Contego’s Neuroguard IEP PERFORMANCE II Carotid Stent Trial Completes Enrollment

November 14, 2022—Contego Medical, Inc. announced that enrollment of the PERFORMANCE II clinical trial has been completed.

According to the company, PERFORMANCE II is evaluating the safety and effectiveness of the company’s Neuroguard IEP three-in-one carotid stent and postdilation balloon system with integrated embolic protection (IEP). Neuroguard IEP is designed to treat clinically significant carotid artery stenosis while improving procedural safety by integrating the stent, balloon, and an embolic filter in a single device.

The prospective, multicenter, single-arm, open-label study of the treatment of carotid artery stenosis in patients at high risk for carotid endarterectomy enrolled 305 patients at 32 sites in the United States and Europe. The results of the study will be used to support an FDA premarket approval application. The company announced European CE Mark approval of the device in April 2021.

The principal investigators of the study are William Gray, MD, from Main Line Health in Wynnewood, Pennsylvania, and Ralf Langhoff, MD, from Sankt Gertrauden Hospital in Berlin, Germany.

“The Neuroguard IEP technology may offer significant benefits to patients suffering from severe carotid stenosis, specifically with the potential to lower the embolic burden and overall stroke rates,” commented Dr. Gray in Contego’s press release.

Christopher Metzger, MD, from Holston Valley Medical Center in Kingsport, Tennessee, who is the lead enroller in the trial, added “The Neuroguard IEP system combines a truly innovative stent design with a multifunction delivery platform for advanced protection from stroke, while reducing the number of catheter exchanges needed to complete the procedure. Additionally, it has outstanding conformability for a closed-cell stent, allowing the advantages of this stent system in a wide variety of carotid anatomies.”

Contego Medical’s Neuroguard IEP system guards against stroke by integrating a next-generation stent, a prepositioned post-dilation balloon, and a microembolic filter. The stent has a closed-cell design with the company’s FlexRing technology for an optimal balance of plaque coverage, radial strength, and flexibility. The company stated that the integrated 40-μm filter is designed to capture more micro-embolic debris than traditional filters.

In October, results from the company’s PERFORMANCE I study were published by Dr. Langhoff, et al online ahead of print in Catheterization and Cardiovascular Intervention. The study was composed of 67 patients enrolled at nine European sites with 1-year follow-up. The overall success rate was 100%. The PERFORMANCE I investigators concluded, “Results from the study demonstrate that the Neuroguard IEP system is safe and feasible with a stroke/death rate of 0% at 30 days.” The company announced the commencement of enrollment in PERFORMANCE I in March 2018.