Vantis Vascular’s 6-F CrossFast System Receives FDA Clearance 

October 14, 2026—Vantis Vascular announced FDA 510(k) clearance for a new 6-F model of its CrossFast integrated microcatheter advanced delivery system. The 6-F model will be commercially available in November, advised the company.

According to the company, the CrossFast system is intended to be used in conjunction with guide catheters to access discrete regions of the coronary and/or peripheral vasculature and facilitate placement of interventional devices. Along with its 5.5-F model, CrossFast now provides two options based on the interventionists’ procedural needs for navigating challenging anatomies.

Vantis Vascular stated that the larger lumen and shorter distal tip of the 6-F CrossFast accommodates a broader range of interventional technologies used in complex percutaneous coronary intervention (PCI) procedures, including intravascular ultrasound (IVUS) and intravascular lithotripsy (IVL).

“IVUS is critical in complex PCI cases, and its use has continued to grow over the years,” commented Jasvindar Singh, MD, in the Vantis Vascular press release. “I am excited about the new 6F CrossFast model because the larger lumen accommodates IVUS and a broader range of interventional technologies, allowing me to use CrossFast in more of the complex cases I perform.”

Dr. Singh is Professor of Medicine and an interventional cardiologist at Washington University and Barnes-Jewish Hospital in St. Louis, Missouri.