InspireMD today announced that the first patient has been enrolled in the CGUARDIANS III pivotal study of its SwitchGuard neuro protection system (NPS), for use with its CGuard Prime 80cm stent platform, in transcarotid artery revascularisation (TCAR) procedures. The patient was enrolled by Patrick Muck at Good Samaritan Hospital in Cincinnati, USA.
A press release notes that Muck and Patrick Geraghty (Washington University School of Medicine, St Louis, USA) have agreed to act as global co-principal investigators for the CGUARDIANS III trial.
“Building on the strong clinical momentum established by the CGUARDIANS II study of CGuard Prime 80cm with FDA [US Food and Drug Administration]-cleared neuro protection systems, we are excited to advance into the next phase of innovation with the CGUARDIANS III study of the SwitchGuard NPS,” said Muck. “SwitchGuard represents a natural evolution of InspireMD’s commitment to achieving the best clinical outcomes in carotid artery disease, particularly in the growing adoption of TCAR procedures. By combining the proven performance of CGuard Prime with next-generation neuro protection, we aim to further enhance procedural safety while reducing stroke risk and providing physicians with a comprehensive solution tailored to the needs of their patients. We believe SwitchGuard, if approved, has the potential to set a new standard of care in carotid revascularisation.”
CGUARDIANS III is a prospective, multicentre, single-arm pivotal study that will enrol approximately 103 participants. The objective of the study is to evaluate the safety and efficacy of the SwitchGuard NPS in providing cerebral embolic protection during TCAR procedures using the CGuard Prime 80cm stent system for the treatment of carotid artery stenosis in patients at high risk for complications from carotid endarterectomy (CEA).
