Medtronic Launches Full Distribution of New 3-in-1 Carotid Stent
Dave Fornell | October 10, 2025 | Cardiovascular Business | Interventional Cardiology
Medtronic has expanded its carotid stent portfolio by announcing the full distribution of its Neuroguard IEP System. The 3-in-1 device includes a stent, dilation balloon and embolic protection filter, simplifying carotid stenting procedures.
The launch follows the January news that Medtronic had signed an exclusive U.S. distribution agreement with Contego Medical, which manufactures the Neuroguard IEP System. Medtronic has held a minority investment in the North Carolina-based company since 2020. This agreement includes an increased investment and gives Medtronic the option to acquire Contego Medical in full at a later date.
“With this launch, we are setting a new standard of care for carotid artery disease,” said David Moeller, senior vice president and president of Medtronic’s peripheral vascular health division, in a statement. “Our expanding participation in the growing carotid market underscores our commitment to providing physicians innovative solutions that address unmet health needs.”
This 3-in-1 device comes at a time in interventional cardiology and peripheral vascular medicine where there are growing procedure volumes for carotid stenting. This stems from an October 2023 change in the Medicare carotid artery stenting national coverage determination (NCD) that increased the number of patients eligible for reimbursement. Experts predicted this would result in rising procedure volumes.
Medtronic emphasized that carotid artery disease is a significant cause of stroke, causing about 15% of the 800,000 strokes in the U.S. annually. Also, emboli released during carotid stenting can result in a stroke, making the use of an embolic protection filter critical.
“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,” Ravish Sachar, MD, founder and CEO, Contego Medical, said in the same statement. He is also physician-in-chief of the North Carolina Heart and Vascular Hospital. “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.”
The device performed well in the PERFORMANCE II study presented in 2022, which demonstrated at 30 days and one year zero major strokes, neurological deaths, stent thromboses or clinically driven target lesion revascularization, despite 34.5% of lesions treated being severely calcified.
Contego Medical said its is currently evaluating the Neuroguard IEP System with a next-generation direct transcarotid access and protection system, TCAR-IEP, in the PERFORMANCE III trial. If data from that trial is positive, the next-generation Neuroguard IEP Direct system could further streamline procedures.
Medtronic also offers the more conventional Protégé RX self-expanding carotid stent as part of its carotid portfolio. It comes in both straight or tapered models, enabling a custom fit in the common carotid, internal carotid arteries and carotid bifurcation.
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