Enrollment has begin in the PERFORMANCE I Trial, a clinical trial designed to evaluate the safety and feasibility of the Neuroguard IEP® 3-in-1 Carotid Stent and Post-Dilation Balloon System with Integrated Embolic Protection announced today by Contego Medical. The Neuroguard IEP System is designed to treat clinically significant carotid artery stenosis, further expanding Contego Medical’s portfolio of neurovascular solutions.
Prof. Saško Kedev, M.D., Ph.D., of University Clinic of Cardiology in Skopje, Macedonia treated the first patient enrolled in the PERFORMANCE I Trial. “We are pleased to initiate this trial evaluating the Neuroguard IEP System, the first of its kind for carotid stenting,” remarked Prof. Kedev. “Protection from stroke is key during carotid artery interventions. This 3-in-1 system includes a novel state-of-the-art carotid stent and provides uninterrupted micro-embolic protection during the most vulnerable stages of the procedure. I am very impressed with the performance of all aspects of the device.”
The Neuroguard IEP System contains a novel, next-generation nitinol stent, a pre-positioned post-dilation balloon and an integrated microembolic filter with 40 μm pores. The stent has a closed-cell design for optimal balance of radial strength and flexibility. The stent is flared at both ends to facilitate ideal wall apposition in tortuous anatomy. The integrated filter is designed to capture both macro- and micro-emboli during the entire intervention. All components are mounted on a 6 French delivery system.
A new era in carotid artery stenting: Ravish Sachar, M.D., CEO and Founder of Contego Medical comments, “The Neuroguard IEP System signals a new era in carotid artery stenting. “By combining a novel stent, post-dilation balloon, and embolic filter onto the same catheter, we expect to dramatically impact this procedure by improving ease of use, reducing interventional time, and maximizing embolic protection. The Neuroguard IEP System represents Contego’s third innovation in their commitment to deliver endovascular devices designed to improve outcomes without increasing complexity.”