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April 8, 2026
FDA Clears InVera Infusion Device to Treat Chronic Venous Disease
KEY TAKEAWAYS
- FDA clears InVera infusion device to treat chronic venous disease, including varicose veins.
- The device is now cleared for use in the United States and European Union.
- Lowell Kabnick, MD, will present 12-month results from the pilot clinical study at the 2026 Charing Cross Vascular Symposium.
April 8, 2026—InVera Medical announced FDA 510(k) clearance for the InVera infusion device for the minimally invasive treatment of diseased leg veins, including varicose veins. The device is now approved for use in the United States and European Union within its indications.
According to the company, the InVera infusion device safely and effectively provides a comfortable, nonthermal, and nonimplant alternative for the treatment of chronic venous disease.
The device features a 5-F catheter with a helical coil to mechanically prepare the vein wall by disrupting the inner media layer for enhanced infusion of sclerotherapy agents. The procedure requires a single injection of local anesthetic, supporting efficiency and faster patient recovery, stated the company.
InVera Medical advised that the 12-month results from the pilot clinical study of the device will be presented April 21 by Lowell Kabnick, MD, at the 2026 Charing Cross Vascular Symposium in London, United Kingdom.
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