enVVeno VenoValve: First-in-Human Trial in Colombia Delivers Sustained 3-Year Results
enVVeno Medical's VenoValve — a bioprosthetic venous valve for chronic venous insufficiency — delivers sustained 3-year results from its first-in-human trial at Fundacion Santa Fe de Bogota, Colombia.
April 10, 2026
12
min read
By
bioaccess® Team
**Key Takeaways**
- • enVVeno Medical (formerly Hancock Jaffe) conducted FIH in Colombia for their VenoValve bioprosthetic venous valve
- • 3-year results: 63% reflux improvement, 64% rVCSS improvement, 83% VAS improvement
- • Zero relapses and zero venous ulcer recurrences across 11 FIH patients
- • Colombia chosen for 18-day ethics approval vs 6 months in EU
- • SAVVE US pivotal trial commenced October 2021
Trial overview: the VenoValve bioprosthetic venous valve
enVVeno Medical (formerly Hancock Jaffe Laboratories) has developed the VenoValve — the first surgically implanted bioprosthetic venous valve designed to treat severe chronic venous insufficiency (CVI). CVI affects an estimated 25–40% of women and 10–20% of men, with severe cases leading to debilitating symptoms including leg ulcers, pain, swelling, and significantly reduced quality of life.
The VenoValve is designed to restore one-way blood flow in the deep venous system by replacing incompetent native venous valves — addressing the root cause of CVI rather than merely managing symptoms.
FIH trial at Fundacion Santa Fe de Bogota
The first-in-human trial for the VenoValve was conducted at Fundacion Santa Fe de Bogota, one of Colombia's most prestigious medical institutions. The study enrolled 11 patients under the direction of Principal Investigator Dr. Jorge Ulloa, a leading vascular surgeon.
The choice of Colombia — and specifically Fundacion Santa Fe — was strategic. The institution's reputation for clinical excellence, combined with Colombia's efficient regulatory process, provided the ideal environment for generating high-quality first-in-human clinical data.
Sustained 3-year results presented at American Venous Forum
The 3-year follow-up results from the Colombia FIH trial were presented at the American Venous Forum (AVF) 2023, demonstrating sustained clinical benefit across all key endpoints:
| Outcome Measure | 3-Year Improvement | Clinical Significance |
|---|---|---|
| Venous reflux | 63% improvement | Restoration of one-way blood flow |
| rVCSS (Revised Venous Clinical Severity Score) | 64% improvement | Overall symptom reduction |
| VAS (Visual Analog Scale) | 83% improvement | Patient-reported pain reduction |
| Venous ulcer recurrence | 0% | No ulcer relapses in follow-up |
| Overall relapse rate | 0% | Sustained efficacy through 3 years |
**Why 3-year sustained results matter**
For implantable devices treating chronic conditions, long-term durability is the ultimate measure of success. The VenoValve's zero-relapse rate and sustained improvements across all clinical endpoints through 3 years provide compelling evidence that the device delivers durable clinical benefit — exactly the data profile needed to support a US pivotal trial.
Colombia chosen for regulatory speed: 18 days vs 6 months
One of the most striking aspects of the enVVeno story is the specific reason Colombia was chosen: ethics committee approval was obtained in just 18 days, compared to an estimated 6 months in the European Union. This 10× faster approval timeline allowed enVVeno to begin generating clinical data months ahead of schedule.
- Ethics committee approval: 18 days in Colombia vs ~6 months in EU
- INVIMA regulatory pathway: efficient and well-established for medical devices
- Fundacion Santa Fe de Bogota: world-class vascular surgery capabilities
- Dr. Jorge Ulloa: experienced PI with international reputation
- FDA acceptance: Colombia FIH data accepted as foundation for US pivotal trial
SAVVE US pivotal trial
Building on the compelling 3-year FIH data from Colombia, enVVeno launched the SAVVE US pivotal trial in October 2021. The SAVVE trial is designed to generate the definitive clinical evidence needed for FDA approval of the VenoValve for commercial use in the United States.
The progression from Colombia FIH to US pivotal trial exemplifies the development pathway that bioaccess® advocates: use Latin America to generate initial safety and efficacy data, then leverage those results to design and de-risk larger US studies.
bioaccess® and first-in-human trials in Colombia
The enVVeno VenoValve story is a textbook case study in using Colombia for first-in-human medical device trials. bioaccess® has deep expertise in conducting clinical trials in Colombia, including regulatory submissions, site selection, and full clinical operations.
- INVIMA regulatory strategy and clinical trial submissions
- Site selection across Colombia's leading medical institutions
- Ethics committee management (18-day typical approval)
- Full clinical operations: monitoring, data management, safety reporting
- Post-trial market access via bioaccess® MARKET ACCESS ACCELERATOR™
**Ready to launch your FIH trial in Colombia?**
Join enVVeno and 50+ other medtech companies who have used Latin America for faster first-in-human studies. Contact bioaccess® today or explore our FIH FastTrack program.
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