The company said it initiated a voluntary recall for the system. After a controlled launch, the company determined that the technical success of the delivery system during carotid artery stenting procedures failed to meet performance expectations. Its action has no implications on the safety of patients already with an implanted CGuard stent.
According to a news release, the action specifically pertains to the delivery system, not the stent implant itself. The company designed CGuard Prime embolic prevention stent (EPS) system to prevent stroke.
InspireMD launched CGuard Prime in the U.S. in July 2025 after receiving FDA premarket approval (PMA) the previous month. To date, it reports 70,000 successful cases worldwide, including the majority of clinical cases in its CGUARDIANS clinical trial.
Now, the company plans to implement design improvements to the delivery system. It anticipates FDA approval in the first half of 2027. InspireMD also anticipates FDA approval later this year for its CGuard Prime 80 cm carotid stent delivery system for transcarotid artery revascularization (TCAR) procedures. It also hopes for FDA clearance of its SwitchGuard neuroprotection system for TCAR in the second half of 2027.
With the recall, InspireMD withdrew its 2026 revenue guidance.
“Our continued strong unit sales growth worldwide in the first quarter 2026 reflects significant demand for this novel stent technology with our best-in-class CGuard implant,” stated Marvin Slosman, CEO. “However, the controlled launch of CGuard Prime in the U.S. has revealed opportunities to improve the technical performance of the delivery system,” continued Mr. Slosman. “As a result, we have taken the proactive step to pause commercialization of the CGuard Prime delivery system to implement the necessary enhancements. This voluntary action reflects our unwavering commitment to providing our customers with the highest quality carotid stent platform on the market, while minimizing market disruptions and achieving the optimal physician satisfaction and patient safety for which we are known.”
InspireMD shares advances on another product
With high hopes for SwitchGuard, the company also announced today that it received FDA investigational device exemption (IDE) approval to conduct the CGUARDIANS III pivotal trial of the system.
SwitchGuard includes next-generation enhancements from the company’s previous IDE for use with CGuard P rime 80cm for TCAR.
“The approval of our CGUARDIANS III IDE represents a meaningful advancement in our quest to offer the full TCAR tool kit leveraging our best-in-class CGuard Prime 80 cm stent platform for unmatched stroke prevention and carotid disease management,” said Slosman. “We look forward to the efficient execution of this important study as we target U.S. commercial launch of the SwitchGuard NPS in 2027, if approved.”
