FDA Clears Atherectomy System With Improved Cutting Tip
January 13, 2010 – The FDA this week granted 510(k) market clearance for the JETSTREAM G3 atherectomy catheter. It features a new distal cutter and enhanced aspiration efficiency over the previous JETSTREAM G2 device.
Pathway Medical Technologies said the G3 offers a significant improvement in cutting and removing disease as compared to previous versions. It is designed for use in removing all types of lesions and blockages in peripheral vessels, including hard and soft plaque, calcium, thrombus, total chronic occlusions, and fibrotic lesions.
“The JETSTREAM device is a highly effective technology for the treatment of occlusive and thrombotic peripheral arterial disease,” said Tom Shimshak, M.D., an interventional cardiologist and director of the cardiovascular laboratory and medical director of the Cardiovascular Institute, Wheaton Franciscan Healthcare, All Saints Medical Center, Racine, Wis. “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.”
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 an expandable cutting tip. Excised tissue and thrombus are continually aspirated through ports 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. Active aspiration is a safety feature that minimizes the risk of distal embolization.
For more information: www.pathwaymedical.com
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