Contego Medical, a medical device company focused on endovascular medicine, has enrolled the first patient in the PERFORMANCE 2 carotid stenting trial.
The clinical trial is aimed at evaluating the safety and effectiveness of the Neuroguard IEP 3 in 1 carotid stent and post-dilation balloon system with integrated embolic protection.
The Neuroguard IEP System contains an advanced nitinol stent, a pre-positioned post-dilation balloon and an integrated microembolic filter with 40μm pores.
Contego has designed the system to treat clinically significant carotid artery stenosis and improves procedural safety by integrating stent, balloon and filter technology all in a single device.
The first patient was treated by James Zidar from University of North Carolina Rex Hospital in Raleigh, North Carolina.
Zidar said:“Our team is excited to participate in the PERFORMANCE II Trial and to have enrolled the first patient. 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.”
PERFORMANCE 2 clinical study will enrol more than 300 patients in the US and Europe
PERFORMANCE 2 is a multicentre single-arm, open label clinical study designed to evaluate the treatment of carotid artery stenosis in patients at high-risk for adverse events following carotid endarterectomy (CEA).
The clinical study will enrol more than 300 patients at approximately 40 sites in the US and Europe, and is planned to be conducted under a US Investigational Device Exemption (IDE) through the US Food and Drug Administration (FDA).
Contego said that the results from the PERFORMANCE 2 study will be used to support a pre-market approval application with FDA.
Contego Medical CEO and founder Ravish Sachar said: “The Neuroguard IEP System represents a next generation stent and delivery system designed to enhance safety and reduce procedural complexity.
“Our disruptive 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.”
