Figures cited from published bioaccess® pages and named Hancock Jaffe / enVVeno and MassDevice coverage, verified 23 August 2026. General information, not legal or regulatory advice. Confirm current INVIMA and FDA rules with qualified advisers. We name only the hospital, PI, and trial those sources support.
If you searched Fundación Santa Fe de Bogotá clinical trial, FSFB first-in-human, VenoValve Bogotá, or “go direct to Santa Fe,” you are following a hospital name that is genuinely in the public file. Fundación Santa Fe de Bogotá is a real first-in-human site in Colombia. It is not the operator of the INVIMA file.
bioaccess®’s position is simple and it is not adversarial: FSFB is the site. The First-in-Human CRO still owns INVIMA, investigational import, insurance, ISO 14155 monitoring, and the FDA 21 CFR 812.28 package — plus the option to add Panama or another Latin American country if Bogotá is not the only fit. Sponsors who skip the CRO and email the hospital still have to rebuild that stack. The hospital does not become a CRO because a 2018 press release named it.
This page is the intercept for that search. It does not clone CRO in Colombia or the results essay enVVeno VenoValve first-in-human trial, Colombia. Those pages stay the country system and the program narrative. This page answers the site-named query.
Why the hospital name wins the search — and why that is not a CRO
Device press writes the implant, the city, the hospital, and the committee. It rarely writes the CRO. The VenoValve first-in-human is the clean public example for Bogotá.
On 9 August 2018, Hancock Jaffe Laboratories (now enVVeno Medical) announced Medical Research Committee approval at Fundación Santa Fe de Bogotá (FSFB) for first-in-human testing of the VenoValve® bioprosthetic venous valve, after prior FSFB Ethics Committee approval. The same release is explicit about the next national step: the company would gather information to apply to INVIMA (Instituto Nacional de Vigilancia de Medicamentos y Alimentos), “the Colombian equivalent of the U.S. Food and Drug Administration,” because INVIMA approval is required to import investigational medical devices and conduct human clinical trials in Colombia. Live source: enVVeno / Hancock Jaffe, 9 August 2018. MassDevice reported the same FSFB committee sequence the same week.
That sentence is the whole intercept. The hospital committee can say yes. The national import and trial permit is still INVIMA. A site MSA does not replace it.
Later public follow-up names the investigator. Venous News coverage of two-year data at SVS VAM 2021 identifies Jorge Ulloa (Fundación Santa Fe–Universidad de los Andes, Bogotá) as PI. The live bioaccess® results page states the same PI, an 11-patient FIH at FSFB, and 3-year AVF 2023 outcomes: 63% reflux, 64% rVCSS, 83% VAS, zero relapses and zero venous-ulcer recurrences. Ethics on that page: 18 days in Colombia versus an estimated six months in the EU. SAVVE, the U.S. pivotal, is described as commencing October 2021.
The 2018 sponsor releases do not name a CRO. That is how a sponsor finds FSFB without finding the operator. bioaccess®’s VenoValve results page lists FSFB in its Colombia site-selection set, plus INVIMA submissions and full clinical operations. We will not invent a sentence the 2018 copy does not contain. For a new device FIH at this hospital, hire the CRO that still runs Colombia files.
FSFB is a site. The CRO is the operator.
A Bogotá university hospital can provide operating rooms, vascular imaging, and an investigator who has already taken a bioprosthetic venous valve through first-in-human follow-up. That is necessary. It is not sufficient for a first-in-human device study a U.S. board expects to survive FDA review.
What a site can typically do when a sponsor “goes direct”:
- Discuss investigator interest and surgical feasibility with a PI such as Dr. Jorge Ulloa’s service — when that service is available and appropriate for your device, which is not automatic.
- Share institutional ethics-committee calendars and hospital research rules (the same FSFB Ethics Committee / Medical Research Committee pair Hancock Jaffe cited).
- Quote procedure, bed, and local staffing costs for the cases they will physically run.
