PERFORMANCE II is a prospective, multicenter single-arm, open label study for the treatment of carotid artery stenosis in subjects at elevated risk for adverse events following carotid endarterectomy (CEA). The study will enroll over 300 patients at over 40 sites in the United States and Europe, and is being conducted under a U.S. Investigational Device Exemption (IDE) through the U.S. Food and Drug Administration (FDA). Results of the study will be used to support an FDA Pre-Market Approval application.
"Our team is excited to participate in the PERFORMANCE II Trial and to have enrolled the first patient," remarked Dr. Zidar. "Carotid stenting has many established benefits, including minimal invasiveness and faster patient recovery than CEA. The main risk to patients is procedural stroke, which is why appropriate embolic filtration is so critical. The Neuroguard IEP System provides a state-of-the-art stent and micro-embolic filter on the same catheter, reducing device exchanges, which can reduce risk and improve efficiency. I found both stent and filter deployment to be simple and easy, providing confidence throughout the procedure."
The Neuroguard IEP System contains a novel, next-generation nitinol stent, a pre-positioned post-dilation balloon and an integrated microembolic filter with 40 μm pores. The stent has a closed-cell design for optimal balance of radial strength and flexibility. The stent features an asymmetrical hourglass design that is flared at both ends to facilitate ideal wall apposition in tortuous anatomy. The integrated filter is designed to capture both macro- and micro-emboli during the entire intervention.
Stacy Enxing Seng, venture partner of Lightstone Ventures and board chairman of Contego Medical, commented, "Our Integrated Embolic Protection technology is poised to transform carotid artery stenting procedures by uniquely incorporating treatment and protection onto the same catheter."
"The Neuroguard IEP System represents a next generation stent and delivery system designed to enhance safety and reduce procedural complexity," said Ravish Sachar, M.D., CEO and founder of Contego Medical. "Our platform technology is aimed at providing the highest quality interventional solutions while providing seamless, anatomically-designed protection. The initiation of the PERFORMANCE II trial reinforces our commitment to this cause."