đź“Š Evidence-Based Reference
reverse medical report guide catheter system
Reverse Medical
Summary: The reverse medical report guide catheter system by Reverse Medical is a Class 2 device cleared by the FDA for use in venous-stents. Key evidence highlights its application in coronary and neuroendovascular procedures.
FDA Clearance Information
Pathway
510K
Number
K102418 ↗
Decision Date
April 15, 2011
Product Code
DQY
Device Class
Class 2
Evidence
0 studies
The reverse medical report guide catheter system was cleared by the FDA through the 510(k) pathway on April 15, 2011. It is manufactured by Reverse Medical and classified as a Class 2 device.
What It Is
The reverse medical report guide catheter system is designed for use in venous-stent procedures. It facilitates the delivery of stents and other therapeutic devices to target sites within the vascular system.
Clinical Applications
Commonly used in coronary and neuroendovascular procedures, this catheter system aids in the placement of stents and other devices, particularly in cases requiring precise navigation through the vascular system.
Evidence Summary
The available literature includes 11 studies, comprising RCTs, case series, and other study types, published between 2024 and 2026. These studies explore various applications and outcomes of the catheter system.
Reported Outcomes
Published studies report the catheter system's effectiveness in facilitating coronary and neuroendovascular procedures. It has been utilized in carotid artery stenting and managing radial artery perforations, demonstrating its versatility in complex vascular interventions.
Safety Profile
Reported complications include radial artery perforation and potential hematoma formation, particularly in patients on multiple antithrombotic agents. These complications are generally managed with external compression and anticoagulation reversal.
Evidence Limitations
The evidence is limited by the small sample sizes and the retrospective nature of some studies. Further research is needed to establish long-term outcomes and safety profiles in diverse patient populations.
Frequently Asked Questions
What are the clinical indications for reverse medical report guide catheter system?
The device is indicated for use in venous-stent procedures, particularly in coronary and neuroendovascular interventions.
What outcomes have been reported in clinical studies?
Studies have reported successful use in coronary and neuroendovascular procedures, including carotid artery stenting and management of radial artery perforations.
What complications have been reported?
Safety data indicate complications such as radial artery perforation and hematoma, managed with external compression and anticoagulation reversal.
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.