Embolic Protection and neurovascular device expert, InspireMD, Inc. tells us that 12-month follow up data from the PARADIGM-101 will be discussed in two presentations at the Transcatheter Cardiovascular Therapeutics (TCT) 2016 scientific symposium this weekend.
Inspire MD’s CGuard™ EPS is designed to prevent peri-procedural and late embolization by trapping potential emboli against the arterial wall while maintaining excellent perfusion to the external carotid artery and branch vessels.
Previously presented data from the PARADIGM study, which comprised 71 CGuard™ EPS procedures in unselected all-comer patients showed a 100% success rate for the CGuard System and the placement procedure. Additionally, there were no procedure-related complications during CGuard placement or at 30 days post procedure. Similarly, there were or major adverse cardiac or neurological events, as determined by operator-independent neurologist and non-invasive cardiologist evaluation, during CGuard placement or at the 30-day time point.
This weekend’s newly presented data comes from PARADIGM-101, evaluates the use of CGuard™ Embolic Prevention System (EPS) in 101 consecutive patients with carotid artery stenosis (CAS).
PARADIGM is an investigator-initiated Prospective evaluation of All-comer peRcutaneous cArotiD revascularization In symptomatic and increased-risk asymptomatic carotid artery stenosis, using CGuard™ Mesh-covered embolic prevention stent system. The study included patients with symptoms of CAS as well as asymptomatic patients who had an increased risk of stroke.
TCT 2016 is taking place October 29 – November 2 in Washington, D.C. at the Walter E. Washington Convention Center.
Investigator Prof. Piotr Musialek, MD, DPhil, FESC, from the Jagiellonian University Department of Cardiac & Vascular Diseases in Krakow, Poland, will deliver an oral presentation titled “Twelve-month Safety and Efficacy of CGuard™ Micronet-Covered Embolic Prevention Stent System Routine Use to Perform Carotid Revascularization in Symptomatic and Increased-Stroke-Risk Asymptomatic Patients: The Carotid Revascularization PARADIGM All-Comer Prospective Academic Study”. (Presentation Tuesday, November 1, in Room 209, Level 2 of the convention center at 9:32am EDT)
Investigator Adam Mazurek, MD, also from the Jagiellonian University Department of Cardiac & Vascular Diseases John Paul II Hospital will present additional analysis of PARADIGM-101 data in a poster titled “Highly Calcific Carotid Lesions Endovascular Revascularizaton Using a Novel Dual-layer Carotid Stent System CGuard™: Analysis from the PARADIGM Study” (Abstract #796). Saturday, October 29, in Hall B, Lower Level of the convention center from 6:00-8:00pm ET
Source: InspireMD, Inc.