InspireMD颈动脉支架获美国食品药品监管局批准用于经颈动脉手术，美国市场空间翻倍
颈动脉支架开发商 InspireMD 公司（纳斯达克代码：NSPR）2026年11月12日在佛罗里达州 Miami 宣布，美国食品药品监管局（FDA）已批准其 CGuard Prime 经颈动脉支架系统的上市前批准（PMA）补充申请，该系统可用于经颈动脉血运重建（TCAR）手术。
获批系统配有80厘米输送系统，须与标签指定的栓塞保护系统配合使用。其自膨式镍钛合金支架外覆有 MicroNet 永久性微网保护层。公司称，有了这一批准，医生在 TCAR 手术中也能使用 CGuard Prime 支架，公司由此成为同时提供颈动脉支架置入（CAS）与 TCAR 两种入路的企业。
批准依据是 CGUARDIANS II 关键试验数据：这项前瞻性、多中心、单臂美国研究在11个研究中心纳入50名关键试验患者，受试者为手术高风险人群，使用已获 FDA 许可的 ENROUTE 经颈动脉神经保护系统。术后30天，试验取得100%的器械急性成功率，未报告死亡、卒中、心肌梗死或支架血栓，可评估受试者的支架均保持通畅。
市场方面，美国每年开展的 TCAR 手术超过35,000例。公司估计，TCAR 与 CAS 合计每年约75,000例颈动脉支架手术；TCAR 适应症获批使 CGuard Prime 平台的可触达市场翻倍。
公司首席执行官 Marvin Slosman 表示，这项批准是公司的重要里程碑，预计将成为近期增长动力。公司同时在推进自有下一代经颈动脉神经保护系统 SwitchGuard，其关键试验 CGUARDIANS III 正在入组；SwitchGuard 目前为研究性器械，尚未在美国上市销售。（来源：InspireMD公司）
InspireMD Wins FDA Approval for CGuard Prime TransCarotid Stent System, Doubling Its U.S. Addressable Market
InspireMD, Inc. (Nasdaq: NSPR), developer of the CGuard Prime carotid stent system for the prevention of stroke, announced on November 12, 2026, in Miami, Florida, that the U.S. Food and Drug Administration (FDA) has approved the company's Premarket Approval (PMA) supplement for the CGuard Prime TransCarotid Stent System for use in transcarotid artery revascularization (TCAR) procedures.
The approved system, which features an 80 cm delivery system, is used in conjunction with an embolic protection system specified in the labeling. Its self-expanding nitinol stent is covered by MicroNet, a permanent protective micromesh. The company said the approval gives physicians performing TCAR procedures access to the CGuard Prime stent, making InspireMD the first and only company to approach carotid revascularization with both CAS and TCAR delivery options, according to the company.
The approval is supported by the CGUARDIANS II pivotal trial, a prospective, multicenter, single-arm U.S. study that enrolled 50 pivotal patients across 11 investigational sites in a high-surgical-risk population, using the FDA-cleared ENROUTE Transcarotid Neuroprotection System. At 30 days, the study achieved 100% acute device success, with no deaths, strokes, myocardial infarctions, or stent thrombosis reported, and complete stent patency observed in evaluable subjects.
More than 35,000 TCAR procedures are performed annually in the United States. Together, TCAR and CAS represent approximately 75,000 annual carotid stenting procedures, based on company estimates, and the approved TCAR indication doubles the CGuard Prime platform's total addressable market.
Chief Executive Officer Marvin Slosman called the approval a major milestone and an expected near-term growth driver. The company is also evaluating its next-generation SwitchGuard transcarotid neuroprotection system in the CGUARDIANS III pivotal trial, which is currently enrolling; SwitchGuard is an investigational device and is not available for sale in the United States. (Source: InspireMD, Inc)
来源：InspireMD公司
发布：GSM·美国（发布链接）
图片来源：图：美国食品药品监管局 FDA 总部大楼（联邦固定图库）。 / Photo: U.S. Food and Drug Administration headquarters building (federal asset library).
GSM Global · 本篇英文版 English edition of this story
