FDA Clearance received 60 days from submission and paves way for Commercialization in the United States
KFAR SABA, Israel, June 21, 2023 /PRNewswire/ — VVT Medical, a global medical device company, announces today the receipt of a 510(k) clearance for its ScleroSafe™ platform by the U.S. Food and Drug Administration (FDA).
ScleroSafe™ is a novel medical device specifically created for efficient, Non-Thermal, Non-Tumescent (NT-NT) treatment and management of varicosities in superficial veins. Its unique, inverse-action dual syringe injects a sclerosing substance into the vein through one syringe while simultaneously aspirating blood and substance residuals through the second syringe – all within a single motion and with single-hand operation.
Watch the ScleroSafe™ technology: https://www.youtube.com/watch?v=3ZqSIcWT4Hk&t=62s
ScleroSafe™ has received approval in multiple regions, including Europe, Australia, Southeast Asia, and South America. It has a well-established history of being safe and effective in treating varicosities in superficial veins, benefiting numerous patients globally. Varicose veins, a prevalent condition impacting millions in the United States, often result in considerable discomfort, pain, and potential disability.
According to studies, about 50% of those aged 50 and above are suffering from varicose veins1. This highlights the significant need for effective solutions for the treatment of this condition.
“We take great pride in leading the way in the development of a varicose vein solution. ScleroSafe™ holds the promise of transforming varicose vein treatment, providing patients with a safe, effective, and straightforward option” says Erez Tetro, CEO of VVT Medical. Erez also emphasizes that VVT Medical’s dedicated team is devoted to making ScleroSafe™ available to all patients in need. “We firmly believe that our product has the ability to bring about a positive change in the lives of countless individuals across the United States and worldwide”.
About VVT Medical
VVT Medical is a medical device company, founded with the aim of becoming the new standard of care in vein treatments, by introducing novel solutions for both aesthetic and medical indications. VVT Medical has been dedicated to offering simpler, faster and more efficient minimally invasive non-thermal non-tumescent (NT-NT) procedures, maximizing safety and patient comfort and achieving superior clinical results. The company specializes in the research, development, manufacturing, and commercialization of its products and is dedicated to improving patients’ lives!
Learn more about VVT Medical, at: https://www.vvtmed.com/
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SOURCE VVT Medical