RALEIGH, N.C., Oct. 6, 2023 /PRNewswire/ — Contego Medical Inc., a company dedicated to improving patient outcomes and procedural efficiency in the treatment of carotid and peripheral vascular disease, today announced enrollment of the first patient in the PERFORMANCE III Trial. PERFORMANCE III is a prospective, multicenter trial aimed at further evaluating the safety and effectiveness of the Neuroguard IEP® Direct System, a carotid stent system designed for direct transcarotid access. The study is a follow-on to the fully enrolled PERFORMANCE II study of the Neuroguard IEP System, conducted to evaluate the same stent placed via percutaneous transfemoral or transradial access. Both PERFORMANCE II and PERFORMANCE III studies are being conducted under an Investigational Device Exemption (IDE) through the U.S. Food and Drug Administration (FDA).
“At Contego, we’re driven to improve patient outcomes and will continue to collect robust clinical data to build upon the unprecedented stroke protection results already demonstrated with our IEP (integrated embolic protection) platform technology in the PALADIN and PERFORMANCE I studies,” said Dr. Ravish Sachar, CEO of Contego Medical. Stacy Enxing Seng, Operating Partner at Lightstone Ventures and Chairman of the Board of Contego Medical, added “Contego is committed to advancing care for patients by providing best-in-class stent, balloon, and filter technology so all physicians in the vascular community have the best tools at their disposal, no matter how they choose to access the carotid artery.”
“We look forward to studying the Neuroguard IEP Direct System and determining its potential as a new option for patients with carotid artery stenosis,” said Dr. Sean Lyden, Chairman of the Department of Vascular Surgery at Cleveland Clinic and Co-National Principal Investigator of the PERFORMANCE III Trial.
Both the Neuroguard IEP and Neuroguard IEP Direct Systems leverage Contego Medical’s integrated embolic protection (IEP) technology, a unique platform with a micro-filter integrated on the delivery catheter, designed to deliver added safety where it matters most – during stent placement and balloon dilation. The micro-filter captures the micro-emboli other protection mechanisms don’t, giving physicians the procedural confidence that comes with advanced stroke protection in the treatment of their patients. The Neuroguard IEP Direct System also includes a novel single-access-point blood flow reversal system specifically designed for direct transcarotid access. The Neuroguard system is a 3-in-1 catheter with the stent, balloon, and micro-filter all in one device, minimizing catheter exchanges and improving treatment efficiency. Neuroguard also utilizes proven FlexRingTM stent technology, providing the best properties of both open and closed cell stents while leveraging the proven long-term material performance of nitinol.
“I have no doubt the Neuroguard IEP Direct system will elevate the standard of care for carotid artery stenosis patients,” said Dr. Robert Mendes, vascular surgeon at the University of North Carolina Rex Hospital, who treated the first patient in the PERFORMANCE III study. “Its safety is unmatched, and it is simple and efficient to operate. This is an across-the-board advancement in technology in every aspect of the system, from the optimized direct access kit to the blood flow reversal system to the added integrated embolic protection (IEP). It’s a 3-in-1 leap forward in catheter design.”
About Contego Medical, Inc.
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 in the treatment of carotid and peripheral vascular disease. Contego Medical has FDA clearance for the Paladin® IEP carotid PTA balloon and filter system, the Vanguard IEP® peripheral balloon angioplasty and filter system, and the Excipio SV and LV Thrombectomy Devices. The Neuroguard IEP and Neuroguard IEP Direct Systems are currently limited by Federal US law to investigational use only in the PERFORMANCE II study (NCT04201132) and the PERFORMANCE III study (NCT05845710) respectively. The Paladin IEP System, Vanguard IEP System, and the Neuroguard IEP System have also received CE mark approval.
The Paladin IEP, Neuroguard IEP, and Neuroguard IEP Direct carotid artery revascularization solutions and the Vanguard IEP peripheral revascularization solution all leverage the company’s proprietary integrated embolic protection technology, designed to safeguard against embolization and improve efficiency. The peripheral vascular Excipio thrombectomy devices are designed for immediate, controlled, single-session results with maximum removal of soft, organized, and wall adherent thrombus without thrombolytics. More than 3,000 patients have been treated with Contego Medical products to-date.
Paladin, Neuroguard IEP, Vanguard IEP, Excipio, Integrated Embolic Protection, and FlexRing are trademarks or registered trademarks of Contego Medical.
SOURCE Contego Medical, LLC
Originally published at https://www.prnewswire.com/news-releases/contego-medical-announces-start-of-enrollment-in-performance-iii-direct-transcarotid-access-stenting-trial-301949659.html
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