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FDA Grants 510 (k) Clearance To Pathway Medical’s Jetstream G2 System

Pathway Medical Technologies, Inc. announced that it has received the 510 (k) clearance to market its Jetstream G2 system from the US FDA. This novel peripheral atherectomy catheter is designed to be used in the treatment of PAD in the lower limbs. Jetstream G2 is the latest technology innovation which is capable of treating the entire spectrum of disease found in the PAD patient, including hard and soft plaque, calcium, thrombus and fibrotic lesions, with consistent results. Jetstream G2 delivers design enhancements from the First-Generation Jetstream Catheter includes: • Proximal Aspiration Port — The Jetstream G2 aspiration port is now separate from the cutting mechanism and located just proximal to the expandable cutting blades. As a result, the G2 provides greater aspiration efficiency and a more than 50 percent improvement in crossing time as compared to the Jetstream. In addition, a larger aspiration port allows for larger particles to be immediately removed from the treatment area. • Masticating System — Located within the new aspiration port is an internal masticating system. Positioned at the distal end of the catheter’s internal aspiration lumen, the system is fully recessed to ensure no contact with the artery walls during use and, importantly, helps break aspirated material into smaller pieces before removal through the aspiration port.