Multi-Center Study Reinforces Efficacy of MicroVention’s SOFIA Catheter

Global neurovascular firm MicroVention Inc. is sharing clinical trial data that further validates its SOFIA Catheter line’s capabilities in treating acute ischemic stroke.

Published in the Journal of NeuroInterventional Surgery (JNIS), the study—SOFIA Aspiration System as first-line Technique (SOFAST): A prospective, multicenter study to assess the efficacy and safety of the 6 French SOFIA Flow Plus Aspiration Catheter for endovascular stroke thrombectomy—assessed the SOFIA Flow Plus Aspiration Catheter (SOFIA 6F) for treating acute ischemic stroke caused by large vessel occlusion. This U.S. prospective, multicenter study involved 108 patients and aimed to confirm the catheter’s safety, speed and effectiveness in revascularization. Among the conclusions reached in the trial: 

• A 12-minute median groin puncture to clot contact time and 17-minute median groin puncture to recanalization time.
• Seventy-five percent First Pass mTICI≥2b using SOFIA 6F.
• No embolization to new territories and symptomatic intracranial hemorrhage rate within 24 hours.
• Nearly 67% of patients experienced good functional outcomes at 90 days.
• At the end of the procedure, 97.2%, 85.2%, and 55.6% of patients achieved mTICI≥2b, ≥2c, and 3, respectively.
• With SOFIA 6F first-line aspiration, 87.0%, 79.6%, and 52.8% achieved mTICI≥2b, ≥2c, and 3, respectively.
• Roughly 18.5% of patients (20/108) crossed over to other devices during the thrombectomy procedure. 

“The efficacy and safety data from this prospective, multi-center, independent core-lab adjudicated SOFAST study are very impressive and sets a new innovation standard. 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,” said Dr. Dheeraj Gandhi, vice chairman for Academic Affairs; director, Interventional Neuroradiology; director, CMIT Center (Center for Metabolic Imaging and Therapeutics); professor of Radiology, Neurology and Neurosurgery, University of Maryland School of Medicine.

MicroVention also recently celebrated a decade of legacy innovation commemorating the anniversary of SOFIA and SOFIA Flow Plus Aspiration Catheters, with more than half a million worldwide procedures performed across 170 countries, and 30-plus articles published globally since it was first introduced more than 10 years ago.The SOFIA Flow Plus Aspiration Catheter is designed for speed to target, clot engagement, kink resistance and a confident first pass, according to MicroVention. 
 
“The SOFAST Study further underscores that our SOFIA Aspiration Catheters have set the standard for more than a decade with its renowned trackability, speed and now with further proven clinical performance,” MicroVention President/CEO Carsten Schroeder stated. “We will continue to participate in critical clinical research such as SOFAST, work side-by-side with leading physicians around the world to identify the evolving needs in patient care, and then transform those insights into innovative technologies that help to save patient lives.”
 
From access to revascularization, MicroVention offers a fully integrated and streamlined portfolio of stroke solutions including SOFIA, SOFIA Flow Plus Aspiration Catheters, as well as ERIC Retrieval Device, BOBBY Balloon Guide Catheter, WEDGE Microcatheter, HEADWAY Microcatheters and TRAXCESS Guidewires.
 
Founded in 1997, MicroVention develops and markets medical devices that enable or significantly improve cerebrovascular disease treatment. In 2006, Terumo Corporation acquired MicroVention, allowing both companies to leverage their proprietary technologies toward an increased focus on treating cerebrovascular diseases. Headquartered in California, MicroVention products are sold in more than 70 countries through a direct sales organization alongside strategic distribution partnerships. Manufacturing facilities are in Aliso Viejo, Calif., and San José, Costa Rica. 
 
Tokyo-based Terumo is a global leader in medical technology and employs more than 30,000 associates worldwide to provide medical solutions in more than 160 countries and regions. The company started as a Japanese thermometer manufacturer and has been supporting healthcare ever since. Now, its extensive business portfolio ranges from vascular intervention and cardio-surgical solutions, blood transfusion and cell therapy technology, to medical products essential for daily clinical practice.