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The latest news on Varithena® Varithena Treatment

Varithena® has been cleared by the FDA for chemical ablation of the saphenous vein. 

 

The VANISH-1 and VANISH-2 studies were phase 3 clinical studies of polidochanol endovenous microfoam undertaken to get "marketing approval from the U.S. FDA.

 

According to the study authors, "VANISH-2 was a randomized blinded multicenter trial to look for improvement of appearance and improvement of symptoms as the primary endpoints of the study".

 

It is not clear at this time (given a lack of head to head comparisons to other ablation technologies) whether the Varithena® procedure is as good, better, or worse than the gold standard techniques such as EVLT® (laser ablation) or VNUS Closure® (radiofrequency ablation).  

 

VANISH-2 states (Phlebology July 17, 2013) that "Duplex [evidence of closure or ablation] as an endpoint adds a furhter limitation in that it is a surrogate endpoint and not a direct measure of patient benefit".

 

This means that the data does not reflect "closure success rates" but is rather safety and efficacy studies as well as studies to look at "symptoms resolution" and "improvement in appearance".

 

Full Prescribing Information" - venous thrombosis limb (8.1%), superficial thrombophlebitis (5.4%), deep vein thrombosis (4.7%). 

 

Unpublished series show that Varithena® is 86 % effective in the short term - compare this to > 95% for EVLT laser ablation or VNUS® radiofrequency ablation - in regards to symptoms or appearance of the legs. 
 
Patients are encouraged to ontact Blue Cross Bluse Shield of Western New York, Univera, Independent Health (IHA), Empire, United Health Care, AETNA, CIGNA, Champus Military, Excellus, Community Blue, Medicaid Services to see if this procedure is covered under their payment policies and guidelines. 
 

On the horizon are other techniques for ablation include foam + Holmium laser (LAFOS®), liquid sclerosant with rotating wire (clarivein®), liquid sclerosant + endo-venous clip (V-Block®) and endovenous cyano-acrylate glue (Venaseal™). None of these procedures are covered by Medicare or traditional insurance in the United States.

 

At the Vein Treatment Center of Buffalo Niagara, we have EVLT Never Touch®, VNUS Closure® and ClariVein®.

We have a Certificate of Completion of Training for Varithena but are waiting to see if it is reimbursed by medical insurance before we recommend it to our patients.
 
If you are interested in the Varithena® procedure for saphenofemoral or saphenopopliteal venous reflux, call Dr. Karamanoukian at the Vein Treatment Center at 716-626-7700 or 716-839-3638.

You should also contact 'customer service' of your insurance carrier to see what codes need to be used and if chemical ablation is covered with Varithena with your particular plan.

 

What is Varithena?

Varithena® (polidocanol injectable foam) is a prescription medicine used to treat varicose veins caused by problems with the great saphenous vein (GSV) and other related veins in the leg's GSV system. Varithena®improves symptoms related to or caused by varicose veins, and the appearance of varicose veins.

Types of Veins Treated

Varithena® treats a wide range of varicose veins in the GSV system, including:

  • Tortuous (twisted) veins
  • Veins above and below the knee
  • Veins with small, medium, and large diameters
  • Veins previously treated with other methods

Varithena® does not treat all forms of varicose veins. Please talk with your doctor to see if Varithena® may be right for you.

How Varithena® works

  • A small amount of Varithena® is administered through a catheter or by direct injection into the malfunctioning vein
  • The Varithena® foam fills and treats the desired section of the vein
  • The diseased vein collapses and the foam is deactivated
  • When the malfunctioning vein collapses, blood flow shifts to healthier veins nearby
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