US-based medical technology company Vantis Vascular has received the US Food and Drug Administration (FDA) 510(k) approval for its CrossFAST Guide Extension System.
The integrated microcatheter guide extension system is designed to simplify the delivery of therapeutic devices to distal coronary or peripheral anatomies.
Vantis intends to commercially launch the CrossFAST system in the US in Q4 2024 in a limited market release, with plans for a full market release in 2025.
CrossFAST is the first and only dual monorail microcatheter system specifically designed for complex coronary and peripheral interventions, said the medical technology company.
Vantis CMO Tim Fischell said: “At Vantis, our goal is to revolutionise the way we navigate complex, calcified and tortuous anatomy.
“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.”
According to the company, guide extension catheters play a key role in vascular interventions, facilitating device delivery in challenging anatomies and complex high-risk cases.
Conventional guide extension catheters are constrained by insufficient pushability and a risk of vessel trauma during delivery.
Vantis said that its CrossFAST Guide Extension System is purpose-built to provide superior safety and deliverability, enhancing interventional procedures.
It is powered by the company’s patented DuoPro Interlocking Technology, a novel mechanism that combines the outer and inner extension catheters.
Vantis CEO Jason Turner said: “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.
“Our team has worked tirelessly to develop a solution that not only enhances the capabilities of interventional cardiologists but also prioritises patient safety.
“The CrossFAST System reflects our commitment to addressing the real challenges physicians face in complex interventions, ultimately enabling better patient outcomes.”