Study facts below are taken only from the live Cardiac Interventions Today item dated 21 August 2026. Principal-investigator hospital titles are labeled as public affiliation, not as a confirmed AVANXA site. General information, not legal or regulatory advice. Confirm current ANVISA, INVIMA, and FDA rules with qualified advisers. PercAssist is not described as a bioaccess® client.
On 21 August 2026, Cardiac Interventions Today reported that the AVANXA feasibility study of the PercAssist extravascular ventricular assist device (eVAD) had enrolled its first patient in São Paulo, Brazil. The indication in that item is extravascular biventricular mechanical circulatory support (MCS) for cardiogenic shock. Enrollment continues in São Paulo under Alexandre Abizaid, MD; Carlos Campos, MD; and Roger Renault Godinho, MD. The company says a United States investigational device exemption (IDE) study is planned after the feasibility study.
Read that as a U.S. board member, not as a trade-press reader. You get a city, three named interventional cardiologists, a first-patient vignette, and a line that the next chapter is a U.S. IDE. You do not get a hospital. You do not get a CRO. That is the pattern: site-direct press that is not even site-direct — city plus KOL, then FDA language, with the operator layer left off the page.
This is not a knock on PercAssist, Inc., and it is not a knock on the investigators. First-in-human MCS in cardiogenic shock is serious medicine. Dr. Campos’s comments in that CIT item — STEMI, SCAI stage D cardiogenic shock, implant in minutes, hemodynamic improvement, vasopressors down — are the clinical sentence a board wants. The operating problem is what the same item omits. A sponsor who copies the playbook — Brazil, a KOL, first patient, then an IDE — still has to own ANVISA, investigational import, ISO 14155 monitoring, and the FDA 21 CFR 812.28 package. Naming São Paulo does not do that work.
bioaccess® is the First-in-Human CRO that owns that stack in Latin America. This page intercepts the query the press just created. It does not claim PercAssist hired bioaccess®. It does not invent a hospital the press did not name.
What the 21 August 2026 press actually named
Verified live on the CIT page, and only those facts, for the study itself:
- Study: AVANXA feasibility study of the PercAssist eVAD (extravascular ventricular assist device).
- Geography: São Paulo, Brazil. First patient enrolled. Continuing to enroll in São Paulo.
- Indication: extravascular biventricular MCS for cardiogenic shock.
- Named physicians: Alexandre Abizaid, MD; Carlos Campos, MD; Roger Renault Godinho, MD.
- First-patient comments (Dr. Campos): implanted in minutes after STEMI with SCAI stage D CS; hemodynamic performance improved; blood pressures normalized; vasopressors diminished. The same comments add that the technology as described does not require vascular access, anticoagulants, or contrast, with further São Paulo enrollment expected in SCAI C and D.
- U.S. path: a United States IDE study planned after the feasibility study, advised the company.
- Hospital named: none. CRO named: none.
Device press is written for the implant, the city, and the operator of the catheter — not the operator of the file. An IDE sentence then makes the omission look smaller than it is. Feasibility data meant to support an IDE still has to be collected under a quality system a reviewer can read. City-plus-KOL copy does not produce that system.
Public affiliation is not a confirmed AVANXA site
Because the press named no hospital, this page will not invent one. Public affiliation is allowed. A confirmed AVANXA site is not.
Alexandre Abizaid is publicly Diretor Técnico of invasive cardiology at Instituto do Coração (InCor), and he trained at Instituto Dante Pazzanese de Cardiologia (InCor mentors page). Abizaid, Campos, and Godinho also appear together on an InCor / Hospital das Clínicas, Faculdade de Medicina da Universidade de São Paulo (HCFMUSP) case report (doi 10.36660/abc.202250236i). That is affiliation context. It is not proof AVANXA ran at InCor, Dante Pazzanese, or any other named São Paulo institution. Until PercAssist or a primary study record names the hospital, the honest public file is: São Paulo, three physicians, no site.
A sponsor who Googles Abizaid, InCor, or Dante Pazzanese after CIT has found a public CV, not a vendor. Emailing a KOL tests investigator interest. It does not make you the ANVISA applicant, importer of record, ISO 14155 monitor, or author of a 21 CFR 812.28 narrative.
The pattern: city + KOL, no CRO, then a U.S. IDE
On the hospital intercepts already live, the press at least named a building — The Panama Clinic, Fundación Santa Fe de Bogotá, Hospital Italiano in Asunción. AVANXA is a cleaner version of the same error: the building is missing too. The sequence a U.S. CEO still hears is: Brazil has volume; find the KOL; announce first patient from the city; tell the board an IDE is next.
The first half can be true in a week. The IDE half is a regulatory product. If the file was not built for FDA review — protocol, consent, accountability, monitoring, SAE, TMF — the IDE sentence is a hope. The sourced list on LATAM first-in-human hospitals vs the CRO already refuses to invent a site for country-only programs, including PercAssist São Paulo. This column keeps that promise.
