August 28, 2018
Terumo's MicroVention Casper Carotid Stent Evaluated for Safety and Efficacy at 90 Days
August 29, 2018—In a retrospective analysis of prospectively collected data evaluating the safety and efficacy of the Casper carotid stent (MicroVention, Inc., a subsidiary of Terumo), the device demonstrated safety and efficacy in the treatment of carotid stenosis with no technical failures and no adverse neurological events in the 90-day follow-up period. Casper's double-layer structure combines adequate plaque scaffolding with high vessel adaptability, concluded Sebastian J. Mutzenbach, MD, et al in Journal of NeuroInterventional Surgery (JNIS; 2018;10:869–873).
As summarized in JNIS, the study was composed of 138 patients (25.4% women; median age, 71 years) who underwent Casper stent implantation for carotid artery stenosis between January 2014 and February 2017. Eligibility criteria included stenosis > 70% of vessel diameter (or > 50% diameter with ulceration) in symptomatic patients or asymptomatic patients with > 80% stenosis at the carotid bifurcation or in the proximal internal carotid artery. A distal embolic protection device was used for all procedures.
The primary endpoint was the rate of 90-day major adverse neurological events, defined as minor stroke, major stroke, or death by independent neurological assessment.
The investigators reported the following in JNIS:
- Stent deployment was successfully completed in all cases without documented technical failure.
- During a procedure, there was one thromboembolic occlusion of a small distal branch of the anterior cerebral artery that was resolved with administration of systemic recombinant tissue plasminogen activator.
- At 90 days, there were no adverse neurological events or mortalities.
- Postprocedure cerebral MRI showed new ischemic lesions, all clinically silent, in 6.5% of patients.
In July, Erasmia Broussalis, MD, et al published findings from a study online in JNIS that concluded that using the Casper stent in combination with a distal embolic protection device is safe and results in a lower rate of periprocedural cerebral diffusion-weighted imaging lesion burden compared with reported results for historic controls. The Caspar device is not cleared nor approved by the FDA for sale or use in the United States.