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January 12, 2010
FDA Grants 510(k) Clearance for Pathway's Jetstream G3
January 13, 2010—Pathway Medical Technologies, Inc. (Kirkland, WA) announced that the US Food and Drug Administration has granted 510(k) clearance to market the company's Jetstream G3 peripheral revascularization catheter for treating peripheral vascular disease. The device is designed to remove all kinds of artery-clogging plaque in the lower limbs of patients. The Jetstream G3 includes a new distal cutter and enhanced aspiration efficiency for a significant improvement in cutting and removing disease as compared to previous versions. Jetstream G3 is used to treat the entire spectrum of disease found in PVD patients, including hard and soft plaque, calcium, thrombus, and fibrotic lesions.
“The Jetstream device is a highly effective technology for the treatment of occlusive and thrombotic peripheral arterial disease,” stated Tom Shimshak, MD. “The advances in the cutting tip and increased power in the Jetstream G3 device will be particularly desirable for long, diffusely diseased segments, including calcification, chronic total occlusions, and traditional ‘no-stent' zones.”
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