Contego Medical Releases One-Year Outcomes From Carotid Stent Trial

Contego Medical Inc. is touting positive clinical results from the PERFORMANCE II carotid stent trial, a prospective, multicenter study evaluating the safety and effectiveness of the Neuroguard IEP System in 305 patients at 40 clinical sites.
 
“The one-year event rates in the PERFORMANCE II study are the lowest ever reported in any adequately powered, prospective, multicenter study of any type of carotid artery revascularization, regardless of patient risk,” said Dr. William Gray, System Chief, Division of Cardiovascular Diseases, Main Line Health and co-national principal investigator of the PERFORMANCE II trial. “These results can elevate the standard of care for patients with severe carotid artery disease who are deemed appropriate for intervention by delivering demonstrated best-in-class stroke protection.”
 
In the PERFORMANCE II study, the reported 30-day stroke rate is 1.31% in an intention-to-treat analysis and 0.98% in a per-protocol analysis, with no major strokes or contralateral strokes, and all patients returning to baseline neurologically within 30 days. At the one-year follow-up (all stroke within 30 days and ipsilateral stroke between day 31 and 12 months), the reported stroke rate is 1.68% in an intention-to-treat analysis and 1.35% in a per-protocol analysis. No major strokes or neurological deaths occurred in the study.

“Our mission is to provide a new class of products which improve patient outcomes and procedural efficiency,” said Stacy Enxing Seng, operating partner at Lightstone Ventures and Contego Medical board chairman. “The IEP platform, as demonstrated in the PALADIN, PERFORMANCE I and PERFORMANCE II studies, meaningfully advances stroke protection for patients. For physicians, it offers reduced catheter exchanges and improved efficiency with a three-in-one design, combining the Neuroguard stent, balloon, and filter all in one device.”
 
The Neuroguard IEP System leverages Contego Medical’s clinically proven integrated embolic protection (IEP) technology, a platform with a micro-filter integrated on the delivery catheter. It is designed to deliver added safety where it matters most—during stent placement and balloon dilation. The micro-filter with 40µm pores captures the micro-emboli other protection mechanisms don’t, giving physicians the procedural confidence that comes with advanced stroke protection when treating patients. The Neuroguard closed cell stent utilizes FlexRing technology, providing optimized radial strength and flexibility while leveraging nitinol’s proven long-term material performance.
 
“The change in coverage by the Centers for Medicare & Medicaid Services (CMS) increases patient access to carotid artery treatment. We are committed to providing the most advanced and clinically proven technology to all patients and their physicians in the vascular community,” Contego Medical CEO Dr. Ravish Sachar stated.   

In addition to the PERFORMANCE II study in which Neuroguard was placed via transfemoral or transradial access, the PERFORMANCE III study is currently enrolling patients to evaluate the same stent placed via direct transcarotid access.
 
Contego Medical Inc. develops integrated, multi-functional products is designed to improve patient outcomes and procedural efficiency in treating carotid and peripheral vascular disease. Its patented Neuroguard IEP System is currently limited by federal U.S. law to investigational use only in the PERFORMANCE II study and PERFORMANCE III study. More than 3,000 patients have been treated with Contego Medical products to date.