MicroVention’s Bold Move into Cutting-Edge Transradial Access Therapy: FDA Greenlights SOFIA™ EX 5F 115cm Intracranial Support Catheter

MicroVention Makes Waves in Neurovascular Advancements: FDA Gives Green Light to SOFIA™ EX 5F Catheter for Transradial Access

ALISO VIEJO, Calif.–(BUSINESS WIRE)– In a groundbreaking move, MicroVention, Inc., a global leader in neurovascular solutions under Terumo Corporation, has received the coveted FDA 510(k) clearance for its SOFIA™ EX 5F 115 cm Intracranial Support Catheter. This remarkable catheter, designed for both transradial and transfemoral access, is set to redefine neurointervention.

The SOFIA™ EX 5F Catheter boasts a unique design, combining exceptional trackability with a spacious inner lumen for swift and efficient access to intracranial sites. Reinforced with a nitinol coil and stainless-steel braid, it offers unparalleled support and kink resistance. With an inner PTFE liner spanning its entire length and 12 optimized transition zones for superior pushability, this catheter is a game-changer.

Transradial access, a wrist-based approach, offers a dynamic alternative to the traditional transfemoral access via the groin. The FDA’s clearance of SOFIA™ EX 5F for radial access signifies a significant milestone, marking MicroVention’s foray into this cutting-edge domain. MicroVention believes in empowering healthcare providers to have unwavering confidence in the SOFIA™ EX 5F, whether they choose the transradial or transfemoral path.

Carsten Schroeder, CEO of MicroVention, expressed their delight, stating, “We are thrilled to secure FDA clearance for MicroVention’s SOFIA™ EX 5F Intracranial Support Catheter for transradial access. This achievement reflects our steadfast dedication to advancing radial neurointervention and underscores our relentless pursuit of innovation, all in the name of enhancing healthcare and saving lives.”

This clearance heralds a new era in neurovascular care, with MicroVention leading the charge towards safer, more effective treatments.

About MicroVention, Inc.

In the realm of cerebrovascular disease treatment, one company stands as a beacon of progress – MicroVention. Established in 1997, MicroVention has been at the forefront of developing and introducing groundbreaking medical devices that not only enable but also significantly enhance the treatment of cerebrovascular diseases.

The turning point came in 2006 when Terumo Corporation, a renowned global leader in medical devices with its headquarters in Tokyo, Japan, welcomed MicroVention into its illustrious family of companies. This strategic partnership paved the way for both entities to harness their unique and proprietary technologies, amplifying their dedication to combating cerebrovascular diseases.

Based in the innovation hub of California, MicroVention’s products have now traversed borders and are available in over seventy countries. Their global presence is bolstered by a dynamic direct sales force and strategic distribution partnerships that ensure their pioneering medical solutions reach those in need.

With manufacturing facilities situated in Aliso Viejo, California, and San José, Costa Rica, MicroVention continues to lead the charge in revolutionizing cerebrovascular care. Their unwavering commitment to innovation and excellence exemplifies their mission to transform the landscape of healthcare worldwide.

About Terumo Corporation

For a remarkable century, Terumo (TSE:4543) has been an unwavering force in the realm of medical technology, dedicated to the noble cause of “Contributing to Society through Healthcare.” From its origins as a humble Japanese thermometer manufacturer, Terumo has evolved into a global leader headquartered in the vibrant heart of Tokyo.

With a presence spanning more than 160 countries and regions, Terumo’s mission comes to life through the tireless efforts of over 28,000 associates worldwide. Their collective goal is to revolutionize healthcare by delivering cutting-edge medical solutions that empower patients and medical professionals alike.

Terumo’s diverse business portfolio reflects its commitment to enhancing lives. From pioneering vascular intervention and cardio-surgical advancements to trailblazing blood transfusion and cell therapy technologies, Terumo’s innovations have reshaped the medical landscape. Moreover, their contributions extend to everyday clinical practice, with essential medical products spanning transfusion systems, diabetes care, and peritoneal dialysis treatments.

As they embark on the next chapter of their illustrious journey, Terumo remains steadfast in their mission to bring value not only to patients and healthcare providers but to society as a whole. With innovation as their compass, they are poised to continue their transformative impact on the world of healthcare.

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