Setting New
Standards for
Venous Care
Setting New
Standards for
Venous Care
What is Chronic Venous Insufficiency (CVI)?
Insufficient blood is returned to the heart and lungs due to damaged valves in the veins of the leg.
First-in-class surgical replacement venous valve for treatment of Chronic Venous Insufficiency (CVI) in the deep veins of the leg.
Patient Experience From Pivotal SAVVE® Trial
Initial Positive Efficacy Data From SAVVE Trial
11-Month Topline Revised Venous Clinical Severity Score (rVCSS) Improvement*
• Overall 8.46 Average Revised Venous Clinical Severity Score (rVCSS) Improvement Per Patient for Patients Showing Clinical Meaningful Benefit (rVCSS Improvement ≥ 3 Points) including:
• 9.29 Points for Patients at the Two-Year Milestone
• 8.08 Points for Patients at the One-Year Milestone
• 8.71 Points for Patients at the Six-Month Milestone
• 72% of the Study Patients Showing Clinical Meaningful Benefit from the VenoValve at a Weighted Average of 11 Months Post Surgery
• 94% of VenoValve Study Patients Showing Clinical Improvement at a Weighted Average of Eleven Months Post Surgery (rVCSS Improvement ≥ 1 point)
* Data compared to baseline
Preliminary 11 Month Efficacy Data
Preliminary 11 Month Efficacy Data
Clinical Meaningful Benefit Cohorts
Clinical Meaningful Benefit Cohorts
Clinical Meaningful Benefit Cohorts
Clinical Meaningful Benefit Cohorts
rVCSS Cohorts Subanalyses
rVCSS Cohorts Subanalyses
12 Month Ulcer Healing Data Showing Significant Improvement
• 91% of Venous Ulcer Patients Evaluated at One Year Have Either Fully Healed Ulcers or Ulcers That Have Improved
• 100% of Venous Ulcers with a Duration of One Year or Less Prior to VenoValve Surgery Have Fully Healed
• 89% of Venous Ulcers with a Duration of More Than One Year Priot to VenoValve Surgery have Fully Healed or Improved
• No Ulcer Recurrences
Venous Ulcer Healing
