Medtronic Commences Full Distribution of Contego Neuroguard IEP for Carotid Stenting in the United States

October 8, 2025—Medtronic announced full distribution in the United States of Contego Medical’s Neuroguard integrated embolic protection (IEP) system after conducting a limited market rollout. The three-in-one carotid stenting system combines a stent, postdilation balloon, and 40-µm integrated embolic protection filter, noted Medtronic.

FDA premarket approval of the Neuroguard IEP system was announced by Contego Medical in October 2024.

According to Medtronic, the Neuroguard platform incorporates a closed-cell stent with FlexRing technology. The design is intended to combine the radial strength of closed-cell stents with the flexibility of open-cell configurations.

Medtronic stated that the full launch of Neuroguard IEP marks the next phase of the company’s exclusive United States distribution agreement with Contego Medical, which was announced in January 2025.

The agreement covers distribution rights of Contego’s entire portfolio of commercially available products in the United States through Medtronic’s Peripheral Vascular and Neurovascular divisions, noted the company.

The company reported that clinical data from the PERFORMANCE II study demonstrated zero major strokes, neurological deaths, stent thromboses, or clinically driven target lesion revascularizations at 30 days and 1 year, despite 34.5% of lesions being severely calcified. The 2-year findings from PERFORMANCE II were presented by William A. Gray, MD, at VIVA24, the 22nd annual Vascular InterVentional Advances symposium in November 2024.

Medtronic also advised that Contego Medical is studying the Neuroguard IEP system with a direct transcarotid access and protection system in the PERFORMANCE III trial, which commenced enrollment in 2024. Neuroguard IEP Direct is investigational and not commercially available in the United States.