Contego Medical has announced enrolment of the first patient in the prospective, multicentre PERFORMANCE III trial aimed at further evaluating the safety and effectiveness of the Neuroguard integrated embolic protection (IEP) direct system—a carotid stent system designed for direct transcarotid access.
The study is a follow-on to the fully enrolled PERFORMANCE II study of the Neuroguard IEP system, which was conducted to evaluate the stent placed via percutaneous transfemoral or transradial access. Both PERFORMANCE II and PERFORMANCE III are being conducted under an investigational device exemption (IDE) through the US Food and Drug Administration (FDA).
“We look forward to studying the Neuroguard IEP direct system and determining its potential as a new option for patients with carotid artery stenosis,” said Sean Lyden (Cleveland Clinic, Cleveland, USA), co-national principal investigator of the PERFORMANCE III trial.
According to a company press release, the Neuroguard IEP and Neuroguard IEP direct systems leverage Contego’s IEP technology, a “unique” platform with a microfilter integrated on the delivery catheter, designed to provide added safety where it matters most—during stent placement and balloon dilation. The microfilter captures the micro-emboli that other protection mechanisms do not, giving physicians the procedural confidence that comes with advanced stroke protection in the treatment of their patients, the release adds.
The Neuroguard IEP direct system also includes a novel, single-access point blood flow reversal system specifically designed for direct transcarotid access. The system is a three-in-one catheter with the stent, balloon and microfilter all in one device, minimising catheter exchanges and improving treatment efficiency. In addition, Neuroguard utilises FlexRing stent technology, which Contego says provides the best properties of both open- and closed-cell stents while leveraging the proven, long-term material performance of nitinol.
“I have no doubt the Neuroguard IEP direct system will elevate the standard of care for carotid artery stenosis patients,” said Robert Mendes (University of North Carolina [UNC] Rex Hospital, Raleigh, USA), who treated the first patient in the PERFORMANCE III study. “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 optimised direct access kit to the blood flow reversal system, to the added IEP. It is a three-in-one leap forward in catheter design.”
