InterVene — First-in-Human Autologous Venous Valve Reconstruction
InterVene developed the BlueLeaf Endovenous Valve Formation (EVF) System, a novel approach to reconstruct venous valves using the patient's own tissue, offering a potential cure for chronic venous insufficiency. The BlueLeaf EVF System received FDA Breakthrough Device Designation in 2021. bioaccess® managed the first-in-human trials in Latin America.
Study facts
- Sponsor / company: InterVene
- Indication / area: Vascular Surgery
- Country: Colombia
- Study type: First-in-Human (FIH)
Key metrics
- Trial Type: FIH
- Approach: Autologous
- Indication: CVI
- Outcome: Valve competency
The challenge
Chronic venous insufficiency affects over 40 million Americans with no definitive cure. InterVene's autologous approach needed first-in-human validation to prove that reconstructed venous valves could restore competent venous flow, but US surgical trial costs and timelines were prohibitive.
bioaccess® solution
bioaccess® identified vascular surgery centers in Colombia with expertise in venous reconstruction, managed regulatory and ethics approvals, coordinated surgical procedures, and oversaw duplex ultrasound and clinical outcome follow-up aligned with FDA expectations.
Results
- FDA Breakthrough Device Designation granted (2021) for the BlueLeaf EVF System
- First-in-human venous valve reconstructions performed successfully
- Duplex ultrasound confirmed restored valve competency
- Clinical symptom improvement documented at follow-up
- Safety and feasibility data generated for FDA submission planning
- Study completed within budget using LATAM cost efficiencies
Frequently asked
- What did bioaccess® do for InterVene?
- bioaccess® identified vascular surgery centers in Colombia with expertise in venous reconstruction, managed regulatory and ethics approvals, coordinated surgical procedures, and oversaw duplex ultrasound and clinical outcome follow-up aligned with FDA expectations.
- Where was the InterVene First-in-Human (FIH) study run?
- The InterVene First-in-Human (FIH) study was executed in Colombia by bioaccess® in the vascular surgery area.
- What was the outcome of the InterVene study?
- Reported outcomes for InterVene's device: FDA Breakthrough Device Designation granted (2021) for the BlueLeaf EVF System; First-in-human venous valve reconstructions performed successfully; Duplex ultrasound confirmed restored valve competency.
Run a similar trial: Clinical trials in Colombia
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