generated: '2026-08-05'
method: searched
source: >-
  Procyrion press releases on www.procyrion.com, the ClinicalTrials.gov v2 API, and
  trade-press coverage (2026-08-05)
scope: >-
  Procyrion publishes no API, so there are no API or cross-cutting technical standards to
  assert. What it is actually measured against is the US medical device regulatory pathway
  and the medical device quality-management standard. Those are recorded here as the
  applicable regimes, with status stated honestly. The API/protocol standards block below
  is recorded as not-applicable rather than false, so this file is never mistaken for an
  API posture the company does not claim.
regulatory_regime:
- id: iso-13485-2016
  name: ISO 13485:2016 - Medical devices, quality management systems
  conforms: true
  status: certified
  evidence: >-
    Procyrion announced ISO 13485:2016 certification for its medical device and quality
    management systems in May 2018, on its own press-release page.
  source: https://www.procyrion.com/news/procyrion-inc-announces-iso-13485-2016-certification
  note: >-
    This is a device-manufacturing quality certification, not a published information
    security or API compliance program, so it does not earn a `Compliance` pointer in
    apis.yml. Recorded here for what it is.
- id: fda-breakthrough-device-designation
  name: US FDA Breakthrough Device Designation
  conforms: true
  status: granted
  granted: '2019-07-30'
  evidence: >-
    FDA granted Breakthrough Device Designation to the Aortix System for chronic heart
    failure patients hospitalized with acute decompensated heart failure and worsening
    renal function.
  source: https://www.procyrion.com/news/procyrion-receives-fda-breakthrough-device-designation-for-aortix-tm-system
- id: fda-ide-pivotal-trial
  name: US FDA Investigational Device Exemption (IDE) pivotal trial
  conforms: false
  status: in-progress
  evidence: >-
    The DRAIN-HF pivotal IDE trial (NCT05677100, "Diuretics Alone vs. Aortix Endovascular
    Device for Acute Heart Failure") began 2023-08-23 and is RECRUITING as of 2026-08-05,
    with a target enrollment of 320 across US centers.
  source: https://clinicaltrials.gov/study/NCT05677100
  note: >-
    conforms:false records that PMA/market authorization has not been granted, not that a
    check was failed. Aortix is limited by federal law to investigational use and is not
    approved for sale in any geography.
- id: fda-premarket-authorization
  name: US FDA premarket authorization for commercial sale
  conforms: false
  status: not-granted
  evidence: >-
    Procyrion's own disclaimer and overview pages state that Aortix "is not available for
    sale in any geography" and is for investigational use only; the EU statement is
    "Exclusively for Clinical Investigations in the European Union".
  source: https://www.procyrion.com/disclaimer
clinical_trials:
  source: https://clinicaltrials.gov/api/v2/studies?query.spons=Procyrion
  fetched: '2026-08-05'
  studies:
  - nct_id: NCT05677100
    title: Diuretics Alone vs. Aortix Endovascular Device for Acute Heart Failure (DRAIN-HF)
    status: RECRUITING
    start: '2023-08-23'
    enrollment: 320
  - nct_id: NCT04145635
    title: The Aortix CRS Pilot Study
    status: COMPLETED
    start: '2021-02-05'
    enrollment: 21
  - nct_id: NCT04999163
    title: Aortix Therapy for Perioperative Reduction of Kidney Injury
    status: TERMINATED
    start: '2022-07-17'
    enrollment: 20
api_standards:
- id: openapi
  conforms: false
  applicable: false
  evidence: no public API contract published (see well-known/procyrion-well-known.yml)
- id: oauth2
  conforms: false
  applicable: false
- id: openid-connect
  conforms: false
  applicable: false
- id: rfc9457-problem-details
  conforms: false
  applicable: false
- id: asyncapi
  conforms: false
  applicable: false
- id: graphql
  conforms: false
  applicable: false
  evidence: /graphql returns 404 on www.procyrion.com
- id: mcp
  conforms: false
  applicable: false
- id: a2a
  conforms: false
  applicable: false
  evidence: >-
    /.well-known/agent-card.json and /.well-known/agent.json both return 404 on
    www.procyrion.com
- id: rfc9116-security-txt
  conforms: false
  applicable: true
  evidence: /.well-known/security.txt returns 404 on www.procyrion.com
information_security_compliance:
  found: false
  note: >-
    No trust center, SOC 2, ISO 27001 or equivalent information-security certification page
    was found by probe-security-programs.py (vdp=none trust=none) or by search;
    trust.procyrion.com and security.procyrion.com do not resolve. No `Compliance` and no
    `TrustCenter` pointer is wired in apis.yml.
domain_security_observed:
  source: security/procyrion-domain-security.yml
  summary: >-
    www.procyrion.com serves TLS 1.3 with HSTS (max-age 31536000), and procyrion.com has
    DNSSEC, SPF and DMARC records present; DMARC policy is p=none (monitor only) and no CAA
    record is published.