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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
510K
Number
K102657 ↗
Decision Date
November 17, 2010
Product Code
DQY
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.
Clinical Applications
This device is commonly used in neurovascular procedures, such as thrombectomy, where it aids in the removal of thrombus from blood vessels. It is particularly useful in complex cases where direct access to the target site is challenging.
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.
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.