Vantis Vascular announced today that it received FDA 510(k) clearance for its CrossFast integrated microcatheter guide extension system.
San Jose, California-based Vantis develops the CrossFast system along with the CrossShock intravascular lithotripsy (IVL) system. It designed CrossFast to help physicians perform faster, easier and safer procedures. The guide extension catheter offers additional support and facilitates device delivery in challenging anatomies and complex, high-risk cases.
According to Vantis, limitations of traditional guide extension catheters include insufficient pushability and risk of vessel trauma. CrossFast features patented DuoPro interlocking technology that couples the outer and inner extension catheters. This offers safety and deliverability, enhancing interventional procedures from start to finish.
Dr. Tim Fischell, Vantis chief medical officer, outlined a need to improve upon existing guide extension catheters. In a news release, Fischell called CrossFast potentially “game-changing in reaching the target location.”
Vantis expects to make CrossFast available in the U.S. through a limited release in the fourth quarter of 2024. It plans for a full market launch in 2025.
“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, Vantis CEO. “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.”
