Medical technology company Vantis Vascular announced on Tuesday that it 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 designed to accommodate a broader range of interventional devices and a shorter distal tip for complex percutaneous coronary intervention (PCI) procedures. It will be commercially launched in November.

The larger lumen of the 6F CrossFAST accommodates a wide 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.

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 6F model will be available alongside the existing 5.5F model, providing physicians with two CrossFAST options based on their procedural needs.