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coraforce and coraflex support catheters
Reflow Medical
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
510K
Number
K201811 ↗
Decision Date
October 26, 2020
Product Code
DQY
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.
Clinical Applications
These catheters are commonly used in clinical scenarios involving venous stenting, particularly in patients with venous obstructions requiring intervention. They are integral in procedures aimed at restoring venous flow and reducing symptoms associated with venous insufficiency.
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.
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.