FDA Approves New Treatment for Varicose Veins

Written by on April 1, 2015 in Research & Technology - No comments

In a decision that will provide a new, permanent treatment option for symptomatic varicose veins, the US Food and Drug Administration (FDA) approved the VenaSeal closure system.  The VenaSeal system delivers a specially formulated adhesive via catheter through the skin to the diseased vein to seal it. This is an in-office procedure which allows patients to quickly return to their usual activities, with less bruising.

LabStuffWEBCosmetics aside, varicose veins and their complications can be disabling. Patients report leg heaviness and aching, throbbing pain, muscle cramps, leg swelling, and in severe cases, painful skin ulcers near the ankles. Blood clots can also result from chronic venous insufficiency (CVI). Although ulcers only affect up to 1% of the population, the less severe manifestations are prevalent in 2-56% of the population worldwide. CVI is one of the most commonly reported medical conditions in the United States, and associated venous ulcers account for greater than US$ 1 billion annually in healthcare costs.

Treatment of varicose veins traditionally include lifestyle changes such as avoiding tight clothes, high heels, increase in physical activity and weight loss, and avoiding standing for prolonged periods of time. Compression stockings keep blood from pooling and reduce swelling.

Procedures used to treat symptomatic varicose veins include:

  • Sclerotherapy: A chemical is injected into the vein, causing irritation and scarring inside the vein, which then closes off and fades away. Often used to treat spider veins, and smaller varicose veins.
  • Laser Surgery: Laser energy is directed to the vein, which fades away. Also used to treat smaller varicose veins.
  • Endovenous Ablation Therapy: This treatment uses heat via a catheter to close off the vein. Usually patient can go home the same day.
  • Endoscopic Vein Surgery: In this procedure, the physician makes a small cut in the skin near the varicose vein,  and inserts a tiny camera at the end of a catheter that moves through the vein. A surgical device attached to the camera closes the vein. This procedure is usually only used in severe cases where ulceration is present. Recovery time is several weeks.
  • Ambulatory Phlebectomy: A same-day procedure to remove superficial varicose veins.
  • Vein Stripping and Ligation: Involves tying shut and removing veins through small cuts in the skin. Done only for severe varicose veins. Recovery time is about 1 to 4 weeks.

The more invasive procedures have a longer recovery period than that of the VenaSeal system. The VenaSeal system is intended for patients with symptomatic, superficial varicose veins. Clinical data reviewed by the FDA in a premarket approval application shows the device to be safe and effective for vein closure in varicose vein treatment. Adverse effects included vein inflammation (phlebitis) and tingling (paresthesia) in the treatment area. Contraindications to the use of the VenaSeal system are acute sepsis, acute thrombophlebitis, and hypersensitivity to the VenaSeal adhesive, n-butyl-2-cyanoacrylate.



By Alexis Gopal MD:
Gopal Medical Communications

About Alexis Gopal MD:
Gopal Medical Communications is owned and operated by Alexis Gopal, MD, a physician and medical writer with years of clinical experience in Internal Medicine and medical education. Dr. Gopal is a member of the American Medical Writer’s Association, and specializes in writing medical news, clinical research abstracts, posters, website and marketing content, and education materials in a diverse array of specialties. Engaged in researching, writing, and editing publications for healthcare professionals and lay audiences. Well versed in critically evaluating, analyzing, and interpreting the medical literature in a wide range of therapeutic areas. Dr. Gopal is especially gifted in translating complex medical information into layperson’s language. She has been published in The American Journal of Emergency Medicine, Medmonthly.com and Yahoo.com. She can be reached at info@gopalmedicalcommunications.com.

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