FDA Product Code MCW: Catheter, Peripheral, Atherectomy

Peripheral artery disease caused by atherosclerotic plaque can be treated by directly removing the obstruction. FDA product code MCW covers peripheral atherectomy catheters.

These devices use rotating blades, laser energy, or orbital abrasion to debulk atherosclerotic plaque from peripheral arteries, restoring blood flow without the vessel stretching associated with balloon angioplasty. They are used in the treatment of femoral, popliteal, and tibial artery disease.

MCW devices are Class II medical devices, regulated under 21 CFR 870.4875 and reviewed by the FDA Cardiovascular panel.

Leading manufacturers include Cardiovascular Systems, Inc., Pathway Medical Technologies, Inc. and Avinger, Inc..