Aliso Viejo, California, September 21,2023 – MicroVention, Inc., a global neurovascular company and wholly owned subsidiary of Terumo Corporation, today announced that the SOFIA™ EX 5F 115 cm Intracranial Support Catheter (Soft TOrqueable catheter For Intracranial Access) has received FDA 510(k) clearance on September 15, 2023, for transradial access in addition to transfemoral access. The unique design of the SOFIA™ EX 5F Catheter allows for great trackability and a large inside lumen provides a fast and effective way for tracking to intracranial locations in patients. Reinforced with a nitinol coil and stainless-steel braid, SOFIA™ EX offers support and kink resistance. The catheter has an inner PTFE liner throughout the entire length with 12 transition zones optimized for pushability.
Transradial access utilizes the radial artery in the wrist as opposed to the femoral artery in the groin in transfemoral access. The SOFIA™ EX 5F radial access clearance proudly marks MicroVention’s first radial access product and signifies our commitment to innovation. MicroVention believes providers should have the ability to feel confident in our SOFIA™ EX 5F in either the transradial or transfemoral access approach.
“We are pleased to receive FDA clearance for MicroVention’s SOFIA™ EX 5F Intracranial Support Catheter for transradial access,” said Carsten Schroeder, CEO, MicroVention. “This achievement signifies our commitment to radial neurointervention and represents our unwavering commitment to improving healthcare and helping to save patient lives, while striving to be at the forefront of innovation.”
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 one hundred years. Based in Tokyo and operating globally, Terumo employs more than 28,000 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 such as transfusion systems, diabetes care, and peritoneal dialysis treatments. 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.
Global Corporate Communications
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** Editor’s Note: For a Clinical Glossary of Terms, please visit https://www.microvention.com/clinical-education/glossary.
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