FDA grants premarket approval to carotid stenting system for stroke

The FDA has granted premarket approval to the Neuroguard IEP System, a novel stenting system intended to ease the process for individuals with stroke, according to the manufacturer.

Contego Medical said in a press release that the system, which is comprised of a high-performance stent, integrated dilation balloon and integrated filters, aims to reduce the steps necessary to place the stent, ensuring greater safety by embolic capture.

"The idea for the Neuroguard IEP System started with a fundamental question: How can we improve outcomes and reduce procedural complexity for patients undergoing carotid revascularization?,” Contego Medical founder and CEO Ravish Sachar, MD, told Healio in an email.

According to data cited in the release, use of the Neuroguard IEP in the PERFORMANCE I and PERFORMANCE II IDE clinical trials resulted in significantly low event rates related to the carotid arteries; there were no major strokes or neurologic deaths, as well as no record of stent thrombosis at both 30 days and 1 year.

“The key discovery that drove the innovation is that the greatest risk is procedural, particularly during balloon dilation and stenting,” Sachar told Healio. “With the approval, we are ready for more physicians to have access to this standard of care-changing technology.”