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phenom catheters
Micro Therapeutics Lnc. D/B/A Ev3 Neurovascular
Summary: Phenom catheters are used in neurovascular interventions, primarily for accessing distal cerebral arteries. Key evidence highlights their role in complex aneurysm management.
FDA Clearance Information
Pathway
510K
Number
K210230 ↗
Decision Date
February 25, 2021
Product Code
DQY
Device Class
Class 2
Evidence
0 studies
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
Phenom catheters are distal access catheters designed for neurovascular procedures. They facilitate the navigation and deployment of devices in complex vascular anatomies, particularly in the cerebral arteries.
Clinical Applications
Commonly used in the management of cerebral aneurysms, Phenom catheters assist in the placement of flow diverters and other neurovascular interventions. They are particularly useful in challenging vascular anatomies.
Evidence Summary
The literature includes case studies and series from 2020 to 2025, focusing on the use of Phenom catheters in neurovascular procedures. The studies explore various access techniques and procedural outcomes.
Reported Outcomes
Published studies report successful use of Phenom catheters in complex aneurysm cases, with advantages in procedural navigation and device deployment. The evidence suggests effective management of challenging vascular conditions.
Safety Profile
Reported complications include typical procedural risks associated with neurovascular interventions, such as access site complications. However, specific adverse events related to Phenom catheters are not detailed in the provided studies.
Evidence Limitations
The evidence is limited by the small number of studies and lack of large-scale randomized trials. Further research is needed to establish long-term outcomes and safety profiles of Phenom catheters.
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.
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.