InspireMD and North American Science Associates (NAMSA) today announced that, pursuant to a previously announced strategic outsourcing partnership, the companies are working together to conduct the CGUARDIANS II pivotal study of InspireMD’s CGuard Prime 80cm carotid stent system for use in transcarotid artery revascularisation (TCAR) procedures.
Marvin Slosman, chief executive officer of InspireMD, commented: “With more than 30,000 TCAR procedures performed in the US each year, TCAR is a rapidly growing procedure that represents a significant potential expansion of our addressable market and the lynchpin of our effort to serve the broadest patient population by supporting both CAS [carotid artery stenting] and TCAR carotid stenting procedures. We are very pleased to be working with NAMSA and leveraging their vascular clinical and regulatory expertise to execute this important study as efficiently as possible.”
Adam Saltman, NAMSA’s chief medical officer, added: “The CGUARDIANS II study is a well-designed pivotal study that will evaluate the safety and effectiveness of the TCAR procedure as performed with the novel CGuard Prime stent platform with an FDA [US Food and Drug Administration]-authorised embolic protection device. CGUARDIANS II is an excellent example of how NAMSA and our clinical leaders collaborate and provide support by leveraging our more-than-four-decades of investigative experience in carotid disease in general, and carotid artery stenting in particular, most recently through a TCAR approach. We look forward to continuing our work with the InspireMD team and their advisors in this and other investigations of novel therapies.”
On 9 December 2024, InspireMD announced that the first patient had been enrolled into the CGUARDIANS II clinical study.
A press release notes that CGUARDIANS II is a prospective, multicentre, single-arm pivotal study that aims to enrol a minimum of 50 evaluable patients. The objective of this study is to evaluate acute device success and technical success of the CGuard Prime when used in conjunction with an FDA-cleared TCAR neuro-protection system in patients at high risk for adverse events from carotid endarterectomy.
