Medtronic (NYSE: MDT) today announced the full U.S. rollout of the Neuroguard IEP system, a carotid stent and embolic protection device.
The launch follows a limited market release and builds on Medtronic’s exclusive U.S. distribution agreement with the device’s developer Contego Medical.
Neuroguard IEP combines a nitinol stent, dilation balloon and integrated filter in a single device designed to reduce the risk of stroke during carotid artery stenting. The integrated 40-micron filter captures microembolic debris that can be released during balloon dilation, which is a key source of stroke risk in carotid procedures.
“With this launch, we are setting a new standard of care for carotid artery disease,” said David Moeller, senior vice president and president of Peripheral Vascular Health at Medtronic. “Our expanding participation in the growing carotid market underscores our commitment to providing physicians innovative solutions that address unmet health needs.”
Carotid artery disease accounts for about 15% of the 800,000 strokes in the U.S. each year. The Neuroguard system’s closed-cell stent design with FlexRing technology combines flexibility with radial strength, allowing physicians to perform faster, more efficient procedures, Medtronic said. The device is currently only available for investigational use in the U.S.
Clinical data from the 2022 Performance II study showed no major strokes, neurological deaths or stent thromboses at 30 days and one year, even in patients with heavily calcified lesions. Contego Medical is also studying a next-generation version of the technology in the TCAR-Performance III trial.
“The unique 3-in-1 Neuroguard IEP System was designed to respond to this challenge with a 40-micron integrated embolic protection (IEP) filter, which has a smaller pore size to catch the micro-emboli that other protection mechanisms cannot,” Contego Medical Cofounder and CEO Ravish Sachar said. “Partnering with the Medtronic commercial team is expanding our ability to bring this innovation to customers and usher in a new era of safer, smarter carotid artery stenting.”
Medtronic announced its U.S. distribution agreement with Contego Medical in January 2025 as part of an effort to expand its peripheral vascular portfolio.
