InspireMD Announces First Patient Enrolled in CGUARDIANS II Pivotal Study

InspireMD, Inc., a leading medical technology company, recently disclosed in an 8-K filing with the Securities and Exchange Commission that the first patient has been successfully enrolled in its CGUARDIANS II clinical trial. This study aims to evaluate the application of the CGuard Prime Carotid Stent System in patients undergoing carotid artery stenting through the Transcarotid Artery Revascularization (TCAR) approach. The patient enrollment was conducted by Dr. Patrick Muck at Good Samaritan Hospital in Cincinnati, Ohio, who is serving as both the site principal investigator and co-lead investigator for the study.

Marvin Slosman, the Chief Executive Officer of InspireMD, expressed enthusiasm about the progress, stating, “As we approach potential FDA approval of CGuard Prime with a CAS indication in the first half of next year, we are thrilled to have initiated the CGUARDIANS II study that, if successful, will address an ever-expanding TCAR market of roughly 30,000 procedures performed in the U.S. this year.” The company’s focus remains on providing physicians and patients with innovative solutions that deliver optimal clinical outcomes.

Dr. Patrick Muck also shared his perspective on the study, emphasizing the importance of prior data from the C-GUARDIANS PMA and the significant potential of the CGuard Prime Carotid Stent System in enhancing patient care through superior clinical results. The study, which is a prospective, multi-center, single arm pivotal trial, aims to enroll a minimum of 50 evaluable patients to assess the acute device success and technical success of the CGuard Prime in conjunction with an FDA-cleared TCAR neuro-protection system.

Investors and stakeholders can find more information about InspireMD and its innovative products on the company’s website. The company continues to strive for excellence in the medical technology industry through its commitment to delivering exceptional outcomes for patients undergoing carotid stenting procedures.

The 8-K filing also included a press release, detailing the milestone achievement in the CGUARDIANS II study. The company remains dedicated to advancing medical solutions and enhancing patient care through its groundbreaking technologies.

The article is based on the information disclosed in the 8-K filing submitted to the Securities and Exchange Commission by InspireMD. Please refer to the official filing and company’s website for further details and updates on the CGUARDIANS II study and the CGuard Prime Carotid Stent System.

This article was generated by an automated content engine and was reviewed by a human editor prior to publication. For additional information, read InspireMD’s 8K filing here.

InspireMD Company Profile

InspireMD, Inc, a medical device company, focuses on the development and commercialization of MicroNet stent platform technology for the treatment of vascular and coronary diseases in Europe, Latin America, the Middle East, and Asia Pacific. The company offers CGuard carotid embolic prevention system (EPS) for use in carotid artery applications; CGuard Prime Stent System, a mesh-covered self-expanding carotid stent; and SwitchGuard NPS, a non-invasive transcarotid artery revascularization device; as well as treating acute stroke with tandem lesions.