Researchers in Colombia behind the first-in-human study of a novel bioprosthetic venous valve designed to treat chronic venous insufficiency (CVI) reported three-year results among eight patients during the 2023 annual meeting of the American Venous Forum (Feb. 22–25) in San Antonio, Texas, providing attendees with updated data on improvements in venous reflux of 63%, revised venous clinical severity score (rVCSS) of 64%, and visual analog scale (VAS) of 83% compared to pre-surgery levels.
The VenoValve device has been developed to be surgically implanted in the femoral vein of patients with C5–C6 disease on the CEAP (Clinical-Etiological-Anatomical-Pathophysiological) classification.
Presenter Jorge Ulloa, MD, from Fundacion Santa Fe-Universidad de los Andes, Bogota, Colombia, principal investigator of the first-in-human trial, said the findings demonstrated the VenoValve “appears to be safe with continued significant benefit.”
The two-year findings, presented at the 2021 Vascular Annual Meeting (VAM) in San Diego, showed 63% improvement in venous reflux time, 60% improvement in VCSS score, and a 93% improvement in recorded pain, or VAS, when compared with preoperative levels.
At AVF 2023 in San Antonio, Ulloa said the eight patients showed “continued and stable improvement” for three years, with no ipsilateral ulcer recurrence. “It appears that long-term anticoagulation may be necessary,” he added.
The VenoValve is currently undergoing clinical trial in the U.S. in the SAVVE study, or Surgical anti-reflux venous valve endoprosthesis.