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One-Year First-in-Human Success for VenoValve in Treating Patients With Severe Deep Venous Insufficiency

Jorge H Ulloa1, Marc Glickman2

  • 1Fundacion Santa Fe de Bogota, 27991Universidad de Los Andes, Bogota, Colombia.

Vascular and Endovascular Surgery
|February 7, 2022
PubMed

Insights

The VenoValve shows promising safety and effectiveness for treating severe chronic venous insufficiency (CVI) after one year. This novel device significantly improved patient outcomes, including reduced pain and disease severity.

Area of Science:

  • Vascular Surgery
  • Medical Devices
  • Clinical Outcomes

Background:

  • Chronic venous insufficiency (CVI) stems from venous valve failure, impacting quality of life with limited treatment options.
  • Severe CVI (C5-C6 stages) necessitates advanced therapeutic solutions.
  • The VenoValve is a novel device for treating deep venous CVI.

Purpose of the Study:

  • To evaluate the safety and performance of the VenoValve in a first-in-human (FIH) study.
  • To report 1-year clinical outcomes following VenoValve implantation for severe deep venous CVI.
  • To assess adverse events, reflux, disease severity, pain, and quality of life.

Main Methods:

  • Prospective first-in-human (FIH) study involving 11 patients with C5-C6 CVI.
  • Surgical implantation of the VenoValve into the deep femoral vein.
  • 1-year follow-up assessing safety, reflux time, disease severity (RVCSS), pain (VAS), and quality of life (VEINES-QOL/Sym).

Main Results:

  • Successful VenoValve implantation in all patients.
  • Significant 1-year outcomes: 54% decrease in reflux time, 56% improvement in RVCSS, 76% reduction in VAS pain scores.
  • Adverse events included hematoma, wound infections, and bleeding; one occlusion due to non-compliance with anticoagulation.

Conclusions:

  • The VenoValve demonstrates sustained safety and effectiveness at 1 year post-implantation for severe deep venous CVI.
  • Results support further investigation of the VenoValve as a novel treatment for valvular incompetence.
  • A pivotal US-based multi-center trial (NCT04943172) is underway to further assess safety and effectiveness.
Abstract

Keywords:
VenoValvebioprosthetic porcine valvechronic venous diseasechronic venous insufficiencychronic venous treatmentvalve implantvalvular incompetencyvenous hypertensionvenous valvevenous valve implant

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