đź“Š Evidence-Based Reference
micro rx
Imds Operations
Summary: The micro rx is a rapid exchange microcatheter designed to aid in guidewire support during percutaneous coronary interventions. It is primarily used in complex coronary lesions. Key evidence highlights its effectiveness in improving guidewire steerability.
FDA Clearance Information
Pathway
510K
Number
K223728 ↗
Decision Date
July 13, 2023
Product Code
DQY
Device Class
Class 2
Evidence
0 studies
The micro rx received FDA clearance through the 510(k) pathway on July 13, 2023. It is manufactured by Imds Operations and classified as a Class 2 device.
What It Is
The micro rx is a rapid exchange microcatheter that enhances guidewire support and steerability in percutaneous coronary interventions. It is intended for use in navigating tortuous and calcified coronary lesions.
Clinical Applications
The micro rx is commonly used in percutaneous coronary interventions, particularly in cases involving complex coronary anatomy such as tortuous or heavily calcified lesions. It aids in the successful crossing of target lesions with a guidewire.
Evidence Summary
The available literature includes 15 studies, comprising various study types such as RCTs and case series, with publication years ranging from 2023 to 2025. These studies provide insights into the device's clinical performance and safety.
Reported Outcomes
Published studies report that the micro rx improves guidewire steerability and penetration force in challenging coronary lesions. It has been shown to facilitate successful crossing of target lesions, thereby enhancing procedural success rates.
Safety Profile
Reported complications include increased procedural costs and the need for specific training to use the device effectively. No significant adverse events directly attributed to the device have been documented in the available studies.
Evidence Limitations
The evidence is limited by the small number of studies directly evaluating the micro rx. Further research is needed to assess long-term outcomes and to compare its performance with other similar devices.
Frequently Asked Questions
What are the clinical indications for micro rx?
The micro rx is indicated for use in percutaneous coronary interventions, particularly in complex coronary lesions such as tortuous or heavily calcified arteries.
What outcomes have been reported in clinical studies?
Clinical studies have reported improved guidewire steerability and penetration force, facilitating successful lesion crossing and enhancing procedural success rates.
What complications have been reported?
Reported complications include increased procedural costs and the requirement for specific training. No significant adverse events directly related to the device have been 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.