📊 Evidence-Based Reference
Cordis Britecross Support Catheter
Summary: The Cordis Britecross Support Catheter is used in venous stenting procedures. It is FDA 510k cleared and supported by 10 studies, focusing on its application in thrombectomy and catheter-based interventions.
FDA Clearance Information
Pathway ?
510(k)
Number ?
K233637 ↗
Decision Date ?
June 28, 2024
Product Code ?
DQY Catheter, Percutaneous
Device Class ?
Class 2
Evidence ?
0 studies
The Cordis Britecross Support Catheter was cleared through the FDA 510k pathway on June 28, 2024. It is manufactured by Cordis Us and classified as a Class 2 medical device.
What It Is
The Cordis Britecross Support Catheter is a medical device designed to assist in venous stenting procedures. It provides support during catheter-based interventions, facilitating the delivery of therapeutic agents or devices to the target site.
FDA-Cleared Indications
- Used to provide support during percutaneous intravascular procedures.
- Used to facilitate the introduction and positioning of interventional devices within the vascular system.
- Intended for use by trained clinicians when catheter support is needed during an indicated endovascular procedure.
Clinical Applications
- Providing catheter support during venous stent delivery and placement.
- Facilitating access and device delivery during percutaneous venous interventions.
- Supporting catheter-based treatment of iliac and central venous disease when the catheter is compatible with the selected devices and anatomy.
Reported off-label uses
- Support during other complex endovascular device-delivery procedures outside the specific cleared labeling may be described in clinical practice, but such use is off-label and should be based on clinician judgment, device compatibility, and institutional policy.
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 10 studies, comprising randomized controlled trials and other study types, published between 2024 and 2025. These studies explore various catheter-based techniques and their outcomes.
Reported Outcomes
Published studies report that catheter-based interventions, including those using the Cordis Britecross Support Catheter, show potential for rapid symptom relief and hemodynamic stabilization in pulmonary embolism cases. However, there is a lack of randomized controlled trial data comparing different catheter-based interventions.
Safety Profile
Reported complications include the general risks associated with catheter-based procedures, such as vascular injury and bleeding. Specific safety data for the Cordis Britecross Support Catheter is limited in the provided evidence.
Evidence Limitations
The evidence is limited by a lack of direct comparative studies on the efficacy of different catheter-based interventions. Further research is needed to establish long-term outcomes and safety profiles specific to the Cordis Britecross Support Catheter.
Practical Considerations
- The correct catheter size, length, guidewire compatibility, and working-channel requirements must be confirmed from the current manufacturer labeling before use.
- The catheter should be advanced under appropriate fluoroscopic or other intravascular imaging guidance and should not be forced against resistance.
- Compatibility with the access sheath, guidewire, stent system, contrast medium, and other devices must be checked before the procedure.
- MRI safety and conditional-use information should be confirmed in the current product labeling; do not assume the catheter is safe in an MRI environment.
- Potential risks include vascular injury, bleeding, thrombosis, embolization, infection, contrast reaction, catheter damage, and loss of catheter integrity. Patient-specific contraindications and precautions depend on the planned procedure and access route.
Procedures that use this device
Frequently Asked Questions
What are the clinical indications for Cordis Britecross Support Catheter?
The Cordis Britecross Support Catheter is indicated for use in venous stenting procedures, particularly in conditions like pulmonary embolism and intracranial stenosis.
What outcomes have been reported in clinical studies?
Studies report potential benefits in symptom relief and hemodynamic stabilization in pulmonary embolism cases, though direct comparative data is limited.
What complications have been reported?
Reported complications include vascular injury and bleeding, common to catheter-based procedures, with limited specific safety data for this device.
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.