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
Last updated: October 15, 2026
12
min read
By
bioaccess® Team
**Key Takeaways**
- • enVVeno Medical (formerly Hancock Jaffe) conducted FIH in Colombia for their VenoValve bioprosthetic venous valve
- • Published 3-year results: 62% mean reduction in reflux time, 52% in rVCSS, 84% in VAS pain; 3 of 11 patients lost to follow-up after 1 year
- • IDE step: FIH results presented at the January 2021 pre-IDE meeting; IDE for the U.S. SAVVE pivotal study approved March 2021
- • PMA outcome: FDA not-approvable letter August 2025; supervisory appeal denied November 2025
The short answer: enVVeno Medical's VenoValve — the first surgically implanted bioprosthetic venous valve for severe chronic venous insufficiency — has published 3-year first-in-human results from Bogotá, Colombia. That study helped enVVeno reach an FDA IDE for its U.S. pivotal study, but FDA did not approve the PMA, which relied on U.S. pivotal data. Read how early feasibility trials run across Latin America.
What is 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). Severe cases can lead 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.
How did the FIH trial run at Fundación Santa Fe de Bogotá?
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.
enVVeno's 10-K for 2020 says the company ran this small first-in-human study after consultation with FDA, as a precursor to the U.S. pivotal trial, with INVIMA approval in December 2018.
What do the sustained 3-year results show?
The 3-year follow-up results from the Colombia FIH trial are published in Cifuentes et al., Annals of Vascular Surgery (2025). Of 11 patients implanted, 3 were lost to follow-up after 1 year. The paper reports:
| Outcome measure | At 3 years | Source / note |
|---|---|---|
| Reflux time | 62% mean reduction | Cifuentes et al., 2025 |
| rVCSS (revised Venous Clinical Severity Score) | 52% mean reduction (7 points) | Cifuentes et al., 2025 |
| VAS (visual analog scale) pain | 84% mean reduction | Cifuentes et al., 2025 |
| Primary patency | 79% | Cifuentes et al., 2025 |
| Valve thrombosis | 2 patients | Both after anticoagulation was stopped |
**What 3-year FIH data can and cannot do**
The authors note that long-term anticoagulation may be needed to maintain the benefit. First-in-human data like these informed FDA's IDE review for the U.S. pivotal study. They were not the evidence FDA weighed for approval, and FDA did not approve the PMA.
Why was Colombia chosen for regulatory speed?
enVVeno has described the Colombia study as a small first-in-human study run after consultation with FDA and before the U.S. pivotal trial. INVIMA approved it in December 2018.
- INVIMA regulatory approval: December 2018 (enVVeno 10-K, FY2020)
- Implants: 11 patients, February to December 2019, Fundación Santa Fe de Bogotá
- FDA step: FIH results presented at the January 2021 pre-IDE meeting; IDE approved March 2021
- A new medical device clinical trial is led from Panama, El Salvador, Chile, Costa Rica, and the Dominican Republic
What is the SAVVE US pivotal trial?
FDA approved the IDE for the SAVVE U.S. pivotal study in March 2021. SAVVE enrolled at U.S. sites (NCT04943172). enVVeno filed the PMA in November 2024 on the SAVVE data.
What happened to the VenoValve PMA?
FDA did not approve it. enVVeno's 10-K for 2025 says it received a not-approvable letter for the VenoValve in August 2025, and that FDA denied its supervisory appeal on November 13, 2025. The company also says it has elected to forgo approval and commercialization efforts for the VenoValve outside the United States.
The lesson for sponsors: first-in-human data from Latin America can help a program reach an IDE, but approval depends on the pivotal data. See which companies have used Latin American clinical data with FDA.
Where does bioaccess® place a new device trial?
For a medical device clinical trial — first-in-human, early feasibility, or pivotal — bioaccess® leads with Panama, El Salvador, Chile, Costa Rica, and the Dominican Republic. Clinical trials in Colombia are the page for drug, biologic, and vaccine studies. The First-in-Human CRO page is the cross-country device offer.
- A new medical device clinical trial is led from Panama, El Salvador, Chile, Costa Rica, and the Dominican Republic
- Drug, biologic, and vaccine trials are the Colombia recommendation
- The First-in-Human CRO page is the cross-country device offer
- Commercial device registration stays a separate market-authorization service
**Plan a device study in a lead country**
For a medical device clinical trial — first-in-human, early feasibility, or pivotal — bioaccess® leads with Panama, El Salvador, Chile, Costa Rica, and the Dominican Republic. Contact bioaccess® or explore the FIH-12™ program.
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