MicroVention’s Sofia 6-F Aspiration System Studied in SOFAST as a First-Line Technique for AIS

July 9, 2024—MicroVention, Inc., a neurovascular company and wholly owned subsidiary of Terumo Corporation, announced the publication of findings from the SOFAST study.

According to the company, SOFAST assessed the efficacy and safety of the company’s Sofia 6-F flow plus aspiration catheter system as a first-line technique for endovascular thrombectomy to treat acute ischemic stroke (AIS) caused by large vessel occlusion. The United States prospective, multicenter study enrolled 108 patients and aimed to confirm the catheter’s safety, speed, and effectiveness in revascularization.

Results from the SOFAST study were published by Dheeraj Gandhi, MD, et al online in the Journal of NeuroInterventional Surgery (JNIS).

As summarized by MicroVention, the study included data on the following attributes for the Sofia 6-F device:

• Speed: 12-minute median groin puncture to clot contact time and 17-minute median groin puncture to recanalization time.
• Efficacy: 75% first-pass modified Treatment In Cerebral Ischemia (mTICI) ≥ 2b using the device.
• Safety: 0% embolization to new territories and symptomatic intracranial hemorrhage rate within 24 hours.
• Clinical Outcomes: 66.7% of patients experienced good functional outcomes at 90 days.

The company advised that the comprehensive set of specific data points and outcomes are available in the published study.

“The efficacy and safety data from this prospective, multicenter, independent core-lab adjudicated SOFAST study are very impressive and set a new innovation standard,” commented Dr. Gandhi in the company’s press release. “High rates of mTICI ≥ 2b (97.2%) revascularization at the procedure end, 70.4% rate of mTICI 2c or better after the first pass, median time to recanalization of 17 minutes, and 66.7% rate of good clinical outcomes are amongst the very best metrics reported with contemporary thrombectomy devices.”

Dr. Gandhi is with the University of Maryland School of Medicine in Baltimore, Maryland, where he is Vice Chairman for Academic Affairs; Director, Interventional Neuroradiology; Director, CMIT Center (Center for Metabolic Imaging and Therapeutics); Professor of Radiology, Neurology and Neurosurgery.