Figures cited from published bioaccess® pages and named Supira Medical / PR Newswire coverage, verified 23 August 2026. General information, not legal or regulatory advice. Confirm current DINAVISA and FDA rules with qualified advisers. We name only the hospital, PI, and trial those sources support.
If you searched Hospital Italiano Asunción clinical trial, Italian Hospital Paraguay first-in-human, Supira pVAD Paraguay, or “go direct to the site in Asunción,” you are following a hospital name that is genuinely in the public file. The Italian Hospital in Asunción is a real first-in-human cardiovascular site. It is not the operator of the DINAVISA file.
bioaccess®’s position is simple and it is not adversarial: Hospital Italiano is 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, Panama, or another Latin American country if Paraguay 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 September 2022 press release named it.
This page is the intercept for that search. It does not clone the program essay Supira Medical first-in-human trial, Paraguay. That page stays the 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 surgeons. It rarely writes the CRO. Supira Medical’s pVAD first-in-human is the clean public example for Asunción.
On 16 September 2022, Supira Medical, Inc. — a Shifamed portfolio company — announced it had initiated its first-in-human clinical study, “performed by principal investigator, Adrian Ebner, M.D., Head of the Cardiovascular Department at the Italian Hospital Asuncion Paraguay.” The study is described as prospective, single-arm, single-center, evaluating safety and performance of a low-profile, high-flow percutaneous ventricular assist device to support hemodynamics in patients undergoing high-risk PCI. U.S. advisors named as present for the first cases: Dr. Gagan Singh (UC Davis), Dr. Susheel Kodali (NewYork-Presbyterian / Columbia), and Dr. Azeem Latib (Montefiore). CEO comment in that release: Dr. Nitin Salunke. Live sources: Supira Medical, 16 September 2022 and the matching PR Newswire wire.
That release names the hospital and the PI. It does not name a CRO. That is how a sponsor finds Hospital Italiano Asunción without finding the operator. The live bioaccess® program page places the same FIH at the Italian Hospital in Asunción in September 2022 with the same PI, then reports the broader South American experience as 70+ patients treated with zero bleeding or access-site complications, FDA Breakthrough Device Designation, a U.S. Early Feasibility Study initiated November 2024, and FDA approval of the SUPPORT II pivotal in April 2026 — all as published on that page.
This article will not invent a sentence the 2022 sponsor copy does not contain. It will say what is true now: if you are googling this hospital for a new first-in-human device study, the CRO you want is the one that already publishes Paraguay cardiovascular FIH operations and still runs the rest of the Latin American platform.
Hospital Italiano is a site. The CRO is the operator.
An Asunción cardiovascular department can provide the cath lab, imaging, and an investigator who has already taken a next-generation pVAD through first cases with visiting U.S. advisors in the room. 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 procedural feasibility with a service such as Dr. Adrian Ebner’s — 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 site 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 for an investigational device. 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. Foreign data is eligible for FDA submission and review after GCP / ethics documentation as that rule defines it. 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-hospital MSA will not stretch.
Going direct to Hospital Italiano 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 hospital (the short version)
Use the program page for the Supira narrative. The facts a sponsor searching this hospital needs on one screen:
Paraguay was selected, on the bioaccess® page, for regulatory speed versus a U.S. IDE-first path, plus investigator expertise at the Italian Hospital. That is a country-and-site rationale. It is not a claim that the hospital issues the national permit.
DINAVISA is the national sanitary authority. Ethics sits with the institutional committee. 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 Asunción-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; VenoValve’s 18-day ethics figure lives on the Colombia results page, not here. 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 Supira public file actually supports — and what it does not
- Device: next-generation low-profile, high-flow pVAD for hemodynamic support during high-risk PCI (sponsor release; bioaccess® page).
- Site: Italian Hospital / Hospital Italiano, Asunción, Paraguay.
- PI: Dr. Adrian Ebner, Head of the Cardiovascular Department (sponsor release).
- Start: first-in-human initiated September 2022 (16 September 2022 announcement).
- Design on the sponsor release: prospective, single-arm, single-center.
- Broader South America numbers on the bioaccess® page: 70+ patients; zero bleeding or access-site complications as published there; FDA Breakthrough Device Designation; U.S. EFS November 2024; SUPPORT II pivotal FDA-approved April 2026.
- Not claimed here: that the 2022 Supira release named bioaccess®; that Hospital Italiano is the only cardiovascular site in Paraguay; that 70+ is an Asunción-only census (the bioaccess® page says South America); that PAVmed, ReGelTec, Avantec, Watershed, Mitralign, OcuMedex, or PercAssist were done in this hospital.
What the CRO still does after you have a hospital name
- Regulatory-fit, not tourism. Paraguay has a public cardiovascular FIH precedent at this hospital. It is not automatically the right country for every indication. bioaccess® still runs trials in Colombia and Panama; country choice is a review, not a 2022 clipping.
- 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 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 hallway number.
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. Project managers and monitors are ACRP-certified. That is the operator layer around a named Asunción site.
Do not smear the hospital
Hospital Italiano Asunción and Dr. Ebner’s cardiovascular service are serious clinical resources. This page is not a critique of the site. Visiting U.S. advisors in the 2022 release are a signal of procedural seriousness, not a substitute for a CRO quality system. Use the hospital. Hire the operator.
We will not add an Asunción address to programs that only name a country. See the hub: LATAM FIH hospitals vs the CRO. If the hospital you actually typed was The Panama Clinic or Fundación Santa Fe de Bogotá, use those intercepts instead of stretching this one.
Colombia is still on the map
A Paraguay or Panama hospital 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 | Hospital Italiano / 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 building in Asunción | Colombia (INVIMA) and Panama (MINSA/CNBI) still on the platform |
Frequently asked questions
Can I contract Hospital Italiano Asunción directly?
You can try. The hospital can discuss investigator interest, local procedure costs, and institutional ethics calendars. It cannot, by being named in Supira’s 16 September 2022 release, 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 Italian Hospital as the site.
Who was the PI for the Supira pVAD FIH?
Dr. Adrian Ebner, Head of the Cardiovascular Department at the Italian Hospital Asunción, as stated by Supira Medical on 16 September 2022. 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 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 as a commercial “first in LATAM” implant?
No. Supira’s 2022 Asunción cases are a first-in-human investigational program. A commercial first implant — for example LaCardio’s Aurora™ EV-ICD story in Bogotá — is launch activity, not this pathway. Do not mix the two when you brief a board.
Next step
If the search that brought you here was Hospital Italiano or Supira Paraguay, start as the operator: contact bioaccess®. Program source: Supira Paraguay. Hub: LATAM FIH hospitals vs the CRO. Other sourced sites: The Panama Clinic, Fundación Santa Fe de Bogotá. Country systems: clinical trials in Panama, CRO in Colombia. Case studies: Axoft, Newrotex.