enVVeno Medical — VenoValve First-in-Human Study in Colombia → FDA IDE for the U.S. SAVVE Pivotal Study
enVVeno Medical (formerly Hancock Jaffe Laboratories) ran a small first-in-human study of its VenoValve bioprosthetic venous valve in Bogotá, Colombia: 11 patients implanted between February and December 2019 after INVIMA approval in December 2018. Its SEC filings say the results were presented at a January 2021 pre-IDE meeting, and FDA approved the IDE for the U.S. SAVVE pivotal study in March 2021. The PMA, filed in November 2024 on U.S. pivotal data, received an FDA not-approvable letter in August 2025, and FDA denied the supervisory appeal in November 2025.
Study facts
- Sponsor / company: enVVeno Medical
- Indication / area: Vascular Surgery
- Country: Colombia
- Study type: First-in-Human (FIH)
Key metrics
- FIH: Colombia (11 patients)
- FDA step supported: IDE (March 2021)
- PMA outcome: Not approvable (Aug 2025)
- Indication: Severe deep CVI
The challenge
Severe deep chronic venous insufficiency (CVI) has no FDA-approved replacement-valve option. enVVeno's filings say it ran the Colombia first-in-human study after consultation with FDA, as a precursor to a U.S. pivotal trial.
bioaccess® solution
The study was conducted at Fundación Santa Fe de Bogotá under local ethics committee and INVIMA approval. Peer-reviewed 1-, 2- and 3-year follow-up results have been published. Approval of a device depends on its pivotal data, and FDA did not approve the VenoValve PMA.
Results
- 11 patients implanted in Bogotá, Colombia, February–December 2019 (Cifuentes et al., Ann Vasc Surg 2025)
- FIH results presented at the January 2021 FDA pre-IDE meeting (enVVeno 10-K, FY2020)
- FDA approved the IDE for the U.S. SAVVE pivotal study in March 2021
- PMA filed November 2024 on U.S. SAVVE data; FDA not-approvable letter August 2025; supervisory appeal denied November 2025 (enVVeno 10-K, FY2025)
Frequently asked
- What did bioaccess® do for enVVeno Medical?
- The study was conducted at Fundación Santa Fe de Bogotá under local ethics committee and INVIMA approval. Peer-reviewed 1-, 2- and 3-year follow-up results have been published. Approval of a device depends on its pivotal data, and FDA did not approve the VenoValve PMA.
- Where was the enVVeno Medical First-in-Human (FIH) study run?
- The enVVeno Medical First-in-Human (FIH) study was executed in Colombia by bioaccess® in the vascular surgery area.
- What was the outcome of the enVVeno Medical study?
- Reported outcomes for enVVeno Medical's device: 11 patients implanted in Bogotá, Colombia, February–December 2019 (Cifuentes et al., Ann Vasc Surg 2025); FIH results presented at the January 2021 FDA pre-IDE meeting (enVVeno 10-K, FY2020); FDA approved the IDE for the U.S. SAVVE pivotal study in March 2021.
Run a similar trial: Clinical trials in Colombia
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