Vantis Vascular, Inc., a medical technology company, has announced that it received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for its CrossFAST Integrated Microcatheter Guide Extension System. This system is designed to aid physicians in performing faster, easier, and safer vascular procedures, particularly in complex coronary and peripheral interventions.
CrossFAST System Design and Technology
The CrossFAST system is engineered for smooth deliverability, aiming to improve access to target locations in challenging anatomies. According to Tim Fischell, MD, Chief Medical Officer at Vantis, the system addresses the need for improved guide extension catheters, especially given the increasing prevalence of complex high-risk patients. The system incorporates patented DuoPro Interlocking Technology, a mechanism that couples the outer and inner extension catheters, enhancing safety and deliverability throughout interventional procedures.
Clinical Significance and Availability
Guide extension catheters are crucial in vascular interventions, providing support and facilitating device delivery in difficult anatomies. Traditional catheters often lack sufficient pushability and can risk vessel trauma. The CrossFAST system aims to overcome these limitations, potentially improving patient outcomes by enabling more effective navigation in complex cases. Jason Turner, Chief Executive Officer at Vantis, emphasized the company's commitment to addressing the challenges physicians face in complex interventions and improving patient safety.
The CrossFAST Guide Extension System is slated for commercial availability in the United States in Q4 2024, beginning with a limited market release. A full market release is planned for 2025.
