Phenom Catheters
Micro Therapeutics Lnc. D/B/A Ev3 Neurovascular
Product: PhenomTM 21 Catheter — all models and sizes
FDA Clearance Information
Phenom catheters were cleared by the FDA through the 510k pathway on February 25, 2021. Manufactured by Micro Therapeutics Lnc., they are classified as Class 2 devices.
What It Is
FDA-Cleared Indications
- Percutaneous introduction into blood vessels during diagnostic or interventional procedures.
- Delivery of compatible interventional devices, fluids, or contrast media through the vascular system, as applicable to the specific catheter configuration.
- Use by trained clinicians when the catheter size and features are appropriate for the target anatomy and intended procedure.
Clinical Applications
- Endovascular access and catheter navigation through selected blood vessels.
- Support for delivery of compatible devices during vascular interventions.
- Selective vascular access for procedures performed under fluoroscopic or other image guidance.
Reported off-label uses
- Use as a distal access catheter in selected neurovascular interventions, including support for treatment of cerebral aneurysms, when the specific configuration is not labeled for that application.
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
Reported Outcomes
Safety Profile
Evidence Limitations
Practical Considerations
- The Phenom family includes different catheter configurations and sizes; compatibility with guidewires, microcatheters, implants, and other devices must be verified for the specific model.
- The catheter is advanced over a guidewire under image guidance, commonly through femoral or radial arterial access, depending on the procedure.
- Potential complications include vascular injury, dissection, perforation, thrombosis, embolization, infection, bleeding, and contrast-related complications.
- MRI safety depends on the exact model and whether the catheter remains in the patient; consult the current labeling and device-specific MRI conditions before scanning.
- The catheter should not be used when the planned access route, vessel size, device compatibility, or patient condition makes catheterization unsafe; product labeling and institutional protocols apply.
Frequently Asked Questions
What are the clinical indications for Phenom catheters?
Phenom catheters are indicated for use in neurovascular procedures, particularly for accessing and treating cerebral aneurysms.
What outcomes have been reported in clinical studies?
Studies report successful navigation and deployment in complex aneurysm cases, with effective management of challenging vascular anatomies.
What complications have been reported?
Reported complications include general procedural risks, but specific adverse events related to Phenom catheters are not detailed in the studies.