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)
Source: InspireMD, Inc
Published by GSM · USA (original Chinese edition)
Photo: 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).
