EnVVeno Medical Unveils One-Year VenoValve Trial Results

enVVeno Medical Corporation presented the one-year data from its VenoValve U.S. pivotal trial at the 51st VEITH Symposium. The data underlines an 85% clinical meaningful benefit responder rate, with participants showing an average 7.91 point improvement in the revised Venous Clinical Severity Score (rVCSS).

The trial also highlighted a 97% target vein patency rate, with pain broadly reduced by 75%. Moreover, an 87% median reduction in ulcer area was observed among participants with venous ulcers. Robert Berman, CEO, noted the potential of VenoValve as an option for severe deep venous CVI treatment.

Further safety information was detailed, noting one unrelated death and other adverse events with no long-term negative impact reported. The findings are expected to support enVVeno's pre-market authorization application with the FDA.