Vantis Vascular, a US-based medical technology company, has received 510(k) clearance from the US Food and Drug Administration (FDA) for a new 6 French (6F) model of its CrossFAST Integrated Microcatheter Advanced Delivery System.
The new 6F CrossFAST features a larger lumen to accommodate a broader range of interventional devices and a shorter distal tip to support complex percutaneous coronary intervention (PCI) procedures.
The company plans to make the new model commercially available in November 2026, alongside the existing 5.5F model. The two options are intended to give physicians greater flexibility in selecting a system based on their procedural requirements.
Both models retain CrossFAST’s integrated design and deliverability, which are intended to help interventional cardiologists navigate challenging vascular anatomies.
“The new CrossFAST model represents an important expansion of technology designed around the needs of interventional cardiologists,” said Jason Turner, CEO of Vantis Vascular.
“With the addition of the 6F model, we are expanding the versatility of the CrossFAST platform while maintaining the integrated design and deliverability physicians have come to expect. This is another step toward our goal of helping physicians go faster and further during coronary interventions,” he added.
New Model to Support Complex PCI Procedures
According to Vantis Vascular, the larger lumen of the 6F CrossFAST is designed to accommodate a wider range of interventional technologies used in complex PCI, including intravascular ultrasound (IVUS) and intravascular lithotripsy (IVL). This is expected to provide physicians with greater flexibility when treating challenging coronary anatomy.
“IVUS is critical in complex PCI cases, and its use has continued to grow over the years,” said Jasvindar Singh, Professor of Medicine and interventional cardiologist at Washington University and Barnes-Jewish Hospital in St. Louis, Missouri.
“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,” he added.
The CrossFAST system can be used in combination with guide catheters to access discrete regions of the coronary and/or peripheral vasculature and facilitate placement of interventional devices. The new 6F model received FDA 510(k) clearance under K262817 on September 18, 2026.
Headquartered in San Jose, California, Vantis Vascular develops medical devices for vascular interventions. Its CrossFAST Integrated Microcatheter Advanced Delivery System is designed to help interventional cardiologists navigate challenging anatomies during complex PCI procedures.
Powered by DuoPRO Interlocking Technology, CrossFAST combines an inner monorail microcatheter with an outer delivery catheter, enabling the two components to advance as a single unit. The system has been commercially available in the United States since January 2025, and the new 6F model expands the platform alongside the existing 5.5F option.
