đź“Š Evidence-Based Reference
Adroit Guiding Catheter
Summary: The Adroit Guiding Catheter by Cordis is a device used primarily in venous-stent procedures. It is FDA 510k cleared with linked evidence from three PMCF studies, though specific outcomes and safety data are not detailed.
FDA Clearance Information
Pathway ?
510(k)
Number ?
K143412 ↗
Decision Date ?
January 14, 2015
Product Code ?
DQY Catheter, Percutaneous
Device Class ?
Class 2
Evidence ?
0 studies
The Adroit Guiding Catheter received FDA clearance through the 510k pathway on January 14, 2015. It is manufactured by Cordis and classified as a Class 2 medical device.
What It Is
The Adroit Guiding Catheter is designed to facilitate the placement of interventional devices within the vascular system. It is primarily used in procedures involving venous stents, providing support and guidance for other devices.
FDA-Cleared Indications
- Used to facilitate the introduction and guidance of interventional devices through the vascular system during percutaneous procedures.
- Intended for use in procedures requiring vascular access, catheter support, and device delivery under imaging guidance.
Clinical Applications
- Providing support for delivery of endovascular devices during percutaneous vascular procedures.
- Guiding devices through the iliac and central venous system when performing venous interventions.
- Supporting catheter-based treatment of peripheral vascular disease when compatible with the planned intervention.
- Facilitating device placement during image-guided endovascular procedures.
Reported off-label uses
- Use as a supportive guide catheter during selected complex peripheral arterial interventions, when the catheter's specifications and compatibility are appropriate.
- Use in selected venous recanalization or thrombectomy procedures as an access and device-delivery conduit.
Off-label use: these uses are reported in practice or the literature but are not part of the FDA-cleared indications. Physicians may use a cleared device off-label based on their medical judgment; the manufacturer may not promote off-label uses.
Evidence Summary
The available literature includes three PMCF studies registered on ClinicalTrials.gov. These studies focus on cardiology access procedures and peripheral arterial interventions, though specific participant numbers and outcomes are not detailed.
Reported Outcomes
Published studies report limited specific outcomes for the Adroit Guiding Catheter. The studies are ongoing, and detailed efficacy findings are not yet available in the provided evidence.
Safety Profile
Reported complications include general procedural risks associated with catheter use, though specific adverse events are not detailed in the available studies. Further data is needed to comprehensively assess safety.
Evidence Limitations
The current evidence lacks detailed outcome and safety data, as the studies are ongoing. Further research is needed to establish comprehensive efficacy and safety profiles for the Adroit Guiding Catheter.
Practical Considerations
- The correct catheter size, length, tip configuration, and internal diameter must match the access vessel, guidewire, and interventional device being used.
- Use is performed with fluoroscopic or other appropriate imaging guidance, typically through percutaneous arterial or venous access.
- The catheter should be flushed and handled according to the current Cordis instructions for use; resistance should not be overcome forcefully because this may cause vessel or device injury.
- MRI safety depends on the specific catheter model and whether it remains in the patient. The current product labeling should be reviewed before an MRI examination.
- Potential complications include vascular injury, bleeding or hematoma at the access site, thrombosis, embolization, infection, catheter damage, and contrast-related reactions.
Procedures that use this device
Frequently Asked Questions
What are the clinical indications for Adroit Guiding Catheter?
The catheter is indicated for use in venous-stent procedures, particularly in cardiology and peripheral vascular interventions.
What outcomes have been reported in clinical studies?
Specific outcomes have not been detailed in the available studies, as they are ongoing.
What complications have been reported?
Reported complications include general procedural risks, but specific adverse events are not detailed in the current evidence.
Disclaimer: This page compiles publicly available regulatory and published clinical evidence for educational reference.
It does not constitute medical advice, product endorsement, or a recommendation for clinical use.
Always consult manufacturer documentation and clinical judgment for patient care decisions.