#USA #San Jose #FDA Clearance #Vantis Vascular #CrossFAST

Vantis Vascular Unveils 6F CrossFAST Model

Vantis Vascular, a trailblazer in medical technology focused on vascular interventions, has recently announced a major milestone. The company has received FDA 510(k) clearance for its new 6 French (6F) model of the CrossFAST® Integrated Microcatheter Advanced Delivery System. Set to be launched commercially by November of this year, the 6F model introduces a range of enhancements that address the evolving needs of interventional cardiologists.

Advancements in Design

The new 6F CrossFAST model features a larger lumen, allowing for the accommodation of a broader spectrum of interventional devices, which can significantly improve the efficacy of complex percutaneous coronary intervention (PCI) procedures. This advancement not only enables the use of more sophisticated interventional technologies but also includes a shorter distal tip design that enhances maneuverability in challenging anatomical structures.

Jason Turner, the CEO of Vantis Vascular, highlighted the importance of this clearance, stating, “The new CrossFAST model represents an important expansion of technology designed around the needs of interventional cardiologists. 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.”

Enhanced Clinical Utility

The larger lumen of the 6F CrossFAST is engineered to facilitate the integration of various advanced technologies such as intravascular ultrasound (IVUS) and intravascular lithotripsy (IVL). The incorporation of these technologies is critical for performing complex PCI cases, thereby improving patient outcomes.

Dr. Jasvindar Singh, a prominent interventional cardiologist at Washington University and Barnes-Jewish Hospital, expressed enthusiasm about the new model, stating, “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’s Proven Technology

Designed for optimal performance, CrossFAST utilizes DuoPRO™ Interlocking Technology, which seamlessly combines an inner monorail microcatheter with an outer delivery catheter. This unique structure allows the system to advance as a single unit, thereby enhancing efficiency during coronary interventions. The CrossFAST platform has been available in the U.S. since January 2025, and the addition of the 6F model further solidifies its position as a reliable tool in the hands of interventional cardiologists.

Company Background

Founded by a group of physicians dedicated to advancing medical technology, Vantis Vascular is committed to developing innovative devices that empower interventional cardiologists to tackle complex cases confidently and effectively. By focusing on performance-driven technologies, Vantis aims to help healthcare professionals deliver faster and more efficient care, making a significant impact in the realm of coronary interventions.

As the healthcare landscape continues to evolve, advancements such as the new 6F CrossFAST model not only reflect Vantis Vascular’s dedication to innovation but also highlight the importance of maintaining high standards in medical technology that enhance clinical outcomes. Vantis Vascular maintains its commitment to progress and is keen on pushing the boundaries of what's possible in vascular interventions. For more information, individuals can visit Vantis Vascular.