The practice of sclerotherapy with foam for the treatment of varicose veins started over 20 years ago. Currently, most professionals that employ this technique use the method described by Tessari for foam preparation. There had been very few solutions which improved this method until VB Devices, after more than 7 years of development, created the first device for automated and standardised foam preparation.
In the late 1990s, the fantastic results from treatment with foam sclerotherapy of truncal varicose veins and vascular malformations published by the Doctors Cabrera changed the perception of a technique limited to complementary treatment. This great advance based on the incorporation of physiological gases (combination of O2/CO2) and the generation of a homogeneous foam contrasted with the difficulty of obtaining such results with conventional methods.
To Lorenzo Tessari we owe the popularisation of a simple, low-cost method, albeit with some limitations regarding the use of certain sclerosant concentrations and gases more soluble than ambient air.
The opportunity to make a standardised multipurpose foam accessible to a greater number of professionals was the main motivation that prompted us to create the first automated system for microfoam preparation – VARIXIO.
We began the project with a sterile pot, to which we added a mixing element made from a modified magnet. Using laboratory stirrers/mixers as a starting point, we experimented with different magnets and stirring parameters until we were able to consistently generate high-quality foams in sterile conditions.
In 2013 and 2014, we confirmed the viability of microfoam preparation from ambient air as well as a mixture of gases based on combinations of O2 and CO2.In June 2014, at the European Venous Forum conference in Paris, we presented the results of a comparative study between foam prepared using the Tessari method and foam prepared using the new stirring system. This study demonstrated clear differences in the physical characteristics of the foams produced.
The firm conviction that an automated standardised foam-production system could represent a great advance in sclerotherapy drove us to start developing VARIXIO, building on the work already done.
With the support of local investors and under the direction of Federico Grego, in 2016 the start-up Vascular Barcelona Devices, S.L. (VB Devices) was created, which over the next 5 years developed VARIXIO with the support of the Centro de Desarrollo Tecnológico EURECAT, the lnstitut de Química Avançada (IQAC/CSIC), and INNOVAMED, all in Barcelona, Spain. We have had to overcome many technological difficulties, but despite the challenges, we achieved our goal, culminating in the certification as a medical device obtained in October 2020.
VARIXIO is a highly-versatile device that allows preparation of a standardised, high-quality microfoam with the most commonly-used sclerosing agents (polidocanol and STS), both with air and physiological gases, even at concentrations at which the Tessari method does not.