MicroVention Announces Clinical Publication of SOFAST: SOFIA™ Aspiration System as First Line Technique in Treating Acute Ischemic Stroke

MicroVention, Inc., a global neurovascular company and wholly owned subsidiary of Terumo Corporation, announced the publication of the 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, recently published in the Journal of NeuroInterventional Surgery (JNIS).

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MicroVention Announces Clinical Publication of SOFAST: SOFIA™ Aspiration System as First Line Technique in Treating Acute Ischemic Stroke (Graphic: Business Wire)

The SOFAST study 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. The long-standing legacy of SOFIA is reinforced by the important data points observed in this publication emphasizing the following:

• Speed: 12-minute median groin puncture to clot contact time and 17-minute median groin puncture to recanalization time.
• Efficacy: 75% First Pass mTICI≥2b using SOFIA 6F.
• Safety: 0% embolization to new territories and symptomatic intracranial hemorrhage rate within 24h.
• Clinical Outcomes: 66.7% of patients experienced good functional outcomes at 90 days.

Please reference the publication for a comprehensive set of data points and outcomes.

“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.

“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,” said Carsten Schroeder, President and CEO, MicroVention, Inc. “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.”

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+ articles published globally since it was first introduced more than ten years ago. Designed for speed to target, clot engagement, kink resistance and a confident first pass, SOFIA Flow Plus Aspiration Catheters continue to set the pace in treating acute ischemic stroke.

From access to revascularization, MicroVention now 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.

About MicroVention, Inc.

Founded in 1997, MicroVention develops and markets medical devices that enable or significantly improve treatment of cerebrovascular diseases. In 2006, Terumo Corporation, a major worldwide medical device company headquartered in Tokyo, Japan, acquired MicroVention into their family of Companies. Terumo’s acquisition of MicroVention allowed both Companies to leverage their unique, proprietary technologies toward an increased focus on treating cerebrovascular diseases. Headquartered in California, MicroVention products are today sold in more than seventy countries through a direct sales organization alongside strategic distribution partnerships. Manufacturing facilities are in Aliso Viejo, California and San José, Costa Rica. For more information on MicroVention, please visit www.microvention.com.

About Terumo Corporation

Terumo (TSE:4543) is a global leader in medical technology and has been committed to "Contributing to Society through Healthcare" for 100 years. Based in Tokyo and operating globally, Terumo employs more than 30,000 Associates worldwide to provide innovative 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. Terumo will further strive to be of value to patients, medical professionals, and society at large. For more information on Terumo, please visit www.terumo.com/about/profile.

** Editor’s Note: For a Clinical Glossary of Terms, please visit https://www.microvention.com/clinical-education/glossary.

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