Peripheral Atherectomy Catheter Gains CE Mark

 

December 15, 2009

December 15, 2009 – CE Mark approval has been granted for Pathway Medical Technologies’ Jetstream G2TM NXT System, a peripheral atherectomy catheter for use in the treatment of PAD.

In August, Pathway Medical announced 510(k) clearance from the U.S. Food and Drug Administration (FDA) to market the Jetstream G2 NXT. The atherectomy catheter designed to remove all types of artery-clogging plaque in the lower limbs of patients. It offers specific design enhancements to Pathway’s first-generation device, improving options for physicians treating PAD. This innovative and minimally invasive solution clears blockages in the peripheral vasculature, restores blood flow and effectively treats PAD.

Jetstream G2 NXT consists of a sterile, single-use catheter and control pod and a reusable, compact console that mounts to a standard I.V. stand. The catheter has an expandable cutting tip that safely debulks and preemptively removes both hard and soft plaque, as well as calcium, thrombus and fibrotic lesions. A highly efficient aspiration port located just proximal to the cutting blades continually removes excised tissue and thrombus from the treatment site to a collection bag located on the console. A fully recessed masticating system within the aspiration port helps break aspirated material into smaller pieces before removal, providing significant benefits for the treating physician and patient while ensuring no contact with the artery walls. The distal portion of the catheter also possesses infusion ports that provide continuous infusion of sterile saline during the atherectomy procedure. The company said active aspiration is a safety feature that minimizes the risk of distal embolization.

For more information: www.pathwaymedical.com