FDA Grants 510(k) Clearance to VVT Medical's ScleroSafe System
VVT Medical, a global medical device company, has announced the FDA's clearance of its ScleroSafe™ platform. The ScleroSafe™ system is a novel medical device designed for the efficient treatment and management of varicosities in superficial veins using a Non-Thermal, Non-Tumescent (NT-NT) approach. It features a unique dual syringe system that injects a sclerosing substance into the vein while simultaneously aspirating blood and residual substances, all in a single motion and with one-hand operation.
The ScleroSafe™ system has already obtained regulatory approval in various regions, including Europe, Australia, Southeast Asia, and South America. It has demonstrated a proven track record of safety and effectiveness in treating varicosities in superficial veins, benefiting numerous patients worldwide. Varicose veins affect a significant number of people in the United States, causing discomfort, pain, and potential disability.
The prevalence of varicose veins is particularly high among individuals aged 50 and above, with studies indicating that about 50% of this population group experience this condition. This highlights the urgent need for effective treatment solutions. The FDA's clearance of the ScleroSafe™ system represents a major step forward in addressing this need and offers hope for improved outcomes and enhanced quality of life for individuals dealing with varicose veins.