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chaperon guiding catheter
Microvention
Summary: The Chaperon Guiding Catheter by Microvention is a Class 2 device cleared by the FDA for use in venous stents. Key evidence includes case reports and technical notes on its application in complex procedures.
FDA Clearance Information
Pathway 510K
Number K082385 ↗
Decision Date December 11, 2008
Product Code DQY
Device Class Class 2
Evidence 0 studies
The Chaperon Guiding Catheter was cleared through the FDA 510(k) pathway on December 11, 2008. It is manufactured by Microvention and classified as a Class 2 device.
What It Is
The Chaperon Guiding Catheter is designed to facilitate the delivery of therapeutic devices in venous stenting procedures. It provides support and guidance for the placement of stents in complex vascular anatomies.
Clinical Applications
Commonly used in procedures requiring precise navigation and support in venous stenting, the Chaperon Guiding Catheter is particularly useful in cases with challenging vascular access or tortuous anatomy.
Evidence Summary
The available literature includes case reports and technical notes, with studies ranging from 2004 to 2023. These studies explore various applications and techniques involving the guiding catheter.
Reported Outcomes
Published studies report successful use of the Chaperon Guiding Catheter in complex vascular procedures, including transcatheter aortic valve replacement and intracranial aneurysm treatment. The device has been shown to facilitate effective delivery of therapeutic devices.
Safety Profile
Reported complications include potential issues related to vascular access and navigation in complex anatomies. However, specific adverse events related to the catheter itself are not extensively documented in the provided evidence.
Evidence Limitations
The evidence is limited by the small number of studies and the focus on case reports and technical notes. Further research is needed to establish comprehensive safety and efficacy profiles across diverse patient populations.
Frequently Asked Questions
What are the clinical indications for Chaperon Guiding Catheter?
The Chaperon Guiding Catheter is indicated for use in venous stenting procedures, particularly in complex vascular anatomies.
What outcomes have been reported in clinical studies?
Clinical studies have reported successful navigation and support in complex procedures, such as TAVR and intracranial aneurysm treatment.
What complications have been reported?
Reported complications include challenges with vascular access and navigation, though specific adverse events related to the catheter are not well-documented.
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.