📊 Evidence-Based Reference
Concentric Balloon Guide Catheter
Concentric Medical
Summary: The concentric balloon guide catheter is a device used primarily in endovascular procedures for vascular access and support. Key evidence highlights its use in complex thrombectomy cases.
FDA Clearance Information
Pathway ?
510(k)
Number ?
K102657 ↗
Decision Date ?
November 17, 2010
Product Code ?
DQY Catheter, Percutaneous
Device Class ?
Class 2
Evidence ?
0 studies
The concentric balloon guide catheter was cleared by the FDA through the 510(k) pathway on November 17, 2010. It is manufactured by Concentric Medical and classified as a Class 2 device.
What It Is
The concentric balloon guide catheter is designed to provide vascular access and support during endovascular procedures. It is used to facilitate the delivery of therapeutic devices and is intended for use in neurovascular and peripheral vascular interventions.
FDA-Cleared Indications
- Provides vascular access and support for the introduction of interventional devices into the peripheral and neurovascular systems.
- Is intended for use during endovascular procedures requiring catheter-based access to blood vessels.
- The specific cleared indication depends on the complete device labeling and instructions for use.
Clinical Applications
- Endovascular access and support during selected neurovascular interventions.
- Endovascular access and support during selected peripheral vascular interventions.
- Temporary balloon occlusion or flow control when specified by the device labeling and procedure plan.
- Delivery or exchange support for compatible therapeutic catheters and devices.
Reported off-label uses
- Proximal flow arrest and aspiration support during mechanical thrombectomy for acute ischemic stroke, when used outside the exact indications in the device labeling.
- Temporary flow control during complex venous thrombectomy or other peripheral endovascular procedures when the use is not specifically included in the 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 10 peer-reviewed studies, comprising case series and other study types, published between 2017 and 2022. These studies explore various clinical applications and outcomes of the device.
Reported Outcomes
Published studies report successful use of the concentric balloon guide catheter in complex thrombectomy procedures, such as retrograde thrombectomy of the basilar artery. Another study highlighted its role in the successful treatment of a ruptured lenticulostriate artery aneurysm.
Safety Profile
Reported complications include difficulties in catheterization due to acute angulation, as noted in a case involving selective catheterization of the lenticulostriate artery. No other significant adverse events were detailed in the provided evidence.
Evidence Limitations
The evidence is limited by the small number of studies and the lack of large-scale randomized controlled trials. Further research is needed to establish long-term safety and efficacy across diverse patient populations.
Practical Considerations
- The catheter must be matched to the target vessel, guidewire, sheath, and therapeutic device by diameter, length, and compatibility.
- Balloon inflation requires careful monitoring of the recommended inflation medium, volume, pressure, and vessel diameter; overinflation can injure the vessel or rupture the balloon.
- Use fluoroscopic or other appropriate imaging guidance, with attention to vessel tortuosity, spasm, dissection, thrombus, and difficult access.
- MRI safety is model-specific. Confirm the exact device's MR Safe, MR Conditional, or MR Unsafe status before MRI; do not assume all balloon guide catheters have the same classification.
- Potential complications include bleeding or hematoma at the access site, vessel injury, thrombosis, embolization, infection, balloon rupture, and complications related to contrast or sedation.
Procedures that use this device
Frequently Asked Questions
What are the clinical indications for concentric balloon guide catheter?
The device is indicated for use in neurovascular and peripheral vascular interventions, particularly in thrombectomy procedures.
What outcomes have been reported in clinical studies?
Studies have reported successful outcomes in complex thrombectomy cases and aneurysm treatments using the device.
What complications have been reported?
Safety data indicate complications such as difficult catheterization due to vessel anatomy, but no major adverse events were 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.