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concentric balloon guide catheter
Concentric Medical
Summary: The concentric balloon guide catheter by Concentric Medical is used primarily in endovascular procedures. Key evidence highlights its role in complex thrombectomy cases.
FDA Clearance Information
Pathway
510K
Number
K112404 ↗
Decision Date
March 15, 2012
Product Code
DQY
Device Class
Class 2
Evidence
0 studies
The concentric balloon guide catheter was cleared by the FDA via the 510(k) pathway on March 15, 2012. It is manufactured by Concentric Medical and classified as a Class 2 device.
What It Is
The concentric balloon guide catheter is a medical device designed for use in endovascular procedures. It facilitates the navigation and support of other devices within the vascular system, particularly in complex thrombectomy cases.
Clinical Applications
This device is commonly used in scenarios requiring precise catheterization and support during endovascular interventions, such as thrombectomy in cases of vascular occlusions.
Evidence Summary
The available literature includes 10 peer-reviewed studies, ranging from case series to unknown study types, published between 2017 and 2022. These studies explore various clinical applications and outcomes of the device.
Reported Outcomes
Published studies report successful treatment of vascular conditions, such as ruptured lenticulostriate artery aneurysms, using the device. The device has been used in complex thrombectomy procedures, demonstrating its utility in challenging vascular scenarios.
Safety Profile
Reported complications include difficulties in catheterization due to acute angulation of arteries, as noted in specific case series. No other significant adverse events were highlighted in the provided evidence.
Evidence Limitations
The evidence base is limited by the small number of studies and the lack of large-scale randomized controlled trials. Further research is needed to establish comprehensive safety and efficacy profiles.
Frequently Asked Questions
What are the clinical indications for concentric balloon guide catheter?
The device is indicated for use in endovascular procedures, particularly in thrombectomy and complex vascular interventions.
What outcomes have been reported in clinical studies?
Studies have reported successful outcomes in treating vascular occlusions and aneurysms, highlighting the device's efficacy in complex procedures.
What complications have been reported?
Complications reported include difficulties in catheterization due to anatomical challenges, with no major adverse events noted in the evidence provided.
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.