VANTIS VASCULAR RECEIVES FDA CLEARANCE FOR ITS CROSSFAST™ GUIDE EXTENSION SYSTEM

First and Only Dual Monorail Microcatheter System Purpose-Built for Complex Coronary and Peripheral Interventions

SAN JOSE, Calif., Oct. 25, 2024 /PRNewswire/ -- Vantis Vascular, Inc., a pioneering medical technology company founded by physicians with a passion to revolutionize vascular interventions, today announced it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for its CrossFAST Integrated Microcatheter Guide Extension System to help physicians perform faster, easier and safer procedures.

"At Vantis, our goal is to revolutionize the way we navigate complex, calcified and tortuous anatomy," commented Tim Fischell, MD, Chief Medical Officer at Vantis. "A significant need exists to improve upon existing guide extension catheters given anatomical challenges and the fact that complex high-risk patients are becoming the norm. The CrossFAST System is designed for smooth and effortless deliverability and has the potential to be game-changing in reaching the target location."

Guide extension catheters play a crucial role in vascular interventions by providing additional support and facilitating device delivery in challenging anatomies and complex high-risk cases. Traditional guide extension catheters are limited by insufficient pushability and risk of vessel trauma during delivery. Powered by patented DuoPro™ Interlocking Technology, a novel mechanism that couples the outer and inner extension catheters, the CrossFAST Guide Extension System is purpose-built for safety and unparalleled deliverability, enhancing interventional procedures from start to finish.

"We are thrilled to receive FDA clearance for our innovative guide extension system, marking a significant milestone in our mission to transform the way physicians navigate complex and calcific anatomy," said Jason Turner, Chief Executive Officer at Vantis. "Our team has worked tirelessly to develop a solution that not only enhances the capabilities of interventional cardiologists but also prioritizes patient safety. The CrossFAST System reflects our commitment to addressing the real challenges physicians face in complex interventions, ultimately enabling better patient outcomes."

The CrossFAST Guide Extension System will be commercially available in the United States in Q4 2024 as part of a limited market release. Full market release is planned in 2025.

About Vantis Vascular:

Vantis Vascular, Inc. is a medical technology company dedicated to revolutionizing vascular interventions. Founded by physicians, Vantis develops performance-driven technologies that aim to provide faster, safer and more effective treatments to patients. With a focus on innovation and patient-centric solutions, Vantis is committed to advancing the field of interventional cardiology and improving patient outcomes worldwide.

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SOURCE Vantis Vascular, Inc.