Results of the PERFORMANCE II Trial were presented by William Gray, MD, System Chief, Division of Cardiovascular Diseases, Main Line Health, and Co-National Principal Investigator, during the annual VIVA (Vascular InterVentional Advances), VIVA 23, held this week in Las Vegas, NV. Image courtesy: Contego Medical, Inc.
November 2, 2023 — Contego Medical Inc. announced the presentation of late-breaking clinical results from the PERFORMANCE II carotid stent trial at the annual Vascular InterVentional Advances, VIVA 23, being held by the Viva Foundation Oct. 30-Nov. 2 in Las Vegas, NV. The PERFORMANCE II is a prospective, multicenter study evaluating the safety and effectiveness of the Neuroguard IEP System in 305 patients at 40 clinical sites.
“The 1-year event rates in the PERFORMANCE II Study are the lowest ever reported in any adequately powered, prospective, multicenter study of any type of carotid artery revascularization, regardless of patient risk,” said William Gray, MD, System Chief, Division of Cardiovascular Diseases, Main Line Health, and Co-National Principal Investigator of the PERFORMANCE II Trial. He added, “These results can elevate the standard of care for patients with severe carotid artery disease who are deemed appropriate for intervention by delivering demonstrated best-in-class stroke protection.”
In the PERFORMANCE II study, according to a statement detailing the trial, the reported 30-day stroke rate is 1.31% in an intention-to-treat analysis and 0.98% in a per-protocol analysis, with no major strokes or contralateral strokes, and all patients returning to baseline neurologically within 30 days. At 1-year follow-up (all stroke within 30 days and ipsilateral stroke between day 31 and 12 months), the reported stroke rate is 1.68% in an intention-to-treat analysis and 1.35% in a per-protocol analysis. No major strokes or neurological deaths occurred in the study.
The Neuroguard IEP System leverages Contego Medical’s clinically proven integrated embolic protection (IEP) technology, a unique platform with a micro-filter integrated on the delivery catheter, noted the company statement. It further added that it is designed to deliver added safety where it matters most – during stent placement and balloon dilation. The micro-filter with 40µm pores 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 closed cell stent utilizes FlexRingTM technology, providing optimized radial strength and flexibility while leveraging nitinol’s proven long-term material performance.
“The recent change in coverage by the Centers for Medicare & Medicaid Services (CMS) increases patient access to carotid artery treatment,” said Ravish Sachar, MD, CEO of Contego Medical. Sachar added, “We are committed to providing the most advanced and clinically proven technology to all patients and their physicians in the vascular community.”
In addition to the PERFORMANCE II Study, in which Neuroguard was placed via transfemoral or transradial access, the PERFORMANCE III Study is currently enrolling patients to evaluate the same stent placed via direct transcarotid access.
“The IEP platform, as demonstrated in the PALADIN, PERFORMANCE I and PERFORMANCE II studies, meaningfully advances stroke protection for patients,” said Stacy Enxing Seng, Operating Partner at Lightstone Ventures and Chairman of the Board, Contego Medical, adding, “For physicians, it offers reduced catheter exchanges and improved efficiency with a 3-in-1 design, combining the Neuroguard stent, balloon, and filter all in one device.”
Contego Medical, Inc. develops 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.
The patented Neuroguard IEP System is currently limited by Federal US law to investigational use only in the PERFORMANCE II study (NCT04201132). The Neuroguard IEP Direct System is currently limited by Federal US law to investigational use only in the PERFORMANCE III study (NCT05845710). More than 3,000 patients have been treated with Contego Medical products to-date.
More information: www.contegomedical.com
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June 08, 2023 
