Contego Medical Inc., a company dedicated to enhancing patient outcomes and procedural efficiency in treating carotid and peripheral vascular disease, has announced the enrollment of the first patient in the PERFORMANCE III Trial. This trial is a prospective, multicenter study aimed at further assessing the safety and effectiveness of the Neuroguard IEP® Direct System, a carotid stent system designed for direct transcarotid access. It follows the fully enrolled PERFORMANCE II study, which evaluated the same stent placed via percutaneous transfemoral or transradial access. Both PERFORMANCE II and PERFORMANCE III studies are conducted under an Investigational Device Exemption (IDE) through the U.S. Food and Drug Administration (FDA).

Dr. Ravish Sachar, CEO of Contego Medical, expressed the company's commitment to improving patient outcomes and collecting robust clinical data to build upon their IEP (integrated embolic protection) platform technology's success in previous studies. Stacy Enxing Seng, Operating Partner at Lightstone Ventures and Chairman of the Board of Contego Medical, highlighted the company's dedication to advancing patient care by providing top-quality stent, balloon, and filter technology to vascular physicians, regardless of their chosen approach for carotid artery access.

Dr. Sean Lyden, Chairman of the Department of Vascular Surgery at Cleveland Clinic and Co-National Principal Investigator of the PERFORMANCE III Trial, expressed anticipation in studying the Neuroguard IEP Direct System to determine its potential as a new option for patients with carotid artery stenosis.

Both the Neuroguard IEP and Neuroguard IEP Direct Systems utilize Contego Medical's integrated embolic protection (IEP) technology. This platform includes a micro-filter integrated into the delivery catheter, enhancing safety during stent placement and balloon dilation. The micro-filter captures micro-emboli that other protection mechanisms may miss, providing physicians with advanced stroke protection during patient treatment. The Neuroguard IEP Direct System also features a novel single-access-point blood flow reversal system designed for direct transcarotid access. The Neuroguard system is an all-in-one 3-in-1 catheter with the stent, balloon, and micro-filter, reducing catheter exchanges and improving treatment efficiency. It also incorporates the proven FlexRingTM stent technology, combining the best features of open and closed cell stents while leveraging the long-term performance of nitinol.

Dr. Robert Mendes, vascular surgeon at the University of North Carolina Rex Hospital, who treated the first patient in the PERFORMANCE III study, expressed confidence in the Neuroguard IEP Direct system's potential to elevate the standard of care for carotid artery stenosis patients. He praised its unmatched safety, simplicity, and efficiency, describing it as a significant technological advancement in every aspect of the system, from the optimized direct access kit to the blood flow reversal system to the integrated embolic protection (IEP). It represents a leap forward in catheter design, providing comprehensive benefits to patients and healthcare providers alike.

 

Source: prnewswire.com

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