Vantis Vascular Receives FDA Clearance for 6F CrossFAST Model

New 6 French model accommodates a broader range of devices while maintaining the integrated design and deliverability of CrossFAST

SAN JOSE, Calif., Oct. 13, 2026 /PRNewswire/ -- Vantis Vascular, a medical technology company developing innovative devices for vascular interventions, today announced U.S. Food and Drug Administration (FDA) 510(k) clearance for a new 6 French (6F) model of its CrossFAST® Integrated Microcatheter Advanced Delivery System.

The new 6F CrossFAST features a larger lumen designed to accommodate a broader range of interventional devices and a shorter distal tip for complex percutaneous coronary intervention (PCI) procedures. The 6F model will be commercially available in November alongside the existing 5.5F model, providing physicians with two CrossFAST options based on their procedural needs. Both models build on the integrated design and deliverability of CrossFAST, which is engineered to help interventional cardiologists navigate challenging anatomies.

"The new CrossFAST model represents an important expansion of technology designed around the needs of interventional cardiologists," said Jason Turner, Chief Executive Officer 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."

The larger lumen of the 6F CrossFAST accommodates a broader range of interventional technologies used in complex PCI, including intravascular ultrasound (IVUS) and intravascular lithotripsy (IVL). The new model is designed 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, MD, 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."

CrossFAST 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. The new CrossFAST model received FDA 510(k) clearance under K262817 on September 18, 2026.

About CrossFAST

CrossFAST® Integrated Microcatheter Advanced Delivery System is engineered to help interventional cardiologists navigate challenging anatomies when performing complex PCI procedures. Powered by DuoPRO™ Interlocking Technology, CrossFAST couples an inner monorail microcatheter with an outer delivery catheter, allowing the system to advance as one unit. CrossFAST has been commercially available in the United States since January 2025, with the new 6F model expanding the platform alongside the existing 5.5F model.

About Vantis Vascular

Vantis Vascular® is a privately held medical technology company developing innovative medical devices designed to help interventional cardiologists confidently and efficiently treat complex cases. Founded by physicians, the company is focused on developing performance-driven technologies that help physicians go faster and further during coronary interventions. Vantis Vascular is based in San Jose, California. Learn more at www.vantisvascular.com.

Vantis Vascular and CrossFAST are registered trademarks of Vantis Vascular, Inc. DuoPRO is a trademark of Vantis Vascular, Inc.

SOURCE Vantis Vascular, Inc.