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Reverse Medical Microcatheter
Product: ReverseTM — all models and sizes
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 ?
510(k)
Number ?
K122684 ↗
Decision Date ?
December 7, 2012
Product Code ?
DQY Catheter, Percutaneous
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.
FDA-Cleared Indications
- Used for percutaneous catheter-based access to blood vessels during diagnostic or therapeutic procedures.
- Intended to facilitate navigation through the vascular system and support delivery of compatible interventional devices.
- FDA classification: Class II percutaneous catheter, product code DQY, under 21 CFR 870.1250.
Clinical Applications
- Percutaneous catheter-based vascular procedures requiring selective vessel navigation.
- Support for delivery or exchange of compatible guidewires and interventional devices.
- Navigation through complex vascular anatomy when a small, flexible catheter is needed.
- Use during venous interventions when the device is compatible with the planned procedure and access system.
Reported off-label uses
- Use in selected chronic total occlusion interventions, including retrograde crossing techniques, when performed by experienced clinicians.
- Use in complex venous recanalization or stenting workflows beyond the specific indications described in the device labeling.
Off-label use: these uses are reported in practice or the literature but are not part of the FDA-cleared indications. Physicians may use a cleared device off-label based on their medical judgment; the manufacturer may not promote off-label uses.
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.
Practical Considerations
- The record provided does not specify the catheter's available lengths, outer diameters, inner diameters, or maximum guidewire compatibility; clinicians should confirm these details in the current instructions for use.
- Compatibility with guidewires, introducer sheaths, stents, thrombectomy systems, contrast agents, and other devices must be checked before use.
- The device is navigated under fluoroscopic or other appropriate vascular imaging guidance and should be handled carefully to reduce the risk of kinking, vessel injury, dissection, perforation, thrombosis, or embolization.
- MRI safety is not established by the information provided. The current device labeling should be reviewed for MR Safe, MR Conditional, or MR Unsafe status before an MRI examination.
- As with other vascular catheters, use may be inappropriate in patients with an unsuitable access vessel, uncontrolled bleeding risk, severe contrast allergy when contrast is required, or another contraindication identified by the treating clinician.
Procedures that use this device
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.