Contego Medical announced late-breaking clinical results from the PERFORMANCE III carotid stent study. At 30 days, the 146 patients in the study had no strokes or myocardial infarctions, and there were no neurological deaths. These are the lowest ever reported results in a prospective, multicenter carotid artery revascularization study.
RALEIGH, N.C., Nov. 4, 2025 /PRNewswire-PRWeb/ -- Contego Medical Inc., a company dedicated to improving patient outcomes and procedural efficiency in the treatment of carotid and peripheral vascular disease, today announced late-breaking clinical results from the PERFORMANCE III carotid stent study. The prospective, multicenter study evaluated the safety and effectiveness of the Neuroguard IEP® System, 70cm carotid stent, and the Neuroguard IEP® Embolic Protection System for direct transcarotid artery revascularization (TCAR-IEP) in 146 subjects across 26 clinical sites. The Neuroguard IEP® Embolic Protection System includes both a direct access kit and a blood flow reversal system.
Results were presented at the annual VIVA (Vascular InterVentional Advances) multidisciplinary vascular conference, with additional data to be shared at the upcoming VEITH Symposium.
"The 30-day event rates in the PERFORMANCE III study are the lowest reported in a prospective, multicenter carotid artery revascularization study," said Dr. Sean Lyden, Chairman of the Department of Vascular Surgery at Cleveland Clinic and Co-National Principal Investigator of the PERFORMANCE III study.
In the PERFORMANCE III study, the 30-day stroke rate was 0% per the intention-to-treat analysis, with 0 myocardial infarctions, 0 cranial nerve injuries, 0 neurological deaths, and 0 stent thromboses reported. The primary endpoint of major adverse events through 30 days was 0.69% (intention-to-treat) and 0% (per-protocol), significantly lower than the pre-defined study performance goal.
The Neuroguard IEP System, 70cm for direct transcarotid revascularization leverages Contego Medical's proprietary integrated embolic protection (IEP) technology — a 40-micron distal filter integrated on the delivery catheter for added safety during the highest-risk phases of stenting. This clinically proven platform technology has demonstrated unprecedented outcomes in 4 prospective multi-center studies- Paladin IEP, PERFORMANCE I, PERFORMANCE II, and PERFORMANCE III. The Neuroguard IEP stent was previously studied for transfemoral and transradial carotid stenting in the PERFORMANCE II study. The Neuroguard IEP System, 140cm received FDA PMA approval in October 2024.*
For direct transcarotid access, Neuroguard provides dual-neuroprotection through both flow reversal and integrated embolic protection (IEP), establishing a new approach category- TCAR-IEP. The 3-in-1 Neuroguard IEP system combines the stent, balloon, and integrated filter all-in-one device, minimizing catheter exchanges and enhancing procedural efficiency. The Neuroguard stent utilizes FlexRingTM technology, offering optimized radial strength and flexibility. The Neuroguard direct access sheath, purpose-built for transcarotid access, features a pre-formed curve and enhanced flexibility.
"We are committed to advancing the next generation of clinically proven carotid technology for patients with our best-in-class stent, balloon, embolic protection, and access systems," said Dr. Ravish Sachar, CEO of Contego Medical. "Our mission is to ensure vascular physicians have the best and most efficient tools at their disposal, no matter how they choose to access the carotid artery."
About Contego Medical, Inc.
Contego Medical, Inc. is the leader in developing state-of-the-art solutions that transform complex cases into simplified procedures. The company's portfolio of integrated, multi-functional products is designed to improve patient outcomes and procedural efficiency in the treatment of carotid and peripheral vascular disease.
The patented Neuroguard IEP System, 70cm and the Neuroguard IEP Embolic Protection System for direct transcarotid access, are currently limited by Federal US law to investigational use only in the PERFORMANCE III study (NCT05845710).
Neuroguard IEP, Integrated Embolic Protection, and FlexRing are trademarks or registered trademarks of Contego Medical, Inc.
* Medtronic is the sole distributor of the Neuroguard IEP System, 140cm for transfemoral and transradial carotid stenting.
Media Contact
Julie Dye, Contego Medical, 1 5125637261, [email protected], https://contegomedical.com/
SOURCE Contego Medical
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