What the site is not built to own for an investigational device:
- INVIMA. Hancock Jaffe’s own 2018 language already separated FSFB committee approval from the national permit and import. That split has not gone away.
- Investigational import. Ethics letter plus investigator’s brochure plus an importation permit — end-to-end work, not a PI email.
- Clinical trial insurance. Required. Ask for a protocol-specific premium; we will not invent a Santa Fe-only number here.
- ISO 14155 monitoring, EDC, SAE reporting, and the TMF. The hospital runs the case. The CRO runs the quality system the FDA will later ask about.
- The 21 CFR 812.28 package. Foreign data is eligible for FDA submission and review after GCP / ethics documentation as that rule defines it. Eligibility is not clearance, and a site MSA does not produce it.
- Multi-site and multi-country optionality. bioaccess® publishes 20+ pre-qualified Colombian sites in Bogotá, Cali, Medellín, and Barranquilla. If FSFB is not the right room — or if the indication later needs Panama — a single-hospital MSA will not stretch.
Going direct to Fundación Santa Fe is how you confirm a room and a surgeon. It is not how you open a first-in-human investigation.
How INVIMA actually works (the short version a hospital search needs)
Use CRO in Colombia for the operating line. The facts a sponsor searching this hospital needs on one screen:
INVIMA issues the clinical-trial permit for investigations. Ethics review sits with the site’s comité de ética. Those are two clocks. Hancock Jaffe’s 2018 release is a public walkthrough of that split: FSFB ethics, then FSFB medical-research committee, then INVIMA for import and the human trial.
Published bioaccess® facts we will not average into a new median:
- On the VenoValve results page: ethics committee approval in 18 days for that Colombia FIH, versus ~6 months estimated in the EU.
- On clinical-trials-panama’s Colombia comparison: Colombia ethics 4–6 weeks; per-patient $15,000–$25,000 (versus Panama 3–5 weeks and $12,000–$22,000).
- On CRO in Colombia: 30+ historical FIH device studies; 20+ pre-qualified sites; INVIMA as a PAHO/WHO Level 4 authority; Miami HQ; local Colombian entity and office.
Ask for a protocol-specific calendar. Do not treat a hospital hallway estimate as INVIMA clearance. bioaccess® manages the submission and keeps the reviewer relationship in-country; that is CRO work, not site work.
All bioaccess® Colombia protocols are designed under ISO 14155 and informed consent / ethics requirements so the dataset can be discussed with FDA under 21 CFR 812.28 on a case-by-case basis — not a guarantee of clearance or approval.
What the VenoValve public file actually supports — and what it does not
We will stay inside sourced sentences.
- Device: VenoValve, a porcine / bioprosthetic venous valve intended for surgical implant in the deep venous system for severe chronic venous insufficiency (Hancock Jaffe 2018; bioaccess® results page).
- Site: Fundación Santa Fe de Bogotá, Bogotá, Colombia.
- PI: Dr. Jorge Ulloa (bioaccess® results page; Venous News / SVS VAM 2021 follow-up).
- FIH size on the bioaccess® page: 11 patients.
- 3-year numbers on that page: 63% reflux, 64% rVCSS, 83% VAS; 0% ulcer recurrence; 0% overall relapse as published there.
- U.S. next step on that page: SAVVE pivotal commenced October 2021.
- Not claimed here: that the 2018 release named bioaccess®, or that FSFB is the only Colombian site we use.
What the CRO still does after you have a hospital name
Once FSFB is on the slide, the remaining job is the one sponsors skip when they go site-direct:
- Regulatory-fit, not tourism. Colombia is still a jurisdiction we execute in. It is not automatically the right country for every indication. Country choice is a review, not a 2018 clipping.
- Protocol, IB, ICF, insurance, and the INVIMA packet.
- Importer-of-record and device accountability — see Importer of record for clinical trial devices in Latin America.
- Site activation that is more than a tour: contracts, training, investigational product, EDC, monitoring plan — at FSFB if it is the right site, or at another pre-qualified Colombian hospital if it is not.
