ClariVein (R) Catheter for varicose veins, the final results of clinical trials announced

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Vascular Insights has received 510 (k) approval from the Food and Drug Administration (FDA) for infusion ClariVein market certain medical agents in the peripheral vasculature. The company holds certification from BSI (British Standards Institution) that the design, development, production and distribution of ClariVein device complies with the requirements of ISO 13485: 2003.Thirty patients with a mean age of 55 were included in this first trial in humans. Most patients had symptomatic varicose veins with venous disease had advanced as swelling and skin changes. The average diameter was 8.1 mm vein. The treatment of each vein averages 5 minutes and the general procedure time was 14 minutes.

Six-month follow-up, 29 of 30 treated veins were closed properly. Vena just did not react was that of the first patient. After the process, to date 22 other patients underwent the procedure ClariVein, with all the success to be.

The initial results of clinical trials ClariVein catheter used in a new minimally invasive treatment of varicose veins, have been announced. It combines mechanical and chemical methods for treatment in a vein in office.

Steve Elias MD FACS FACPh, is an associate professor of surgery at Mount Sinai Hospital in New York and the director of the Centers for Disease vein at Mount Sinai Hospital and Englewood.

The catheter is a product of ClariVein Vascular Insights LLC of Madison, CT. The company engages in the design, development, production and marketing of medical devices for minimally invasive treatment.

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