Contego Medical’s Neuroguard IEP System Approved by FDA for Carotid Revascularization

October 15, 2024—Contego Medical announced FDA premarket approval of the company’s Neuroguard IEP system. The three-in-one carotid stenting system combines a high-performance stent, an integrated dilation balloon, and integrated filter.

According to Contego Medical, its integrated embolic protection (IEP) technology features a 40-μm filter integrated on a 6-F 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 three to four times smaller than traditional filters, improving protection against stroke and cognitive impairment.

Additionally, the newest-generation closed-cell stent is highly conformable and shows short- and long-term durability, with no thromboses, no clinically driven target lesion revascularization, and very low restenosis rates at 1 year, stated Contego Medical.

As noted in the press release, clinical studies of the Neuroguard IEP system, including the PERFORMANCE I trial and PERFORMANCE II investigational device exemption trial, have consistently recorded low event rates—zero major strokes, zero neurologic deaths, and zero stent thrombosis at 30 days and 1 year.

William Gray, MD, System Chief of the Division of Cardiovascular Diseases at Main Line Health in Wynnewood, Pennsylvania, is Co-National Principal Investigator of PERFORMANCE II.

“FDA approval confirms the results of the clinical studies,” commented Dr. Gray in Contego Medical’s press release. “The innovative Neuroguard IEP system performs exceptionally well, with the lowest 1-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.”

Ravish Sachar, MD, Contego Medical’s CEO and Founder, added, “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.”

Dr. Sachar further stated, “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.”

Contego Medical noted that in 2023, the Centers for Medicare & Medicaid Services (CMS) issued a national coverage decision significantly expanding coverage for percutaneous transluminal angioplasty of the carotid artery concurrent with stenting performed with FDA-approved carotid stents and embolic protection devices.

The CMS decision and FDA approval of the Neuroguard IEP system position Contego for ongoing growth, stated the company.