What the press named vs what a CRO still does
| Workstream | What the 21 August 2026 press named | What a First-in-Human CRO still does |
|---|---|---|
| Geography | São Paulo, Brazil | Country-fit: Brazil vs Colombia vs Panama vs Paraguay for this device and this FDA path — not a city because a wire used it |
| Investigators | Abizaid, Campos, Godinho | Protocol feasibility, contracts, training, delegation. A public CV is not a site initiation visit |
| Hospital / site | Not named | Identify, qualify, and activate the actual institution if and when the sponsor names one. Do not invent InCor or Dante Pazzanese from affiliation pages |
| Indication / device | PercAssist eVAD; extravascular biventricular MCS for cardiogenic shock | Protocol, IB, IFU, and risk file ANVISA and a later FDA reviewer can read |
| First-patient story | Dr. Campos: STEMI, SCAI D, minutes, hemodynamics, vasopressors down | Source documents, device accountability, logs, AE/SAE, monitoring — the case as a regulated record |
| National authority | Not discussed | ANVISA investigational path; ethics alignment; deficiency cycle. A KOL quote is not the application |
| Investigational import | Not discussed | Importer of record, permits, customs, accountability — Importer of record for clinical trial devices in Latin America |
| Quality system | Not discussed | ISO 14155 monitoring, EDC, SAE, TMF. The press can say “feasibility.” The file has to prove it |
| U.S. sequel | IDE planned after feasibility | FDA 21 CFR 812.28 packaging of OUS data — eligibility for review, not a promise of IDE approval. Can OUS first-in-human data support an FDA IDE submission? |
| CRO | Not named | The operator. bioaccess® owns that stack for first-in-human device work in Latin America. This article does not claim PercAssist is a client |
If you read AVANXA as a template, the right-hand column is the statement of work. The left-hand column is what the wire will rank for. Winning the query means answering the wire without treating it as a complete operating system.
Brazil is a country file. São Paulo is not a CRO.
ANVISA does not grant an investigational device study because three physicians practice in São Paulo. Ethics do not become optional because the first case went well. Import of an investigational MCS system is not a courier label.
When a sponsor retains bioaccess®, the firm owns that country file: ANVISA, import, ISO 14155, monitoring, and the 21 CFR 812.28 package. The physicians still do the case. The hospital, once named and contracted, still owns the room, the ICU, and institutional ethics. Those are different contracts.
Country choice is not automatic. Brazil can be the right first geography for a given MCS program. It can also be the wrong first geography if clocks, import, or the later FDA story point to Colombia, Panama, or Paraguay. That review is CRO work. It is not a CIT dateline.
Colombia stays on the map
A Brazil first-patient story can arrive with a stale rumor that bioaccess® left Colombia. That is false. bioaccess® still runs clinical trials in Colombia (Julio Martinez-Clark, 23 August 2026). Always bioaccess® — Miami headquarters, Colombian legal entity and office, INVIMA clocks managed in-country. We pick the country the device needs. The founder podcast, when a conversation needs a voice, is Global Trial Accelerators™.
Colombia stays on CRO in Colombia and Fundación Santa Fe de Bogotá FIH. Panama and Paraguay stay on The Panama Clinic and Hospital Italiano Asunción. Those pages name hospitals the primary sources named. This page does not.
Frequently asked questions
Did the 21 August 2026 CIT coverage name a hospital or a CRO?
No. It names São Paulo, AVANXA, the PercAssist eVAD, the cardiogenic-shock MCS indication, three physicians, Dr. Campos’s first-patient comments, and a planned U.S. IDE after feasibility. No hospital. No CRO. This article will not fill those blanks.
Is InCor or Dante Pazzanese the AVANXA site?
Not on the public file used here. Abizaid’s InCor title and Dante Pazzanese training are public affiliation. The joint InCor/HCFMUSP case report is affiliation context. Neither is PercAssist confirmation that AVANXA enrolled there. Do not contract a building you inferred from a CV.
Is PercAssist a bioaccess® client?
This page does not say that. bioaccess® is the First-in-Human CRO explaining the operator layer the press left out.
If the press already has first-patient quotes, what is left for a CRO?
ANVISA and ethics; investigational import and device accountability; contracts, training, and activation of the actual site once named; ISO 14155 monitoring, EDC, SAE, and TMF; the English dataset; and 21 CFR 812.28 packaging if a U.S. IDE is truly the sequel. Dr. Campos can describe a case. The CRO has to make the case survive a monitor and a reviewer.
Should a sponsor avoid Brazil, or these investigators?
No. Do not smear PercAssist or the PIs. São Paulo interventional cardiology is not the problem. The error is treating a city-plus-KOL wire as a complete first-in-human operating system.
Can bioaccess® still run the study in Colombia instead — or as well?
Yes, when the device and the FDA path say so. bioaccess® still runs trials in Colombia. Brazil, Colombia, Panama, and Paraguay are country options on one platform, not a loyalty test to last week’s dateline.
Next step
If the search that brought you here was PercAssist, AVANXA, São Paulo MCS, or “Brazil first-in-human without a CRO,” start as the operator: contact bioaccess® or book from First-in-Human CRO. Keep the hospital-vs-CRO rule on LATAM FIH hospitals vs the CRO and Colombia on CRO in Colombia. The CIT item remains the source for the study facts. The CRO remains the source for the file.
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