InspireMD, Inc. (Nasdaq: NSPR) has announced that the U.S. Food and Drug Administration (FDA) has approved its Investigational Device Exemption (IDE) application to commence the CGUARDIANS II pivotal study. This study will evaluate the CGuard Prime 80cm Carotid Stent System during transcarotid revascularization (TCAR) procedures, marking a significant step in the company's mission to prevent stroke and manage carotid disease. The approval paves the way for potential U.S. commercial expansion and market leadership.
The CGUARDIANS II trial will assess the safety and efficacy of the CGuard Prime stent in TCAR procedures, a minimally invasive approach to prevent strokes. The study aims to facilitate approval of the CGuard Prime for TCAR-specific applications. Key investigators, Patrick Geraghty, M.D., professor of surgery and radiology at Washington University School of Medicine in St. Louis, MO, and Patrick Muck, M.D., program director and chief of vascular surgery at Good Samaritan Hospital in Cincinnati, OH, will lead the trial.
CGuard Prime Stent System
The CGuard Embolic Prevention Stent System (EPS) incorporates InspireMD’s MicroNet technology, designed to deliver strong acute results and durable, stroke-free long-term outcomes. The company believes this technology can become the industry standard for carotid stenting. The CGuard EPS system received CE mark earlier this year.
Marvin Slosman, CEO of InspireMD, emphasized the importance of the FDA's approval. "The approval of our CGUARDIANS II IDE is an important milestone and a significant step forward in our mission to serve the broadest range of physician and patient needs with a comprehensive set of tools that can deliver our best-in-class carotid stent system, CGuard Prime, for both CAS and TCAR procedures," said Slosman. "The CGUARDIANS II study is intended to facilitate approval of the use of CGuard Prime in an optimized TCAR version and indication."
Future Developments
InspireMD is also advancing the development of its next-generation TCAR Neuroprotection System, SwitchGuard NPS. Once approved, this system will complement the CGuard platforms, further solidifying the company's position in the market.
"Each of these initiatives helps pave the way, once approved, for us to initiate commercial sales and strive for market leadership in the United States," Slosman added. "Our mission to improve stroke prevention and carotid disease management with our CGuard platforms continues as we build our company toward U.S. expansion and global success."
