Medtronic Launches Full Distribution of Integrated Embolic Protection System

Oct. 7, 2025 — Medtronic has announced the full distribution of the Neuroguard IEP System (Neuroguard) after a successful limited market distribution. This milestone follows the announcement earlier this year of its exclusive U.S. distribution agreement with Raleigh, North Carolina-based Contego Medical.

Neuroguard is the first carotid artery stent to offer a unique 3-in-1 technology that combines a high-performance stent⁶, an integrated dilation balloon, and integrated filter. Purposefully-built for the carotid artery,⁶ the closed-cell stent design with FlexRing technology provides the benefits of both open and closed cell stents with flexibility and radial strength.^7-8, ‡ This integrated system offers physicians a faster, more streamlined, and efficient procedure. ^{6, 9-10 §◊¶}

"With this launch, we are setting a new standard of care for carotid artery disease," said David Moeller, SVP and president, Peripheral Vascular Health, which is part of the Cardiovascular Portfolio 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 is a significant cause of stroke, causing approximately 15% of the 800,000 strokes in the U.S. each year.^11-12 Yet, paradoxically, the biggest risk in carotid artery stenting has been the risk of stroke, primarily from micro-embolic debris released during balloon dilation.¹⁴

"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,"^15-18# said Ravish Sachar, MD, founder and CEO, Contego Medical. "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."

Neuroguard is supported by exceptional clinical data demonstrating the safety and effectiveness of the system. The PERFORMANCE II study (2022) demonstrated zero major strokes, zero neurological deaths, zero stent thromboses, and zero clinically driven target lesion revascularization despite 34.5% severely calcified lesions at 30 days and one year.^19 ∆∞

Additionally, Contego Medical is currently evaluating the Neuroguard IEP System with a next-generation direct transcarotid access and protection system, TCAR-IEP, to demonstrate safety and effectiveness in the PERFORMANCE III trial. The Neuroguard IEP Direct system is currently limited by Federal law to investigational use only and is not commercially available in the U.S.

Medtronic first announced the exclusive U.S. distribution agreement with Contego Medical in January 2025. Under the agreement, Medtronic is the sole U.S. distributor for Contego's portfolio of commercially available products through its Peripheral Vascular and Neurovascular commercial teams.

Neuroguard IEP and FlexRing are third party trademarks of Contego Medical.

References

† Second filter provides extra embolic protection during post-dilitation
^‡ Bench test data may not be indicative of clinical performance
§ The integrated stent with post-dilation balloon eliminates the catheter exchanges associated with using two separate devices.
◊ Bench test data may not be indicative of clinical performance
¶ Median procedure times included Neuroguard IEP (n=305): 47 minutes, Traditional CAS (n=14,595): 61 minutes, Surgical CEA (n=82,737): 110 minutes
# Pore sizes of various embolic protection devices: Neuroguard™* 40μm, ANGIOGUARD™* RX 100μm, Emboshield NAV6™* 120μm.
∆ Clinically-driven target lesion revascularization as defined by >80% narrowing at the original treatment site by the angiographic core lab.
∞ 1.3% 30-day all stroke, 1.8% 30-day all stroke plus 12-month ipsilateral stroke, 2.8% primary endpoint (composite of 30-day death/MI/stroke and 1-year ipsilateral stroke rates) through 12 months

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