- ISO 14155 monitoring and the 21 CFR 812.28 narrative for a later Pre-Sub, IDE, 510(k), De Novo, PMA, or HDE — eligibility, not a promise of FDA action. See Can OUS first-in-human data support an FDA IDE submission?.
- A 12-month protocol-to-LPLV written guarantee on the FIH-12™ model published on our country and comparison pages — not a hospital “we can start next month” hallway number.
Do not smear the hospital — and do not confuse commercial “first in LATAM” with FIH
Fundación Santa Fe de Bogotá is a serious institution. This page is not a critique of FSFB. It is a correction of the vendor model. Use the hospital. Hire the operator.
A different Bogotá brand will also appear in “first in Latin America” results: LaCardio / Fundación Cardioinfantil (Aurora™ EV-ICD, Dr. William Bautista). That is a commercial first implant, not FIH, and not an FSFB claim.
We will not invent FSFB as the site for PAVmed, ReGelTec, Avantec, Watershed, Mitralign, OcuMedex, or PercAssist. See the hub: LATAM FIH hospitals vs the CRO.
Colombia is still on the map
A Santa Fe or Panama Clinic search sometimes arrives with a stale story that bioaccess® left Colombia. That is false. bioaccess® still runs clinical trials in Colombia (Julio Martinez-Clark, CEO, 23 August 2026). Always bioaccess®. INVIMA clocks are managed in-country through the local entity, not watched from a Miami-only docket. The founder podcast, when a conversation needs a voice, is Global Trial Accelerators™.
Site versus CRO
| Workstream | FSFB / the site | bioaccess® / the CRO |
|---|---|---|
| Procedure | Vascular OR, imaging, local staff, PI service | Protocol fit, training, device accountability |
| Ethics / research committee | Institutional review (the 2018 FSFB pair) | Packet, ICF, IB, deficiency responses |
| National authority | Not the permit holder by being named in press | INVIMA clinical-trial permit and correspondence |
| Import | Receiving and storage if contracted | Importer of record — Hancock Jaffe already said INVIMA is required to import |
| Quality / FDA | Source documents from the cases | ISO 14155 + 21 CFR 812.28 narrative |
Frequently asked questions
Can I contract Fundación Santa Fe de Bogotá directly?
You can try. FSFB can discuss investigator interest, local procedure costs, and institutional ethics calendars. It cannot, by being named in Hancock Jaffe’s 2018 releases, become your INVIMA applicant, importer of record, insurer, ISO 14155 monitor, or FDA 21 CFR 812.28 packager. Contract the CRO that still runs Colombia first-in-human files, then let the CRO activate FSFB — or another pre-qualified site — as the hospital.
Who was the PI for the VenoValve FIH?
Dr. Jorge Ulloa, as stated on the live bioaccess® results page and in public two-year follow-up coverage. That fact does not make the PI your CRO.
What does the CRO still do if the hospital is already identified?
Regulatory-fit and country choice; the INVIMA and ethics packet; insurance; investigational import; contracts, training, and activation; ISO 14155 monitoring, EDC, SAE, and TMF; the English dataset and 21 CFR 812.28 narrative; and the option to add Panama or another Colombian site if FSFB is not enough. The hospital still does the surgery.
Is Colombia still recommended for new FIH?
Yes. bioaccess® still runs clinical trials in Colombia. We do not tell sponsors to take new first-in-human work out of the country. INVIMA review can move, stall, or ask again; a local entity treats that as a file problem. Panama remains available when the country page’s speed and bilingual profile fit the device better. See The Panama Clinic intercept if that is the hospital you actually found.
Next step
If the search that brought you here was Santa Fe or VenoValve, start as the operator: contact bioaccess®. Country system: CRO in Colombia. Program source: VenoValve Colombia results. Hub: LATAM FIH hospitals vs the CRO. Other sourced sites: The Panama Clinic, Hospital Italiano Asunción. Case studies: Axoft, Newrotex.