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Phenom 27 Catheter
Cathera
Product: Solitaire X-PACK — all models and sizes
Summary: The Phenom 27 Catheter by Cathera is a Class 2 device cleared by the FDA for use in venous stenting. It is supported by two studies, highlighting its application in complex neurointerventions.
FDA Clearance Information
Pathway ?
510(k)
Number ?
K180959 ↗
Decision Date ?
June 11, 2018
Product Code ?
DQY Catheter, Percutaneous
Device Class ?
Class 2
Evidence ?
0 studies
The Phenom 27 Catheter received FDA clearance through the 510(k) pathway on June 11, 2018. It is manufactured by Cathera and classified as a Class 2 medical device.
What It Is
The Phenom 27 Catheter is a distal access catheter designed for use in neurointerventional procedures, particularly in the placement of flow diverters for cerebral aneurysms. It facilitates access to complex vascular anatomies.
FDA-Cleared Indications
- Percutaneous catheter use within the cardiovascular system, consistent with FDA product code DQY and 21 CFR 870.1250.
- The supplied FDA summary does not state a complete disease-specific or procedure-specific indication.
Clinical Applications
- Use as a percutaneous catheter during procedures that match the device's current FDA-cleared labeling.
- Use in catheter-based vascular procedures when the catheter's labeled size, compatibility, and intended anatomy are appropriate.
Reported off-label uses
- Use as a distal access catheter for neurointerventional procedures, including navigation toward intracranial aneurysms, has been described for this device type but should not be assumed to be FDA-cleared without reviewing the current labeling.
- Use to support delivery of neurovascular implants such as flow-diverter devices has been described in clinical practice; this is not confirmed as an FDA-cleared indication by the information supplied.
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 two studies: a case report from 2025 and a case series from 2021. These studies explore the catheter's use in neurointerventional procedures, particularly focusing on its application in flow diversion.
Reported Outcomes
Published studies report successful use of the Phenom 27 Catheter in complex neurointerventions, such as flow diverter placement for cerebral aneurysms. The case series highlights advantages like reduced procedure time and fewer access-site complications when using transradial access.
Safety Profile
Reported complications include potential challenges in navigating complex vascular anatomy. However, specific adverse events or complications were not detailed in the provided studies.
Evidence Limitations
The evidence is limited to a case report and a case series, which may not provide comprehensive data on long-term outcomes or rare complications. Further research is needed to establish broader safety and efficacy profiles.
Practical Considerations
- Confirm the current Instructions for Use before selecting the catheter; the supplied record does not include the catheter's dimensions, working length, inner diameter, outer diameter, or compatible guidewire and delivery-system specifications.
- Verify compatibility with the intended access sheath, guide catheter, guidewire, contrast medium, and any implant or treatment system.
- Use fluoroscopic or other appropriate imaging guidance and follow institutional protocols for catheter advancement, flushing, and handling.
- MRI safety information is not provided in the supplied FDA record. Check the current labeling for MR Safe, MR Conditional, or MR Unsafe status before MRI.
- Potential risks are those associated with percutaneous catheterization and the treated vascular system, including vascular injury, bleeding, thrombosis, embolization, infection, contrast reaction, and ischemic complications.
Procedures that use this device
Frequently Asked Questions
What are the clinical indications for Phenom 27 Catheter?
The Phenom 27 Catheter is indicated for use in neurointerventional procedures, particularly for the placement of flow diverters in cerebral aneurysms.
What outcomes have been reported in clinical studies?
Studies report successful navigation and placement of flow diverters with reduced procedure time and fewer access-site complications using the Phenom 27 Catheter.
What complications have been reported?
Reported complications include challenges in navigating complex vascular anatomy, though specific adverse events were not detailed in the studies.
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.