Three-Year Neuroguard IEP PERFORMANCE II Data Presented

March 13, 2026—Three-year outcomes from the PERFORMANCE II trial studying the Neuroguard Integrated Embolic Protection (IEP) 3-in-1 Carotid Stent System were presented by William A. Gray, MD, at the International Symposium on Endovascular Therapy (ISET).

Key among the presented findings were low stent-related stroke events, including no major strokes through 3 years of follow-up; there were two minor strokes between 1 and 3 years and seven total minor strokes through 3 years. No early or late stent thromboses were observed, and there were no incidences of neurological death. The rates of target lesion revascularization (TLR) and clinically driven TLR (CD-TLR) were low at 3% (7/232) and 0.4% (1/232), respectively.

In-stent restenosis (ISR) was observed in 5.2% (12/232). Eight of these were in the first 360 days, while two were between days 361 and 720, and a further two were between days 721 and 1080.

PERFORMANCE II enrolled 305 patients in a prospective multicenter single-arm study. Enrolled patients had to be symptomatic with ≥ 50% stenosis or asymptomatic with ≥ 80% stenosis, and at least one anatomic or medical comorbidity considered to be high risk for adverse events after carotid endarterectomy. The primary endpoint was 30-day rate of periprocedural death, stroke, or myocardial infarction within 30 days of the index procedure plus ipsilateral stroke within 12 months. Secondary endpoints included procedural and technical success; percentage of CD-TLR within 12 months; ISR through 12, 24, and 36 months; major and minor stroke through 30 days; and neurological death through 12 months.

Key results at 30 days included a major adverse event rate of 2.3% (7/305), comprising one death, four minor strokes, and two myocardial infarctions.

Ralf Langhoff, MD, from Sankt-Gertrauden-Krankenhaus in Berlin, Germany, and Dr. Gray, from Main Line Health in Wynnewood, Pennsylvania, served as Principal Investigators. Findings were adjudicated by an independent data safety monitoring board and clinical events committees.

“These outcomes demonstrate excellent durability of the initial safety results,” said Dr. Gray in comments to Endovascular Today. “What makes these findings particularly important is that they represent long-term device-specific outcomes. Most carotid stent studies report results across multiple devices, and most device-specific trials do not have 3-year data. Here, we have long-term data tied to a single platform in a high-risk population. When compared with broader low-risk datasets like CREST-2 or ACST-2, which include multiple stent types, the outcomes are as good as—or even better than—those benchmarks. Having robust 3-year results from a single device provides a very valuable level of clarity for clinicians.”

Developed by Contego Medical, the Neuroguard IEP is distributed by Medtronic. The platform gained FDA approval in October 2024.

“The PERFORMANCE II 3-year outcomes first presented at ISET fill a much-needed gap in long-term clinical evidence for next-generation carotid artery stents,” added Dave Moeller, SVP and President, Medtronic Peripheral Vascular Health. “With zero major strokes, zero stent thromboses, and low CD-TLR rates through 3 years, this data adds to the body of evidence demonstrating the safety, effectiveness—and now durability—of the Neuroguard IEP system.”