Expanded two-year follow-up results from the PARADIGM clinical study using CGuard EPS

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Cguard EPS

Piotr Musiałek, from the Department of Cardiac and Vascular Diseases, John Paul II Hospital, Kraków, Poland, presented the expanded 24-month follow-up results from the PARADIGM-Extend Clinical Study utilising CGuard EPS (InspireMD) at EuroPCR 2018 (22–25 May, Paris, France).

PARADIGM-Extend is the continuation of PARADIGM, an investigator-led clinical study evaluating the use of CGuard EPS in patients with symptomatic or asymptomatic carotid artery stenosis with increased stroke risk. The latest results include 251 patients, which is more than double the patient population of 101, which was previously reported in December 2017. Overall cumulative data showed no major strokes in the peri-procedural or post-procedural period up to 30 days (0%). There was one minor peri-procedural stroke (0.4%), and only one death (non-device related) at 30 days (0.4%). These results are consistent with earlier reported data in the first patient cohort. Importantly, there were no stroke or stroke-related deaths between 12 and 24 months.

Musialek commented, “The 24-month clinical and duplex ultrasound evidence is consistent with the unprecedented, sustained safety and cerebral embolism prevention efficacy of CGuard EPS in both symptomatic and asymptomatic patients with carotid stenosis.”

“We feel privileged to have had Professor Musialek, one of the leading interventional cardiologists in Europe, present his expanded results of the PARADIGM study at EuroPCR 2018,” said James Barry, chief executive officer of InspireMD. “Professor Musialek’s PARADIGM-Extend trial continues to demonstrate consistent and strong clinical evidence of durable protection against potential stroke that can result from post procedural embolization. In addition, the duplex ultrasound data confirms normal vessel healing with the CGuard EPS device and with no indication of any long term in-stent restenosis. These results include a significant proportion of challenging patients that would have otherwise been sent to surgery (carotid endarterectomy).  Furthermore, these results are consistent with other CGuard EPS clinical trials including: CARENET, IRON-GUARD, WISSGOTT Study and CASANA Study. This excellent data continues to build on the extensive body of evidence supporting the clinical advantages of CGuard EPS in preventing stroke that can result from high grade carotid stenosis.”

EuroPCR is the official annual meeting of the European Association of Percutaneous Cardiovascular Interventions (EAPCI) and the world-leading course in interventional cardiovascular medicine. Bringing together over 12,000 clinicians and industry executives each year, EuroPCR is a global forum for sharing within and between all interventional communities.

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