Navitor Transcatheter Aortic Valve Implantation System
FDA PMAClass III (US FDA PMA)
Identity
- Trade Name
- Portico Transcatheter Aortic Valve Implantation System FDA PMA
- Generic Name
- Aortic valve, prosthesis, percutaneously delivered FDA PMA
Identifiers
- PMA Number
- P190023 FDA PMA
- FDA Product Code
- NPT FDA PMA
Classification
- Device Class
- Class III FDA PMA
- Advisory Committee
- Cardiovascular FDA PMA
- FDA Decision
- APPR Approved FDA PMA
The Navitor Transcatheter Aortic Valve Implantation System is a percutaneously delivered aortic valve prosthesis. It is indicated for the relief of aortic stenosis in patients with symptomatic heart disease due to severe native calcific aortic stenosis.
This device is intended for patients who are judged by a heart team, including a cardiac surgeon, to be at high or greater risk for open surgical therapy. The system is regulated under FDA PMA approval, with clinical risk assessments based on the Society of Thoracic Surgeons risk score and other clinical comorbidities.
Frequently asked questions
What is the primary purpose of the Navitor Transcatheter Aortic Valve Implantation System?
The system is a percutaneously delivered prosthetic aortic valve designed to provide relief for patients suffering from symptomatic heart disease caused by severe native calcific aortic stenosis.
Who is considered a candidate for this valve implantation system?
Candidates are patients with severe native calcific aortic stenosis who have been evaluated by a heart team, including a cardiac surgeon, and determined to be at high or greater risk for traditional open surgical therapy.
How is the patient's risk level determined for this procedure?
Risk is assessed by a heart team using the Society of Thoracic Surgeons risk score, which evaluates predicted surgical mortality, alongside other clinical comorbidities that may not be captured by the standard calculator.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them.
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_PMA
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA PMA | United States | FDA_PMA | P190023 | Class III | Active |
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Manufacturer
- Manufacturer
- Abbott Medical
Sources (1)
- FDA PMA P190023 24 fields · synced Sep 18, 2026