心导管实验室内的导管操作实景（资料图，与介入栓塞治疗题材相关）。Navy Medicine 图，公共领域，经 Wikimedia Commons。Photo: A catheterization procedure in a hospital cath lab (file photo). Navy Medicine, public domain, via Wikimedia Commons.
