Contego Medical has announced the presentation of late-breaking clinical results from the PERFORMANCE II carotid stent trial at the annual Vascular Interventional Advances (VIVA) meeting (30 October–2 November 2023, Las Vegas, USA). PERFORMANCE II is a prospective, multicentre study evaluating the safety and effectiveness of the Neuroguard integrated embolic protection (IEP) system in 305 patients at 40 clinical sites.
“The one-year event rates in the PERFORMANCE II study are the lowest ever reported in any adequately powered, prospective, multicentre study of any type of carotid artery revascularisation, regardless of patient risk,” said William Gray (Main Line Health, Philadelphia, USA), co-national principal investigator of the PERFORMANCE II trial. “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, the reported 30-day stroke rate was 1.31% in the 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, according to a Contego press release. At one-year follow-up (all stroke within 30 days, and ipsilateral stroke between day 31 and 12 months), the reported stroke rate was 1.68% in the intention-to-treat analysis and 1.35% in a per-protocol analysis. No major strokes or neurological deaths occurred in the study.
The release details that the Neuroguard IEP system leverages Contego’s clinically proven IEP technology—a unique platform with a micro-filter integrated on the delivery catheter, which is designed to deliver added safety during stent placement and balloon dilation. The micro-filter with 40µm pores captures the micro-emboli that other protection mechanisms do not, the release adds, giving physicians the procedural confidence that comes with advanced stroke protection in the treatment of their patients. The Neuroguard closed-cell stent also utilises FlexRing technology, providing optimised radial strength and flexibility while leveraging nitinol’s proven long-term material performance, Contego further claims.
“The recent change in coverage by the Centers for Medicare & Medicaid Services (CMS) increases patient access to carotid artery treatment,” said Contego chief executive officer Ravish Sachar. “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.
“Our mission is to provide a new class of products which improve patient outcomes and procedural efficiency,” said Stacy Enxing Seng, operating partner at Lightstone Ventures and chairman of the board at Contego. “The IEP platform, as demonstrated in the PALADIN, PERFORMANCE I and PERFORMANCE II studies, meaningfully advances stroke protection for patients. For physicians, it offers reduced catheter exchanges and improved efficiency with a three-in-one design, combining the Neuroguard stent, balloon and filter all in one device.”