ARTESp Study Demonstrates Safety and Efficacy of Phenox Preset Thrombectomy Device

September 28, 2016—Phenox GmbH announced that results of the ARTESp study were recently published online ahead of print by Sascha Prothmann, MD, et al in the Journal of NeuroInterventional Surgery. The ARTESp (Acute Recanalization of Thrombo-Embolic Ischemic Stroke With the Phenox Preset) study investigators reported the impact of occlusion time on clinical outcome of directly admitted and transferred patients with ischemic stroke treated with the company’s Preset thrombectomy retriever device.

The prospective, multicenter, single-arm, postmarket clinical follow-up study evaluated the efficacy, safety, and long-term outcomes of mechanical thrombectomy using the Preset thrombectomy device. The study included patients with acute proximal occlusions of major cerebral vessels of both the anterior and posterior circulation.

The study was composed of 100 patients with 109 acute intracranial vessel occlusions. The average age of the patients was 68.3 years, and they presented with a mean National Institutes of Health Stroke Scale of 15. The rate of vessel recanalization (Thrombolysis in Cerebral Infarction, 2b/3) was 84.4%. After 90 days, 62.5% of the patients had a positive clinical outcome and were free of severe, neurological deficits (modified Rankin Scale 0–2). The mortality rate was 7%.

According to the company, the ARTESp study mirrors and reinforces the findings of the four randomized controlled trials composed of patients with proximal large-vessel occlusions (MR CLEAN, SWIFT-PRIME, EXTEND-IA, ESCAPE) that have demonstrated that the treatment of mechanical thrombectomy represents a highly effective therapy for acute ischemic stroke.

The company also advised that the Preset and Preset Lite thrombectomy devices are now included in the SITS Open study. Under the direction of the Neuroscientific Department at Karolinska Institute in Stockholm, Sweden, SITS open is comparing the stand-alone use of intravenous thrombolysis to mechanical thrombectomy.