Contego Medical has announced enrollment of the first patient in the prospective, multicenter 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 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, MD, chairman of vascular surgery at the Cleveland Clinic in Cleveland, Ohio, 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, minimizing catheter exchanges and improving treatment efficiency. In addition, Neuroguard utilizes 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.
