Pathway Medical Technologies has received the US Food and Drug Administration (FDA) 510(k) clearance for its JETSTREAM Navitus, a revascularization catheter for the treatment of peripheral vascular disease (PVD).
JETSTREAM 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 a cutting tip which removes both hard and soft plaque, as well as calcium, thrombus and fibrotic lesions.
Excised tissue and thrombus are continually aspirated from the peripheral treatment site through a port in the catheter tip to a collection bag located on the console.
The distal portion of the catheter also possesses infusion ports that provide continuous infusion of sterile saline during the atherectomy procedure.
JETSTREAM Navitus new features and benefits include improved performance in tortuous anatomy, effective therapy for calcium and chronic total occlusions (CTOs), active aspiration which allows the operator to continually aspirate (remove) excised tissue and thrombus while the device is operating
Navitus features expandable blade technology that enables treatment of blockages from the superficial femoral artery to below the knee, empowering physicians to treat all lesion morphologies.