FDA clears updated Pathway peripheral atherectomy catheter

Pathway Medical Technologies, a provider of endovascular treatments for peripheral arterial disease (PAD), has received FDA 510(k) clearance to market its peripheral atherectomy catheter for use in the treatment of PAD in the lower limbs.

Jetstream G2 is capable of treating the spectrum of disease found in the PAD patient, including hard and soft plaque, calcium, thrombus and fibrotic lesions, according to the Kirkland, Wash.-based company.

Pathway said that the new design features of Jetstream G2 include:

  • Proximal Aspiration Port: The port is now separate from the cutting mechanism and located just proximal to the expandable cutting blades. Also, a larger aspiration port allows for larger particles to be removed from the treatment area.
  • Masticating System: Located within the new aspiration port, and positioned at the distal end of the catheter’s internal aspiration lumen, so the system is recessed to ensure no contact with the artery walls during use and, helps break aspirated material into smaller pieces before removal through the aspiration port.