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FDA welcomes Veinwave UTC to U.S. rollout PDF Print E-mail
The Federal Drug Administration (FDA) has given the United Kingdom developers of Veinwave the clearance to market the product for removal of spider vein and telangiectasia in the United States.

The Federal Drug Administration (FDA) has given the United Kingdom developers of Veinwave the clearance to market the product for removal of spider vein and telangiectasia in the United States.
Having devised the treatment some 10 years ago in conjunction with a group of European doctors, Veinwave was first launched in London in 2001. Endorsed by British vascular surgeon and company spokesman Brian Newman MD, FRCS, spokesmen said Veinwave soon became the gold standard for treating fine spider veins by more than 350 practitioners in the United Kingdom alone.


Adam Rubens, CEO of Sovereign Medical Health in the United Kingdom, said that while lasers and intense light systems were used with some degree of success previously, no treatment has proven to be as safe nor as effective as Veinwave.


“Utilizing the process of Unipolar Thermo-Coagulation (UTC), Veinwave applies a localized heat energy through an ultra fine insulated needle, causing the vein walls to collapse and the vein to disappear instantly,” he said.


“It has a ‘wow’ factor like no other treatment yet it minimizes the risks associated with alternative treatments such as burning, scaring and pigmentation,” Rubens said. “Now, having been preparing the paperwork for submission to the FDA over the past two years, Medical Innovations, in conjunction with Sovereign Medical Health, has received clearance from the FDA to market Veinwave in the United States.”


Already praised by U.S. doctors who have seen the treatment, Veinwave is to be rolled out across the United States beginning in September.


Laurence Newman, managing director of Medical Innovations, said: “Veinwave is the only treatment of its kind utilizing the safe characteristics of thermo-coagulation to have been cleared by the FDA.


“Based upon our experience of eight years working with Veinwave, there is not a condition we haven’t seen nor a question we haven’t heard when talking about vein treatments, and we are bringing that wealth of knowledge and experience to the United States.


“There is no reason why Veinwave cannot be available in every doctor’s office with some interest in dealing with patients wanting their unsightly veins removed — and for those of us who suffer that blight, it can be a real psychological problem for the individual.”


A launch for Veinwave is planned for September and it will then be presented at exhibitions and vascular conferences across the United States in the weeks that follow.


Rubens said that they have already received dozens of enquiries from doctors seeking more information on the treatment.


“We will be presenting Veinwave at workshops from state to state in the next few months,” Rubens said. “Anyone wishing to attend can log in to our website at veinwave.com to find out more information on the treatment and the locations of those meetings.


“We are extremely excited about the prospects of Veinwave here in the United States; particularly now that we have received clearance from the FDA, which gives it the credibility it deserves.”

 
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