Biological Adhesive Method in Vein Treatment has been internationally approved by FDA

02/03/2015

Approval has been received after FDA reviewed data of three clinical trials sponsored by the manufacturer of VenaSeal system. This shows that device can be safely and effectively used to treat varicose veins of the legs.

In case of varicose veins patients suffer mild or medium pain, unpleasant feelings of heaviness in legs, swelling of the legs at the end of the day, cramps in shanks of legs etc. Untreated chronic insufficiency of veins can cause irreversible changes in the skin of legs as brownish red patches begin to appear but the most severe expression of chronic insufficiency of veins is a tropic ulcer – damage of the skin and deepest tissues. In these cases therapy includes usage of medicines and compression, as well as surgical methods that take out or seal the damaged veins.

VenaSeal technology is the one offering patient’s innovative option to cure this widespread illness. By announcing this novelty Willam Maisel, MD, PMH, FDA Executive Director of the Device Evaluation Office of the Device and Radiological Health Centre* admitted that biological adhesive method is significantly different from the surgeries where laser, radio waves, steam micro impulses or cuts in the skin are used to eliminate veins. VenaSeal system does not require neither heating nor cutting, this surgery that is can be more likely called a treatment allows patients to return to their everyday life after a short period of time. Under the ultrasound control specialist injects VenaSeal gluing substance – transparent fluid that polymerizes in a solid material.

 

* Megan Brooks, FDA Approves New Varicose Vein Treatment, February 20, 2015


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