New Varicose Vein Treatment Approved by FDA

A new varicose vein treatment called the VenaSeal™ closure system was approved by the Food and Drug Administration in February, 2015.

“This new system is the first to permanently treat varicose veins by sealing them with an adhesive, thereby giving patients another treatment option for this common condition,” said William Maisel, M.D., M.P.H., acting director of the Office of Device Evaluation in the FDA’s Center for Devices and Radiological Health.

This Article

  • Improved My Health
  • Changed My Life
  • Saved My Life

The VenaSeal™ system can be used as an in-office procedure. It does not use heat nor does it require incisions, so the patient should be able to return to regular activities with less bruising, he added.

Varicose veins fall into two groups: deep veins and superficial veins. Usually varicose veins do not cause people health problems but in some cases they can cause pain, blood clots, skin ulcers, or other difficulties according to the National Heart, Lung, and Blood Institute at the National Institutes of Health.

Only people who need treatment for superficial varicose veins are candidates for the VenaSeal™ system.

The VenaSeal™ system works by having the doctor insert a tiny catheter into the unhealthy vein through a small puncture in the skin. Ultrasound is used to locate the precise placement for the catheter tip.

Then a small amount of adhesive (a medically approved type of cyanoacrylate) is injected through the catheter using a special gun-shaped dispenser to close off the varicose vein.

Blood that is returning to the heart then travels via other surrounding veins and the body, through the normal healing process, and absorbs the glued vein.

The VenaSeal™ system has shown itself to be safe and effective, with consistent results from three clinical trials.

The system has approval in the United States, Australia, Canada, Europe and Hong Kong. So far, more than 2,000 patients have been treated with the VenaSeal™ system. Documented closure rates from various treatment groups have been over 92 percent, reported NASDAQ.com.

The cost for treatment with the VenaSeal™ system is not currently known here in the United States. However, The VeinCare Centre in the U.K. says that since the system is so new the cost will be higher than other practiced treatment methods. Currently it is not covered by insurance.

The VenaSeal™ system should not be used for those who have a known hypersensitivity to the VenaSeal™ adhesive, or who have inflammation of the veins due to blood clots and if they have other total body infections.

This Article

  • Improved My Health
  • Changed My Life
  • Saved My Life

Adverse side events to the VenaSeal™ system include vein inflammation( phlebitis), and burning or tingling in the treatment area. However, these types of side effects are also common when using other treatments for varicose veins.

The VenaSeal™ system was previously developed by Sapheon Inc., but the company was purchased by Covidien in 2014. Covidien was recently purchased by Medtronic in January, 2015.

Covidien (Medtronic) is also the manufacturer of another varicose vein treatment product called Venefit™, which uses heat. People should discuss with their doctors which type of varicose vein treatment is more appropriate for them.

Sources:

FDA News Release. FDA approves closure system to permanently treat varicose veins. Retrieved March 29, 2015.
http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm435082.htm and
http://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/DeviceApp...

Medtronic's VenaSeal Wins FDA Nod for Vericose Veins Cure - Analyst Blog. . Retrieved March 29, 2015.
http://www.nasdaq.com/article/medtronics-venaseal-wins-fda-nod-for-veric...

What Are Varicose Veins? National Heart, Lung, and Blood Institute at the National Institutes of Health. Retrieved March 29, 2015.
http://www.nhlbi.nih.gov/health/health-topics/topics/vv

Treatment Sapheon VenaSeal. The VeinCare Centre. Retrieved March 29, 2015. Retrieved March 29, 2015.
http://theveincarecentre.co.uk/treatment-sapheon-venaseal.php

Michele is an R.N. freelance writer with a special interest in woman’s healthcare and quality of care issues.

Edited by Jody Smith