Contego Medical recently announced that it received CE mark approval for its Neuroguard IEP 3-in-1 carotid stent system and post-dilation balloon system with integrated embolic protection.
The system has a nitinol stent, a pre-positioned post-dilation balloon and a microembolic filter with 40 μm pores. Its closed-cell stent is designed for optimal performance across radial strength, vessel coverage and flexibility. It also has an integrated filter that is designed to capture both macro- and micro-emboli during a procedure.
Contego Medical’s Neuroguard IEP System is indicated for adult patients with clinically significant carotid artery stenosis requiring stenting.
“CE Marking of the Neuroguard IEP System is an important milestone for Contego Medical and allows us to bring the remarkable safety and performance benefits of the Neuroguard stent to patients in Europe,” CEO and founder Ravish Sachar said in a news release. “We anticipate launching the product in select countries as well initiating a post-marketing clinical study in the coming months.”
Neuroguard was first evaluated in the Performance I clinical trial that was conducted in nine European sites and included 67 patients with a one-year follow-up. The study found an overall success rate of 100% with a stroke and death rate of 0% at 30 days.
“Receipt of CE Mark approval for the Neuroguard IEP System is a significant achievement for the Contego Medical team and represents a multi-year investment in innovative product development and high-quality clinical research. I believe that the Neuroguard IEP System has the performance and ease of use to become the standard of care in the treatment of carotid artery disease,” Contego’s medical board chair Stacy Enxing Seng said.