Contego Medical received FDA premarket approval for the Neuroguard IEP Direct System and 510(k) clearance for Neuroguard IEP Embolic Protection System to treat narrowed carotid arteries. The approvals give clinicians a new option for a procedure that previously carried a risk of stroke after microemboli reached the brain. In The PERFORMANCE III pivotal study, there was a 0% stroke rate reported through 30 days.
RALEIGH, N.C., Nov. 10, 2026 /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 the U.S. Food and Drug Administration's (FDA) premarket approval (PMA) of the Neuroguard IEP® Direct System and 510(k) clearance of the Neuroguard IEP® Embolic Protection System (EPS). Together, these systems provide dual-neuroprotection through both flow reversal and an integrated embolic protection (IEP) filter via direct transcarotid access, establishing a new approach category to carotid revascularization- TCAR-IEP.
"Although TCAR 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," said Dr. Sean Lyden, Chairman of the Department of Vascular Surgery at Cleveland Clinic and Co-National Principal Investigator of the PERFORMANCE III IDE study. "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 post-dilation."
The PERFORMANCE III pivotal study of TCAR-IEP reported unprecedented 30-day outcomes with a 0% stroke rate in the intention-to-treat population and 0 myocardial infarctions, 0 cranial nerve injuries, 0 neurological deaths, and 0 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.
The Neuroguard IEP 3-in-1 stent delivery system integrates the stent, balloon, and 40-micron distal filter all in one device, reducing catheter exchanges and enhancing procedural efficiency. Its closed-cell stent incorporates FlexRingTM technology, designed to optimize radial strength and flexibility. The Neuroguard IEP EPS combines a purpose-built direct access sheath with a flexible, pre-formed curve and a gravity-assisted flow reversal system, enabling streamlined transcarotid access without the need for venous access.
The Neuroguard IEP 3-in-1 system was previously studied for transfemoral and transradial carotid stenting in the PERFORMANCE I and PERFORMANCE II studies. It received FDA PMA approval in October 2024 and is commercially distributed by Medtronic.
"This approval marks the culmination of more than a decade of development and four prospective, multi-center studies to achieve our mission to deliver unprecedented clinical results in a simplified and efficient carotid revascularization procedure," said Dr. Ravish Sachar, Founder and CEO of Contego Medical. "We can now offer all vascular physicians and their patients access to our advanced technology, regardless of whether they choose a transfemoral, transradial, or transcarotid approach. We are grateful to the many physicians, participating clinical sites, dedicated employees, and investors—including Hatteras Venture Partners, U.S. Venture Partners, Lightstone Ventures, and Amzak Health—who supported us throughout this journey."
About Contego Medical, Inc.
Contego Medical, Inc., founded by Drs. Ravish Sachar and Jay Yadav, is a leader in developing advanced vascular technologies 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.
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 for transfemoral and transradial carotid stenting.
Media Contact
Julie Dye For Contego Medical, Marketing Dx, 1 5125637261, [email protected], https://marketingdx.com/
SOURCE Contego Medical Inc
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