PERFORMANCE III 30-Day Outcomes Reported for Contego Neuroguard TCAR-IEP System

November 3, 2025—Contego Medical announced 30-day outcomes from the PERFORMANCE III study evaluating the Neuroguard IEP system for direct transcarotid artery revascularization (TCAR-IEP).

Among 146 patients treated at 26 sites, investigators reported no stroke, myocardial infarction, neurological death, cranial nerve injury, or stent thrombosis, according to the company’s press release.

Results were presented by Sean P. Lyden, MD, during a late-breaking clinical trials session at VIVA25, with additional data to be shared at the upcoming VEITHsymposium.

“The 30-day event rates in the PERFORMANCE III study are the lowest reported in a prospective, multicenter carotid artery revascularization study,” commented Dr. Lyden, Chairman of the Department of Vascular Surgery at Cleveland Clinic and Co-National Principal Investigator of the study.

The prospective, multicenter PERFORMANCE III trial assessed the safety and efficacy of Contego Medical’s Neuroguard IEP system for transcarotid access using integrated embolic protection (IEP). The primary endpoint—major adverse events through 30 days—occurred in 0.69% of patients in the intention-to-treat analysis and 0% in the per-protocol cohort, both below the prespecified performance goal.

According to the company, the Neuroguard IEP system for TCAR integrates a closed-cell nitinol stent, a semicompliant postdilation balloon, and a 40-μm embolic filter into a single device on a 70-cm delivery system, used in conjunction with an embolic protection system providing flow reversal. These features together deliver dual neuroprotection while reducing catheter exchanges and enhancing procedural efficiency.

Contego Medical previously evaluated the Neuroguard IEP system in the PERFORMANCE II study; the device received FDA premarket approval in October 2024 for transfemoral and transradial use. The 70-cm TCAR-IEP iteration remains investigational under the PERFORMANCE III protocol.

In January 2025, it was announced that Medtronic would be the sole United States distributor for Contego’s portfolio of commercially available products, including the 140-cm Neuroguard IEP system for transfemoral and transradial carotid stenting.