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InspireMD Initiates Voluntary U.S. Recall of CGuard® Prime 135 cm Carotid Stent Delivery System
- Strong clinical demand continues in Q1 2026 with global year-over-year unit sales growth of 53% and quarter-over-quarter U.S. unit sales growth of 34% - - FDA approval anticipated with U.S. market availability of original CGuard delivery system in the third quarter of 2026 - - Continuing to anticipate FDA approval of CGuard Prime 80 cm for TCAR procedures during 2H 2026 - MIAMI, May 01, 2026 (GLOBE NEWSWIRE) -- InspireMD, Inc. (Nasdaq: NSPR) (“InspireMD,” or the “Company”), developer of the CG
About this update from Inspiremd Inc.
[{"type":"image","alt":"InspireMD Inc.","displaySize":"","headline":null,"caption":"InspireMD Inc.","className":"","disableSlideshowImg":false,"size":{"original":{"width":178,"height":24,"url":"https://media.zenfs.com/en/globenewswire.com/291f6cac2fbf0704acd61c88071899d5"},"resized":{"url":"https://s.yimg.com/ny/api/res/1.2/2oTbfyHon8MiI_bmdzR_wQ--/YXBwaWQ9aGlnaGxhbmRlcjt3PTIxMDtoPTI4/https://media.zenfs.com/en/globenewswire.com/291f6cac2fbf0704acd61c88071899d5","width":178,"height":24}},"lazy":false},{"type":"text","content":"- Strong clinical demand continues in Q1 2026 with global year-over-year unit sales growth of 53% and quarter-over-quarter U.S. unit sales growth of 34% - ","length":154,"tagName":"p"},{"type":"text","content":"- FDA approval anticipated with U.S. market availability of original CGuard delivery system in the third quarter of 2026 - ","length":122,"tagName":"p"},{"type":"text","content":"- Continuing to anticipate FDA approval of CGuard Prime 80 cm for TCAR procedures during 2H 2026 -","length":98,"tagName":"p"},{"type":"text","content":"MIAMI, May 01, 2026 (GLOBE NEWSWIRE) -- InspireMD, Inc. (Nasdaq: NSPR) (“InspireMD,” or the “Company”), developer of the CGuard® Prime carotid stent system for the prevention of stroke, today announced that, in consultation with the U.S. Food and Drug Administration (“FDA”), the Company has initiated a voluntary recall in the U.S. for its CGuard® Prime 135 cm carotid stent delivery system.","length":392,"tagName":"p"},{"type":"text","content":"The Company acted after determining during a controlled launch that the technical success of the delivery system during carotid artery stenting (“CAS”) procedures has not met performance expectations. This action is voluntary with no implications for the safety of patients who have previously received the CGuard stent.","length":320,"tagName":"p"},{"type":"text","content":"This voluntary action pertains specifically to the CGuard Prime 135 delivery system, and does not include the CGuard stent implant, which continues to generate unmatched clinical outcomes, including the lowest major adverse event rates and most durable stroke prevention among CAS carotid interventions.","length":303,"tagName":"p"},{"type":"text","content":"InspireMD anticipates FDA approval for its original CGuard stent delivery system for CAS procedures in the U.S. in the third quarter ...