Sources: Arissa Medical press release of 8 October 2026 (arissamedical.com), NeuroNews International coverage of 8 October 2026 and 22 January 2024, and a ClinicalTrials.gov search run 15 October 2026. Public sources only. This page does not claim that bioaccess® ran, monitored, or advised on the Syntra study, and it does not claim the institute or its investigators as bioaccess® clients. General information, not legal or regulatory advice. Confirm current ISP, ethics, and FDA rules with qualified advisers.
If you searched Instituto de Neurocirugía Asenjo first-in-human, Instituto de Neurocirugía Dr. Alfonso Asenjo clinical trial, INCA Santiago neurovascular study, or “go direct to the Asenjo institute for an aneurysm device,” you found a real site. The Instituto de Neurocirugía Dr. Alfonso Asenjo in Santiago, Chile, is the public neurosurgery institute Arissa Medical names as the only site of its Syntra™ intrasaccular-device pilot. It is a serious neurovascular center. It is not a first-in-human medical-device CRO, and it is not the operator of the ISP file.
bioaccess®’s position is simple and it is not adversarial: the institute is the site. The First-in-Human CRO still owns ISP, accredited ethics, investigational import, insurance, ISO 14155 monitoring, and the FDA 21 CFR 812.28 package, plus the option to add another Latin American country if one neurovascular center is not enough. Sponsors who skip the CRO and email the cath lab still have to rebuild that stack.
What the public record says
- NeuroNews International, 22 January 2024: Arissa Medical enrolled the first patients in its first-in-human, early feasibility Syntra study for wide-necked sidewall and bifurcation cerebral aneurysms. Initial cases were done at the Instituto de Neurocirugía Dr. Alfonso Asenjo in Santiago by interventional neuroradiology principal investigator Dr. Juan Gabriel Sordo. Source.
- Arissa Medical, 8 October 2026: 12-month digital subtraction angiography follow-up was complete for all 16 patients in the prospective, single-arm pilot. The release reports 100% technical success, adequate occlusion (Raymond-Roy I–II) in 15 of 16 patients, zero retreatments, and zero device-related serious adverse events. It names the institute as the pilot site and Dr. Sordo as principal investigator, and it thanks Dr. Rodrigo Rivera, Chief of Neuroradiology, and the institute’s catheterization lab staff. Source; NeuroNews coverage.
- Study oversight named in the release: a UCLA-affiliated independent medical monitor and a blinded core lab. The release names no CRO. Arissa says it will seek FDA Breakthrough Device designation after the pilot closes. Syntra is limited to investigational use.
- ClinicalTrials.gov: a search on 15 October 2026 found no Syntra or Arissa record. The institute’s name does appear on older registry rows, such as the CHUM-sponsored TOBAS (NCT02098252) and PRET (NCT00626912) studies. We cite them only as facility evidence.
That is the leak: a founder reads a 16-patient neurovascular feasibility result, sees one Santiago institute and one PI, and no CRO, and concludes the hospital ran the whole study. It did not run the regulatory stack on its own. Something always owns import, insurance, monitoring, and the dataset an FDA reviewer will ask about.
The site is the site. The CRO is the operator.
What a neurovascular institute can typically do when a sponsor “goes direct”:
- Discuss investigator interest and whether the aneurysm caseload fits the protocol.
- Share institutional ethics and research-office calendars.
- Run the cases in its biplane cath lab with its neuroradiology team.
What the institute is not built to own for an investigational device:
- ISP and ethics. The investigational-device import and study authorization file, plus the Law 20.120 committee packet and every amendment.
- Investigational import. Permits, customs, and device accountability. See importer of record for clinical trial devices in Latin America.
- Clinical trial insurance. Required. We will not invent a premium here.
- ISO 14155 monitoring, EDC, SAE reporting, and the TMF.
- The 21 CFR 812.28 package. Foreign data is eligible for FDA submission and review once GCP and ethics documentation is in place. Eligibility is not clearance, and a site agreement does not produce it.
How ISP actually works (the short version)
Use clinical trials in Chile and Chile ISP: device vs. drug clinical trials. The Instituto de Salud Pública (ISP) governs investigational-device import and study authorization in Chile. An accredited Ethical-Scientific Committee under Law 20.120 still has to review the protocol, and a public hospital adds its own institutional authorization and research-office steps. Commercial ISP registration is a different file. Do not put trial authorization and commercial registration on one Gantt labeled “Chile.”
All bioaccess® device protocols are run under ISO 14155 and the Declaration of Helsinki. Data is designed to be eligible for FDA submission and review under 21 CFR 812.28 on a case-by-case basis. Eligibility is not a guarantee of clearance or approval. See OUS FIH data and the FDA IDE.
Do not smear the hospital
The Instituto de Neurocirugía Dr. Alfonso Asenjo is one of Chile’s reference neurosurgery centers, and the Syntra pilot shows its team can run a first-in-human neurovascular program. Use the site when the protocol fits. Hire the operator. This page is distinct from Clínica Santa María Santiago, where Dr. Sordo has also been listed, and from Clínica Alemana de Santiago. Sharing Santiago is not a license to merge them. The investigator-level page is Dr. Juan Gabriel Sordo: a Chile FIH principal investigator is not the CRO.
bioaccess® still runs clinical trials in Colombia
bioaccess® is the First-in-Human CRO for medical devices in Latin America, founded in 2010, with Miami headquarters and its own CRO in Colombia. bioaccess® still runs clinical trials in Colombia as well as Chile, Panama, and the rest of the platform. We pick the country the device needs.
Frequently asked questions
Can I contract the Instituto de Neurocirugía Asenjo directly for a device FIH?
You can start the conversation there. The institute can discuss investigator interest, caseload, and ethics calendars. It does not become your ISP applicant, importer of record, insurer, ISO 14155 monitor, or 21 CFR 812.28 packager because it hosted a pilot. Contract the CRO, then let the CRO activate the site if the site fits.
Did bioaccess® work on the Arissa Syntra study?
No. This page reports public sources only and claims no role in that study.
Is Syntra on ClinicalTrials.gov?
Not as of a 15 October 2026 search. A sponsor-named site with no CRO in the story is exactly why this page exists.
Next step
If the search that brought you here was this institute, start with the operator: contact bioaccess® or see First-in-Human CRO.
Julio G. Martinez-Clark, CEO · bioaccess®