F Care Systems Launches EVRF to Treat Varicose Veins in the United States

March 21, 2013—F Care Systems USA, LLC (North Miami, FL) announced the launch of its EVRF device to provide endovenous radiofrequency treatment of varicose veins. The EVRF machine has received 510(k) clearance from the US Food and Drug Administration (FDA). F Care, headquartered in Aartselaar, Belgium, previously released the EVRF in the United Kingdom and other countries as Veinwave. With F Care's branch in the United States, the company will be offering full upgrades, training, and support to all current Veinwave and EVRF customers.

In a March 19 announcement, F Care Systems' European headquarters advised that it renewed its FDA registration of the EVRF in the United States, so that the EVRF is now imported under the F Care Systems customs-clearance system. The previous registration, which was held by a nonactive distributor, is therefore no longer valid. As such, all FDA registrations of other products sold under F Care brands like TC 3000 or Veinwave do not have FDA clearance any longer, as they do not come under the quality system of F Care Systems; now, only EVRF has full FDA clearance.

According to the company's press release, the EVRF is designed for treatment of a range of diseased vessels, from spider veins to saphenous veins, using thermocoagulation, which allows the machine to remove the veins by using advanced radiofrequency. A high-frequency signal is generated by the central unit, producing a thermal-like effect, which is then transmitted to the intima of the vein wall with the use of a needle or catheter. As a result of the thermal effect, the vein coagulates without bruising the skin. To treat spider veins, thermocoagulation is performed using a needle. To treat larger veins, a catheter is used. F Care designed the needles and catheters for use only on the EVRF device. The diameter of the needles used for smaller veins range from 0.075 to 0.150 mm, making the tips extremely sharp, which aids in preventing discomfort.

The catheters for larger veins feature high flexibility, rounded tips, and a specially designed handpiece. These catheters can range from 1 to 4 mm in diameter. For efficient removal of the saphena magna, F Care Systems USA extended its product range with a larger catheter that allows a minimally invasive procedure with little to no discomfort and allows the patient to resume normal function within 1 day.