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Vantis Vascular Expands CrossFAST Platform with 6F FDA Clearance

San Jose-based Vantis Vascular has secured FDA 510(k) clearance for a 6 French model of its CrossFAST system, a move designed to broaden the range of compatible devices for complex coronary interventions. The new model joins the existing 5.5F version, aiming to streamline procedure times for interventional cardiologists.

Vantis Vascular Expands CrossFAST Platform with 6F FDA Clearance

The 6F CrossFAST model features an enlarged lumen and a shortened distal tip, modifications specifically engineered to accommodate advanced diagnostic tools such as intravascular ultrasound (IVUS) and intravascular lithotripsy (IVL). By allowing these technologies to pass through the catheter more effectively, the system seeks to provide physicians with greater flexibility when navigating challenging vascular anatomies.

Dr. Jasvindar Singh of Washington University and Barnes-Jewish Hospital noted that the increased lumen size directly addresses a need for better device compatibility in complex percutaneous coronary intervention (PCI) cases. The platform utilizes the company's proprietary DuoPRO Interlocking Technology, which couples an inner monorail microcatheter with an outer delivery catheter to function as a single unit. Commercial availability for the 6F model is scheduled for November, following its regulatory clearance on September 18, 2026.

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