PERFORMANCE I Trial Begins for Contego Medical's Neuroguard IEP Carotid System

March 7, 2018—Contego Medical, LLC announced the beginning of enrollment in the PERFORMANCE I clinical trial, which is designed to evaluate the safety and feasibility of the company's Neuroguard IEP, which is a three-in-one carotid stent and postdilation balloon system with integrated embolic protection (IEP). The Neuroguard IEP system is designed to treat clinically significant carotid artery stenosis.

The first patient enrolled in the PERFORMANCE I trial was treated by Professor Saško Kedev, MD, of University Clinic of Cardiology in Skopje, Macedonia. In the company's announcement, Prof. Kedev commented, "We are pleased to initiate this trial evaluating the Neuroguard IEP system, the first of its kind for carotid stenting. Protection from stroke is key during carotid artery interventions. This three-in-one system includes a novel state-of-the-art carotid stent and provides uninterrupted microembolic protection during the most vulnerable stages of the procedure. I am very impressed with the performance of all aspects of the device."

According to the company, the Neuroguard IEP system is composed of a next-generation nitinol stent, a prepositioned postdilation balloon, and an integrated microembolic filter with 40-μm pores. The stent's closed-cell design balances radial strength and flexibility. The stent is flared at both ends to facilitate wall apposition in tortuous anatomy and the device's integrated filter is designed to capture both macro- and microemboli during the entire intervention. All components are mounted on a 6-F delivery system.

The Neuroguard IEP system is an investigational device and is not commercially available in any market, advised Contego Medical.