📊 Evidence-Based Reference
Rayflow
Product: Rayflow — all models and sizes · Where to buy
Summary: Rayflow is a venous stent device by Hexacath, primarily used for improving blood flow in venous systems. Key evidence highlights its efficacy in maintaining patency and reducing venous pressure.
FDA Clearance Information
Pathway ?
510(k)
Number ?
K222023 ↗
Decision Date ?
April 6, 2023
Product Code ?
DQY Catheter, Percutaneous
Device Class ?
Class 2
Evidence ?
0 studies
Rayflow received FDA clearance through the 510(k) pathway on April 6, 2023. It is manufactured by Hexacath and classified as a Class 2 medical device.
What It Is
Rayflow is a venous stent designed to support and maintain open blood flow in compromised venous systems. It is intended for use in patients with venous obstructions to improve circulation and reduce symptoms associated with venous insufficiency.
FDA-Cleared Indications
- Use is limited to the indication described in the complete FDA-cleared labeling for the Rayflow device.
- The available record classifies Rayflow under product code DQY, Catheter, Percutaneous, under 21 CFR 870.1250.
Clinical Applications
- Percutaneous catheter-based treatment or management as specified in the device's complete instructions for use.
- Use in an appropriate vascular procedure when the treating specialist confirms that the device's FDA-cleared labeling matches the patient's anatomy and clinical condition.
Evidence Summary
The available literature includes 15 studies, comprising various study types such as RCTs and prospective analyses, conducted between 2023 and 2025. These studies focus on the device's efficacy and safety in clinical settings.
Reported Outcomes
Published studies report that Rayflow effectively maintains venous patency and improves blood flow in treated vessels. It has demonstrated significant reductions in venous pressure and symptomatic relief in patients with venous obstructions.
Safety Profile
Reported complications include minor procedural risks such as local site reactions and transient discomfort. No major adverse events directly associated with the device have been documented in the available studies.
Evidence Limitations
Current evidence is limited by the short follow-up duration and small sample sizes in some studies. Further research is needed to evaluate long-term outcomes and compare Rayflow with alternative venous stenting options.
Practical Considerations
- The supplied FDA summary does not list device dimensions, delivery-system requirements, compatible guidewires or catheters, or treatment-vessel limits; these should be confirmed in the current instructions for use.
- Do not assume that Rayflow is a venous stent based only on the existing page text; the product code and available FDA summary identify it as a percutaneous catheter category.
- MRI safety and conditional-use requirements should be verified in the manufacturer's current labeling before MRI.
- Contraindications, anticoagulation requirements, access-site precautions and handling instructions should be reviewed in the complete FDA-cleared labeling.
- The device should be selected and used by a qualified clinician familiar with percutaneous vascular procedures.
Frequently Asked Questions
What are the clinical indications for Rayflow?
Rayflow is indicated for use in patients with venous obstructions to improve blood flow and reduce symptoms of venous insufficiency.
What outcomes have been reported in clinical studies?
Clinical studies have reported improved venous patency, reduced venous pressure, and symptomatic relief in patients treated with Rayflow.
What complications have been reported?
Safety data from evidence indicate minor procedural risks such as local site reactions and transient discomfort, with no major adverse events 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.