Product
Varisolve® (polidocanol microfoam)
Indication
Varicose veins, venous stasis ulcers
Phase
Phase III (EU); Phase II (US)
Description
Varisolve® is a polidocanol endovenous microfoam product being developed as a first line treatment for incompetent great saphenous veins (GSV) and associated varicosities, above and below the knee.
Further Information
In the United States alone over 40 million patients suffer from varicose veins. Most sufferers opt not to have their veins treated, as current treatments require either the surgical removal of the vein or insertion of a catheter. As potentially the first approved endovenous microfoam, Varisolve® could transform this underserved market by making varicose vein treatment more acceptable.
Varisolve® has a unique controlled density, consistent bubble sizes, and proprietary gas mix that makes it a simple and comprehensive treatment for symptomatic and aesthetic varicose veins. A European Phase III clinical trial showed that 90% of patients treated with Varisolve® had no reflux in the GSV at 3 months and fewer than 10% of patients had recurrence at 1 year.1 Patients can generally return to work or their usual activities the same day they are treated, and cosmetic results after Varisolve® treatment are apparent at 6 weeks.
Varisolve® is in late Phase II development in the US and preparation for US pivotal studies is under way.
1D Wright et al, Varisolve® polidocanol microfoam compared with surgery or sclerotherapy in the management of varicose veins in the presence of trunk vein incompetence: European randomised controlled trial, Phlebology 2006; 21:180-190.
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