Contego Medical's Neuroguard IEP® System is a unique 3-in-1 carotid stenting system that combines a high-performance stent, an integrated dilation balloon, and integrated filter. The system streamlines the carotid stent procedure by reducing the number of steps and makes it safer by capturing emboli that traditional embolic protection systems do not.
RALEIGH, N.C., Oct. 15, 2024 /PRNewswire-PRWeb/ -- Contego Medical, a leader in developing innovative medical devices for cardiovascular procedures, announced the U.S. Food and Drug Administration's (FDA) premarket approval (PMA) of the Neuroguard IEP® System, a unique 3-in-1 carotid stenting system that combines a high-performance stent, an integrated dilation balloon, and integrated filter. The system streamlines the carotid stent procedure by reducing the number of steps and makes it safer by capturing emboli that traditional embolic protection systems do not.
Clinical studies of the Neuroguard IEP System, including the PERFORMANCE I Trial and PERFORMANCE II IDE Trial, have consistently recorded unprecedented low event rates – zero major strokes, zero neurologic deaths, and zero stent thrombosis at 30 days and 1 year.
Dr. William Gray, System Chief of the Division of Cardiovascular Diseases at Main Line Health and Co-National Principal Investigator of the PERFORMANCE II trial, said, "FDA approval confirms the results of the clinical studies. The innovative Neuroguard IEP system performs exceptionally well with the lowest one-year stroke rates ever shown for any type of carotid revascularization, thereby establishing a new standard of care for meaningfully reducing the risk of procedural and long-term stroke among patients with carotid artery disease."
The Neuroguard IEP System utilizes Contego Medical's clinically-proven Integrated Embolic ProtectionTM (IEP) technology, featuring a 40-micron filter integrated on a 6 French delivery catheter. The size of the integrated filter can be adjusted by the operator to custom fit each patient's unique anatomy, and the pores on the filter are 3-4x smaller than those on traditional filters, improving protection against stroke and cognitive impairment. The newest generation closed cell stent is highly conformable and shows remarkable short and long-term durability, with no thromboses, no clinically driven target lesion revascularization, and very low restenosis rates at one year.
"This FDA approval is a huge step forward for Contego and for patient care. The Neuroguard IEP System transforms how we approach patients with carotid artery disease by addressing the specific threats of microembolization while simultaneously reducing procedural steps, ensuring patients receive the highest level of protection throughout the procedure," said Dr. Ravish Sachar, Contego Medical's CEO and Founder. "The ongoing PERFORMANCE III trial is evaluating the Neuroguard IEP system with a next-generation direct transcarotid access and protection system, TCAR-IEP, to demonstrate advanced stroke protection regardless of vascular approach."
In 2023, the Centers for Medicare & Medicaid Services (CMS) issued a national coverage decision significantly expanding coverage for percutaneous transluminal angioplasty (PTA) of the carotid artery concurrent with stenting performed with FDA-approved carotid stents and embolic protection devices. This decision and FDA approval of the Neuroguard IEP System positions Contego for ongoing growth.
For more information on Contego Medical and the Neuroguard IEP System, visit contegomedical.com.
About Contego Medical, Inc.
Contego Medical, Inc., co-founded by Drs. Ravish Sachar and Jay Yadav, 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. More than 3,000 patients have been treated with Contego Medical products to date.
Neuroguard IEP and Integrated Embolic Protection are trademarks or registered trademarks of Contego Medical.
Media Contact
Julie Dye, Contego Medical, 1 5125637261, [email protected], https://contegomedical.com
SOURCE Contego Medical
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