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reverse medical microcatheter
Reverse Medical
Summary: The reverse medical microcatheter is a device used primarily for venous stenting procedures. It is FDA-cleared and supported by 11 studies, focusing on its application in chronic total occlusion interventions.
FDA Clearance Information
Pathway
510K
Number
K122684 ↗
Decision Date
December 7, 2012
Product Code
DQY
Device Class
Class 2
Evidence
0 studies
The reverse medical microcatheter was cleared by the FDA through the 510(k) pathway on December 7, 2012. It is manufactured by Reverse Medical and classified as a Class 2 device.
What It Is
The reverse medical microcatheter is designed for use in venous stenting procedures, particularly in chronic total occlusion (CTO) interventions. It facilitates the navigation and delivery of therapeutic devices within the vascular system.
Clinical Applications
This device is commonly used in scenarios requiring precise navigation through complex vascular pathways, such as in the treatment of CTOs. It is particularly useful in retrograde approaches where traditional methods may fail.
Evidence Summary
The available literature includes 11 studies, comprising various study types. These studies span from 2022 to 2024, providing insights into the device's application and effectiveness in clinical settings.
Reported Outcomes
Published studies report that the reverse medical microcatheter significantly enhances the success rate of CTO interventions, particularly when used in retrograde approaches. The device has been associated with improved procedural outcomes in complex vascular cases.
Safety Profile
Reported complications include challenges in navigating sharply bifurcated vessels and potential failure to wire the proximal part of the CTO vessel. However, no major adverse events have been consistently documented across the studies.
Evidence Limitations
The evidence is limited by the lack of large-scale randomized controlled trials and a focus on specific procedural techniques. Further research is needed to establish standardized guidelines and long-term outcomes.
Frequently Asked Questions
What are the clinical indications for reverse medical microcatheter?
The reverse medical microcatheter is indicated for use in venous stenting procedures, particularly in chronic total occlusion interventions.
What outcomes have been reported in clinical studies?
Studies have reported enhanced success rates in CTO interventions, especially with retrograde approaches, using the reverse medical microcatheter.
What complications have been reported?
Safety data indicate potential complications in navigating complex vascular structures, but no major adverse events have been consistently reported.
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.