FDA Approves Contego’s Neuroguard IEP Direct System for TCAR-IEP

November 11, 2026—Contego Medical Inc. announced FDA premarket approval (PMA) of the Neuroguard IEP Direct system and 510(k) clearance of the Neuroguard IEP embolic protection system.

According to the company, these systems together provide dual neuroprotection through both flow reversal and an integrated embolic protection (IEP) filter via direct transcarotid access. The procedure establishes a new approach category to carotid revascularization: TCAR-IEP.

Contego stated that the PERFORMANCE III pivotal study of TCAR-IEP reported 30-day outcomes with a 0% stroke rate in the intention-to-treat population and no myocardial infarctions, cranial nerve injuries, neurological deaths, or stent thromboses. The primary endpoint, the 30-day rate of major adverse events, was 0.69% in the intention-to-treat population and 0% in the per-protocol population.

Sean Lyden, Chairman of the Department of Vascular Surgery at Cleveland Clinic in Cleveland, Ohio, serves as Co-National Principal Investigator of the PERFORMANCE III investigational device exemption study.

“Although transcarotid artery revascularization with flow reversal alone has demonstrated low stroke rates, transcranial Doppler studies have shown that flow to the brain is not always reversed, thereby allowing microemboli to still reach the brain in some patients,” commented Dr. Lyden in Contego’s press release. “Given the uncertainty in complete flow reversal, this system combines flow reversal with an integrated filter to provide additional protection during the highest-risk phases of stenting and postdilation.”

The previous PERFORMANCE I and PERFORMANCE II studies evaluated the Neuroguard IEP 3-in-1 system for transfemoral and transradial carotid stenting. The Neuroguard IEP 3-in-1 system received FDA approval in October 2024 and is commercially distributed by Medtronic.