Foam treatment of varicose veins easier thanks to new approach
Foam sclerotherapy is sometimes called the ‘gold standard’ for treating varicose veins non-invasively. Guided by ultrasound imaging, the medical procedure involves injecting a chemical agent, as a liquid or foam, into varicose blood vessels so they will safely close, shrink and dissolve. “Foam sclerotherapy for varicose veins has boomed in recent years, but the foam is still prepared manually, posing significant challenges for practitioners,” says Federico Grego, project coordinator of the EU-funded VARIXIO project. Foam prepared manually can be low in quality, lack consistency and stability, or just be unsuitable for treating smaller veins.
A micro-foam mixed automatically
In 2016, Barcelona-based vascular surgeon Enric Roche patented an approach for automating the foam preparation process. This resulted in a portable device called VARIXIO, developed by the Spanish start-up VB Devices, of which Grego and Roche are co-founders. “VARIXIO can successfully address foam sclerotherapy’s main weaknesses, which currently limit its use to mainly larger varicose veins. Physicians will now be able to prepare very high-quality foam in an automated and consistent way, opening the door to surgery-free treatment of varicose veins of every type,” explains Grego. Tiny spider veins, affecting more than 80 % of adults, will now be treatable with foam sclerotherapy too. This breakthrough stems from VARIXIO’s ability to produce foam using very low concentrations of sclerosant – the shrinking agent. For big varicose veins, where large amounts of foam must be injected, the device simplifies the foam preparation process, even when using physiological gases like carbon dioxide – sometimes required for safety reasons in certain patients. Project developers faced several technical challenges, such as extracting the foam from the mixing capsule, eliminating the formation of large bubbles, and ensuring no particles were present in the newly prepared foam. “Our solutions included adaptations to the product design or manufacturing process, many of which were incorporated into the third patent we filed for the VARIXIO device,” adds the coordinator.
Extensively tested
Physical and chemical testing of VARIXIO were done together with the Institute for Advanced Chemistry of Catalonia in Barcelona, optimising the foam preparation parameters for any combination of gas type, sclerosant type and sclerosant concentration. Development also included usability testing with physicians in Spain, to enhance product design and user experience. The new device is planned to go on sale in Spain in January 2021, followed by other countries worldwide. VB Devices is preparing for e-commerce and is also talking with distributors. The goal is to sell over 1 million units of VARIXIO by 2026, with sales approaching EUR 50 million. “VARIXIO could revolutionise foam sclerotherapy worldwide, increasing the quality and versatility of this procedure, and all but eliminating the need for surgery when treating varicose veins,” Grego says. “Patients will undergo a safe, effective and minimally invasive procedure whatever type of varicose veins they have, and often benefit from fewer treatment sessions,” Roche adds. “Physicians and their staff can look forward to standardised, high-quality foam, with added stability, convenient automation and the versatility to treat any type of varicose veins with foam sclerotherapy.”
Keywords
VARIXIO, automation, device, foam sclerotherapy, gases, preparation, sclerosant, spider veins, treatment, varicose veins