Contego’s Neuroguard IEP System Used in First Commercial Procedures

December 19, 2024—Contego Medical announced the first commercial procedures were performed with the company’s Neuroguard IEP system.

According to Contego, Neuroguard IEP is a three-in-one device combining a high-performance carotid stent, an integrated dilation balloon, and an integrated filter. The company announced FDA approval for the device in October 2024.

The first patients were treated by John Gaughen, Jr., MD, an interventional neuroradiologist at Centra Medical Group in Lynchburg, Virginia, and by Srinivas Attanti, MD, an interventional cardiologist at the University of Florida Health Leesburg Hospital in Leesburg, Florida.

“The Neuroguard system is very easy to use and streamlines the steps for treating our patients with carotid artery disease,” commented Dr. Gaughen in Contego’s press release. “I believe this innovation will reduce the risk of stroke during and after carotid artery stenting procedures.”

Dr. Attanti added, “The pores on the integrated filter are much smaller than those on traditional technology, improving stroke protection for our patients.”

The company stated that clinical studies of the Neuroguard IEP system, including the PERFORMANCE I trial and the PERFORMANCE II investigational device exemption trial, consistently reported low event rates: zero major strokes, zero neurologic deaths, and zero stent thromboses at up to 2-year follow-up.

Results from the PERFORMANCE I study were published by Ralf Langhoff, MD, et al in Catheterization and Cardiovascular Interventions (2022;100:1090-1099).

Contego noted that the PERFORMANCE II study showed that the Neuroguard IEP system meaningfully reduced the risk of procedural and long-term stroke among patients with carotid artery disease. William A. Gray, MD, presented the PERFORMANCE II data at VIVA24, the 22nd annual Vascular InterVentional Advances annual vascular education symposium held by The VIVA Foundation on November 3-6 in Las Vegas, Nevada.