Figures cited from named public press, the live Hospital Italiano Asuncion intercept, the bioaccess® Supira program page, and DINAVISA-related country copy, verified 23 August 2026. General information, not legal or regulatory advice. Confirm current DINAVISA and FDA rules with qualified advisers. We name only the PI, hospital aliases, and trials those sources support. We do not claim Protaryx, Artio, NuVera, Thoratec, or Vascudyne as bioaccess® clients. Supira is cited from a live bioaccess® page; we do not invent a CRO sentence the 2022 sponsor release does not contain.
If you searched Adrian Ebner first-in-human, Adrián Ebner Paraguay clinical trial, Sanatorio Italiano Asuncion FIH, or go direct to the PI in Paraguay, you are following an investigator name that is genuinely in the public file. Dr. Adrián Ebner, Head of Cardiovascular at Sanatorio Italiano / Hospital Italiano / Italian Hospital, Asunción, is a real first-in-human cardiovascular investigator. He is not the operator of the DINAVISA file.
bioaccess®’s position is simple and it is not adversarial: Dr. Ebner and the Italian Hospital are the site. The First-in-Human CRO still owns DINAVISA, investigational import, insurance, ISO 14155 monitoring, and the FDA 21 CFR 812.28 package — plus the option to add Colombia or Panama if Asunción is not the only fit. Sponsors who skip the CRO and email the PI still have to rebuild that stack. A press release that names the surgeon does not make the surgeon a CRO.
This page is the PI-query intercept. The hospital-query intercept is already live at Hospital Italiano Asunción FIH. The program narrative stays at Supira Medical first-in-human trial, Paraguay. Do not treat this page as a second hospital essay. It answers the investigator-named search.
Why the PI name wins the search — and why that is not a CRO
Device press writes the implant, the city, and the surgeon. It rarely writes the CRO. Dr. Ebner is a repeated public example of that pattern. The hospital names in those releases vary — Sanatorio Italiano, Hospital Italiano, Italian Hospital Asunción — and we will use the alias each source used rather than collapsing them into a name we invented.
Named first-in-human press we will stand behind (verified 23 August 2026), with the CRO rule stated once so it is not missed:
- Protaryx transseptal puncture — December 2024. Cardiac Rhythm News reports completion of a first-in-human study on 3 December 2024 at Sanatorio Italiano de Asunción; five patients; ethics approval from the Research Ethics Committee of the Paraguayan Institute of Social Studies; procedures by Adrian Ebner, head of the cardiovascular department at the Sanatorio Italiano Hospital, with guidance by Gagan Singh (UC Davis). The release discusses 510(k) intent. Not a bioaccess® client claim.
- Artio Amplifi vein dilation system — 2021. Interventional News reports Artio completed enrolment of a first-in-human study; five patients treated by Adrian Ebner, head of the Cardiovascular Department at Sanatorio Italiano Hospital in Asunción. Not a bioaccess® client claim.
- NuVera NuVision ICE catheter — July 2020. PR Newswire (6 July 2020) and Cardiac Rhythm News: first-in-human use; first participant treated for an atrial septal defect by PI Adrian Ebner, M.D., Head of the Cardiovascular Department at the Italian Hospital Asunción, with remote live-feed support from the NuVera team in the U.S. Not a bioaccess® client claim.
- Thoratec HeartMate PHP — 2013. DAIC (28 March 2013): first human use of HeartMate PHP during high-risk PCI; procedures by Adrian Ebner, M.D., at Sanatorio Italiano in Asunción; chief of the Cardiovascular Department. Not a bioaccess® client claim.
- Vascudyne TRUE Vascular Graft. Company / OTS release: first-in-human use for hemodialysis access; first procedures by Adrian Ebner, MD, Director of Endovascular and Cardiovascular Surgery at Sanatorio Italiano in Asunción, as part of an early feasibility study; five patients in that announcement. Later literature lists Ebner among authors of a first-in-human evaluation of the TRUE AVC conduit. Not a bioaccess® client claim.
- Supira pVAD — September 2022. Sponsor release (16 September 2022) names PI Adrian Ebner at the Italian Hospital Asunción. The live bioaccess® program page places the same FIH at that hospital and reports later South American experience, Breakthrough designation, U.S. EFS (November 2024), and SUPPORT II (April 2026) as published there. We cite the bioaccess® page. We do not invent a CRO sentence the 2022 sponsor copy does not contain.
That list is how a sponsor finds Dr. Ebner without finding the operator. It is also how a founder concludes that emailing the PI is the whole first-in-human plan. It is not. DINAVISA still exists after you have the name.
The PI is a site. The CRO is the operator.
An Asunción cardiovascular department can provide the cath lab, imaging, and an investigator who has taken several public first-in-human devices through first cases, sometimes with visiting or remote U.S. advisors. 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 PI / hospital can typically do when a sponsor goes direct:
- Discuss investigator interest and procedural feasibility — when that service is available and appropriate for your device, which is not automatic.
- Share institutional ethics-committee calendars and hospital research rules.
- Quote procedure, bed, and local staffing costs for the cases they will physically run.
