RALEIGH, NC, November 14, 2022 /PRNewswire/ — Contego Medical, Inc. announced that enrollment of the PERFORMANCE II clinical trial has been completed. PERFORMANCE II is designed to evaluate the safety and effectiveness of the Neuroguard IEP® 3-in-1 Carotid Stent and Post-Dilation Balloon System with Integrated Embolic Protection. The Neuroguard IEP System is designed to treat clinically significant carotid artery stenosis while improving procedural safety through the integration of the stent, balloon and an embolic filter all in a single device.
“The Neuroguard IEP System combines a truly innovative stent design with a multi-function delivery platform for advanced protection from stroke, while reducing the number of catheter exchanges needed to complete the procedure. Additionally, it has outstanding conformability for a closed cell stent, allowing the advantages of this stent system in a wide variety of carotid anatomies,” said Christopher Metzger, MD at Holston Valley Medical Center in Kingsport, TN and lead enroller in the trial.
PERFORMANCE II is a prospective, multicenter, single-arm, open label study for the treatment of carotid artery stenosis in subjects at high risk for carotid endarterectomy. The trial enrolled 305 patients at 32 sites in the U.S. and Europe. Principal Investigators of the study are William Gray, MD (Main Line Health, Wynnewood, Pennsylvania) and Ralf Langhoff, MD (Sankt Gertrauden Hospital, Berlin, Germany). Results of the study will be used to support an FDA Pre-Market Approval application.
According to William Gray, MD, “The Neuroguard IEP technology may offer significant benefits to patients suffering from severe carotid stenosis, specifically with the potential to lower the embolic burden and overall stroke rates.”
“This is a well-executed clinical trial that is designed to demonstrate that the Neuroguard IEP System is both safe and effective,” said Stacy Enxing Seng, Venture Partner at Lightstone Ventures and Chairman of the Board of Contego Medical. “We believe that once available, the Neuroguard IEP System has the potential to be the standard of care for the treatment of extracranial carotid disease.”
The Neuroguard IEP System is designed to safeguard against stroke by integrating a novel, next-generation stent, a pre-positioned post-dilation balloon, and a microembolic filter. The stent has a closed-cell design with FlexRingTM technology for optimal balance of plaque coverage, radial strength, and flexibility. The integrated 40μm filter is designed to capture more micro-embolic debris than traditional filters.
Ravish Sachar, MD, CEO and Founder of Contego Medical commented, “Completing enrollment in PERFORMANCE II is a critical milestone on our path to bring this state-of-the-art technology to patients with carotid artery disease. We are extremely grateful to the physicians and patients who participated in this important study.”
About Contego Medical
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 during revascularization treatment for carotid and peripheral vascular disease. Contego has FDA clearance for the PaladinÒ Carotid PTA Balloon System with Integrated Embolic Protection (IEP), the Vanguard IEPÒ Peripheral Balloon Angioplasty System with Integrated Embolic Protection, and the Excipio SV Thrombectomy Device. The Neuroguard IEP® 3-in-1 Carotid Stent and Post-Dilation Balloon System with Integrated Embolic Protection is currently limited by US federal law to investigational use in the PERFORMANCE-II study. The Paladin System, Vanguard IEP System, and the Neuroguard IEP system have also received CE mark.
Full details on the PERFORMANCE II study can be found on Clinicaltrials.gov. NCT04201132
Neuroguard IEP and the Contego Medical logo are registered trademarks of Contego Medical, Inc. The Neuroguard System is covered by U.S. patents 9,968,472 & 10,932,929. Additional US and Foreign patents pending.
SOURCE Contego Medical, Inc.
Contact: David Stern, President & COO +1-404-435-8137
