Contego Medical’s Neuroguard IEP Direct System Studied in PERFORMANCE III Trial

October 6, 2023—Contego Medical, Inc. announced enrollment of the first patient in the PERFORMANCE III trial evaluating the safety and effectiveness of the company’s Neuroguard integrated embolic protection (IEP) Direct system, a carotid stent system designed for direct transcarotid access.

The prospective, multicenter PERFORMANCE III trial of the Neuroguard IEP Direct system follows the fully enrolled PERFORMANCE II study of the Neuroguard IEP system to evaluate the same stent placed via percutaneous transfemoral or transradial access. Both the PERFORMANCE II and PERFORMANCE III studies are being conducted under an FDA investigational device exemption.

“We look forward to studying the Neuroguard IEP Direct system and determining its potential as a new option for patients with carotid artery stenosis,” commented Sean Lyden, MD, in the company’s press release. Dr. Lyden, who is Chairman of the Department of Vascular Surgery at Cleveland Clinic in Cleveland, Ohio, serves as Conational Principal Investigator of the PERFORMANCE III trial.

According to the company, the Neuroguard IEP and Neuroguard IEP Direct systems leverage Contego Medical’s IEP technology, which features a microfilter integrated on the delivery catheter to provide added safety during stent placement and balloon dilation. The microfilter captures the microemboli for advanced stroke protection.

The Neuroguard IEP Direct system also includes a single-access-point blood flow reversal system designed for direct transcarotid access.

Contego Medical noted that the Neuroguard system is a three-in-one catheter with the stent, balloon, and microfilter in one device, which minimizes catheter exchanges and improves treatment efficiency. Neuroguard also utilizes the company’s FlexRing stent technology, which provides the best properties of both open- and closed-cell stents while leveraging the long-term material performance of nitinol.

Robert Mendes, MD, who is a vascular surgeon at the University of North Carolina Rex Hospital in Raleigh, North Carolina, treated the first patient in the PERFORMANCE III study.

“I have no doubt the Neuroguard IEP Direct system will elevate the standard of care for carotid artery stenosis patients,” stated Dr. Mendes in Contego Medical’s press release. “Its safety is unmatched, and it is simple and efficient to operate. This is an across-the-board advancement in technology in every aspect of the system, from the optimized direct access kit to the blood flow reversal system to the added IEP. It’s a three-in-one leap forward in catheter design.”

The company advised that the Neuroguard IEP and Neuroguard IEP Direct systems are currently limited by Federal United States law to investigational use only in the PERFORMANCE II study and the PERFORMANCE III study, respectively. The Neuroguard IEP system has received European CE Mark approval.