QUEENSBURY, N.Y., Nov. 7 -- An endovascular laser venous system (ELVS) has received FDA 510(k) clearance as a treatment for varicose veins, announced its manufacturer, AngioDynamics Inc., a wholly-owned subsidiary of E-Z-EM Inc.
The company's Precision 980nm diode laser and disposable treatment kits received clearance for the specific indication of "endovascular occlusion of leg veins" procedure. The company has also begun its full market release of the ELVS system in the US.
The ELVS treatment is performed on an outpatient basis under local anesthetic. Doctors thread a tiny laser fiber into the saphenous vein to seal it and thereby correct the cause of varicose veins, the company said. The therapy takes less than an hour to perform and the results are often visible immediately.
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