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Coraforce and Coraflex Support Catheters
Summary: The coraforce and coraflex support catheters by Reflow Medical are used in venous stenting procedures. They were FDA-cleared via the 510(k) pathway in 2020. Key evidence highlights their role in reducing infection risks when used with care bundles.
FDA Clearance Information
Pathway ?
510(k)
Number ?
K201811 ↗
Decision Date ?
October 26, 2020
Product Code ?
DQY Catheter, Percutaneous
Device Class ?
Class 2
Evidence ?
0 studies
The coraforce and coraflex support catheters were cleared by the FDA through the 510(k) pathway on October 26, 2020. Manufactured by Reflow Medical, these devices are classified as Class 2 under product code DQY.
What It Is
The coraforce and coraflex support catheters are medical devices designed to facilitate venous stenting procedures. They provide support and access during the placement of stents in venous systems, aiding in the treatment of venous obstructions.
FDA-Cleared Indications
- Percutaneous catheter use for intravascular access and support during vascular procedures, consistent with product code DQY.
- Use as an accessory catheter to facilitate the delivery or positioning of other devices during an indicated vascular intervention.
Clinical Applications
- Providing catheter support during venous stent delivery and placement when consistent with the device labeling.
- Facilitating access through the venous system during endovascular treatment of venous obstruction.
- Supporting delivery of compatible interventional devices during percutaneous vascular procedures.
Evidence Summary
The available literature includes 10 studies, comprising various study types such as RCTs, prospective, and retrospective analyses. These studies span a publication date range up to 2024, providing insights into the clinical efficacy and safety of the catheters.
Reported Outcomes
Published studies report that the use of coraforce and coraflex support catheters in conjunction with care bundles can lead to decreased infection rates. The studies emphasize the importance of bundled strategies in reducing complications associated with vascular access devices.
Safety Profile
Reported complications include infection risks comparable to those of short-term, non-cuffed central venous catheters. However, the use of care bundles has been shown to mitigate these risks effectively.
Evidence Limitations
The evidence is limited by the lack of large-scale randomized controlled trials specifically focusing on these catheters. Further research is needed to explore long-term outcomes and to validate the findings across diverse patient populations.
Practical Considerations
- Use only with the catheter sizes, guidewires, introducer sheaths, and other devices specified in the current manufacturer instructions for use.
- The treating physician should confirm vessel size, access route, device compatibility, and the catheter's rated pressure and other performance limits before use.
- The available FDA record does not establish a general MRI safety designation; MRI conditions should be confirmed in the current labeling or with the manufacturer.
- Potential catheter-related complications include vascular injury, bleeding, thrombosis, embolization, infection, and device malfunction.
- Contraindications, warnings, and handling requirements should be taken from the current instructions for use rather than inferred from the product code alone.
Procedures that use this device
Frequently Asked Questions
What are the clinical indications for coraforce and coraflex support catheters?
These catheters are indicated for use in venous stenting procedures, particularly in cases of venous obstructions.
What outcomes have been reported in clinical studies?
Studies have reported decreased infection rates when used with care bundles, highlighting their efficacy in reducing vascular access complications.
What complications have been reported?
Safety data indicate infection risks similar to other vascular access devices, but these can be reduced with proper care strategies.
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.