InspireMD’s CGuard Embolic Prevention System Data Presented at LINC

June 9, 2022—InspireMD, Inc. announced highlights from presentations and a live case featuring the company’s CGuard embolic prevention stent (EPS) system at LINC 2022, the Leipzig Interventional Course held June 6-9 in Leipzig, Germany.

At LINC, Savr Bugorov, MD, presented 12-month secondary endpoint data from the randomized controlled trial of the company’s MicroNet-covered CGuard stent system versus a first-generation open-cell carotid stent (Acculink, Abbott). For CGuard versus Acculink at 1 year, the cumulative incidence of death, stroke, or myocardial infarction (MI)—DSMI—was 2% (n = 1) versus 10% (n = 5); the incidence of restenosis or vessel occlusion was 0% (n = 0) versus 8% (n = 4).

Piotr Musialek, MD, presented new data from PARADIGM-500, the largest all-comers single-center registry of neuroprotected CGuard carotid artery stenting procedures. PARADIGM-500 includes 500 patients enrolled with 533 procedures performed.

In his presentation, “MicroNet-Covered Stent in Stroke Prevention and Treatment: New Evidence,” Dr.Musialek reported the following:

• Within 48 hours of the procedure, the periprocedural DSMI event rate was 0.56% (n = 3), including two minor strokes and one MI.
• At 30 days, there were no strokes but two deaths, resulting 0.94% (n = 5) cumulative 30-day DSMI rate.
• At 12 months, there were no major ipsilateral strokes and a rate of 0.41% (n = 2) of stent restenosis/target lesion revascularization on duplex ultrasound follow-up.

Dr. Musialek concluded, “Competent carotid artery stenting, with a tailored use of the access route (transfemoral, transradial, transcarotid), tailored use of a proximal/distal embolic protection device, and a 100% embolic prevention stent use shows unprecedented safety and efficacy in asymptomatic and increased-stroke-risk asymptomatic patients.”

In a presentation titled, “Stent Properties and Vessel Adaptability: Could These Factors Influence Procedural Outcomes?,” Matteo Stefanini, MD, reported that CGuard was the only stent that maintained the original vessel morphology while the compared stents, Wallstent (Boston Scientific) and Roadsaver (Terumo Europe), significantly altered the vessel shapes. Dr. Stefanini, the investigator, concluded that CGuard optimizes conformability compared to the other stents.

Finally, interventional angiologists Andrej Schmidt, MD, and Andreas Fischer, MD, conducted a live case transmission from the Heart Center Leipzig. The patient, age 62 years, was an asymptomatic male with progressive and calcified internal carotid critical stenosis.

According to the company, the procedure was successfully performed with the 10- X 30-mm CGuard EPS and obtained an excellent angiographic result. After the procedure, Dr. Schmidt commented, “The CGuard EPS stent has superb conformability with its open-cell design, and having the MicroNet mesh technology gives my patient the greatest protection available in carotid stenting.”