What the PI is not built to own for an investigational device:
- DINAVISA. Paraguay’s national sanitary authority (Dirección Nacional de Vigilancia Sanitaria) is the file a sponsor actually needs. A hallway conversation with a surgeon is not that file.
- Investigational import. Ethics letter, investigator’s brochure, and 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 an Asunción-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. Eligibility is not clearance. Supira’s later U.S. EFS and SUPPORT II path, as published on the bioaccess® page, is exactly why the early Latin American dataset has to be built as a file, not as a souvenir implant.
- Multi-country optionality. If Paraguay enrollment or the indication later needs Colombia or Panama, a single-PI MSA will not stretch.
Going direct to Dr. Ebner is how you confirm a room and a surgeon. It is not how you open a first-in-human investigation.
How DINAVISA sits next to the PI (the short version)
The hospital intercept already states this. We repeat it here because the PI query is a different Google, not a different file.
DINAVISA is the national sanitary authority. Ethics sits with the institutional committee — Protaryx press, for example, names the Research Ethics Committee of the Paraguayan Institute of Social Studies for that study. Import sits on a permit. Monitoring sits on ISO 14155. Those layers are why a CRO exists after you already know Dr. Ebner’s name.
We will not invent a median DINAVISA day-count. The clocks we will repeat are already published elsewhere on bioaccessla.com and are country-specific, not PI-specific: Panama ethics 3-5 weeks and 6-8 weeks to first patient with bioaccess® coordination on clinical-trials-panama; Colombia ethics 4-6 weeks and per-patient $15,000-$25,000 on that same comparison. Ask for a Paraguay protocol-specific calendar.
All bioaccess® Latin American device protocols are designed under ISO 14155 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 CRO still does after you have a PI name
- Regulatory-fit, not tourism. Paraguay has a dense public cardiovascular FIH press file at this investigator. It is not automatically the right country for every indication. bioaccess® still runs trials in Colombia and Panama.
- Protocol, IB, ICF, insurance, and the DINAVISA 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.
- ISO 14155 monitoring and the 21 CFR 812.28 narrative — 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.
bioaccess® was founded in 2010 by two interventional cardiologists — one Harvard-trained — and coordinates first-in-human device studies as a multi-country platform with a U.S. sponsor desk. That is the operator layer around a named Asunción PI.
Do not smear the investigator
Dr. Ebner’s cardiovascular service and Sanatorio Italiano / Hospital Italiano Asunción are serious clinical resources. This page is not a critique of the PI. Visiting or remote U.S. advisors in the public releases are a signal of procedural seriousness, not a substitute for a CRO quality system. Use the site. Hire the operator. For the hospital-named search, stay on Hospital Italiano Asunción FIH.
Colombia is still on the map
A Paraguay PI 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® — local entity and office, Miami headquarters, INVIMA clocks in-country. The founder podcast, when a conversation needs a voice, is Global Trial Accelerators™.
Site versus CRO
| Workstream | Dr. Ebner / the site | bioaccess® / the CRO |
|---|---|---|
| Procedure | Cath lab, imaging, CV department, PI | Protocol fit, training, device accountability |
| Ethics | Institutional committee calendar | Packet, ICF, IB, deficiency responses |
| National authority | Not the permit holder by being named in press | DINAVISA |
| Import | Receiving and storage if contracted | Importer of record |
| Quality / FDA | Source documents from the cases | ISO 14155 + 21 CFR 812.28 narrative |
| Next country | One service in Asunción | Colombia (INVIMA) and Panama (MINSA/CNBI) still on the platform |
Frequently asked questions
Can I contract Dr. Ebner or Sanatorio Italiano directly?
You can try. A hospital can discuss investigator interest, local procedure costs, and institutional ethics calendars. It cannot, by being named in Protaryx, Artio, NuVera, Thoratec, Vascudyne, or Supira press, become your DINAVISA applicant, importer of record, insurer, ISO 14155 monitor, or FDA 21 CFR 812.28 packager. Contract the CRO, then let the CRO activate the site.
Which of these programs is on a bioaccess® page?
Supira pVAD is on the live bioaccess® Paraguay program page and on the Hospital Italiano intercept. Protaryx, Artio Amplifi, NuVera NuVision ICE, Thoratec HeartMate PHP, and Vascudyne TRUE graft are named public press. We will not invent a CRO role on those five.
What does the CRO still do if the PI is already identified?
Regulatory-fit and country choice; the DINAVISA 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 Colombia or Panama if Asunción is not enough. The hospital still does the procedure.
Is this the same page as Hospital Italiano Asunción FIH?
No. That page is the hospital-named intercept, centered on the Supira public file. This page is the PI-named intercept and lists the broader press file without converting those sponsors into clients.
Next step
If the search that brought you here was Adrian Ebner or Sanatorio Italiano, start as the operator: contact bioaccess®. Hospital page: Hospital Italiano Asunción FIH. Program: Supira Paraguay. Clinic hub: ophthalmic FIH clinics vs CRO. Hospital hub: LATAM hospitals vs CRO. Country: Colombia, Panama.