Contego Medical has announced the successful completion of the first commercial cases with its newly US Food and Drug Administration (FDA)-approved Neuroguard IEP system.
A press release notes that John Gaughen Jr, an interventional neuroradiologist at Centra Medical Group (Lynchburg, USA), and Srinivas Attanti, an interventional cardiologist at the University of Florida Health Leesburg Hospital (Leesburg, USA), treated the first patients.
“The Neuroguard system is very easy to use and streamlines the steps for treating our patients with carotid artery disease. I believe this innovation will reduce the risk of stroke during and after carotid artery stenting procedures,” said Gaughen. Attanti added: “The pores on the integrated filter are much smaller than those on traditional technology, improving stroke protection for our patients.”
Contego Medical highlights clinical studies of the Neuroguard IEP system, including the PERFORMANCE I trial and PERFORMANCE II investigational device exemption (IDE) trial, that have consistently reported “unprecedented” low event rates—zero major strokes, zero neurologic deaths, and zero stent thromboses—at up to two-year follow-up.
“When we started Contego, we always had our sights set on this day. The introduction of the Neuroguard IEP system ushers in a new era for treating patients with carotid artery disease, providing a level of safety and confidence that was previously unmatched,” said Ravish Sachar, Contego Medical’s chief executive officer and founder.
