đź“Š Evidence-Based Reference
modified balloon guide catheter model 90253 90254
Concentric Medical
Summary: The modified balloon guide catheter by Concentric Medical is used in endovascular procedures, primarily for acute ischemic stroke. Key evidence suggests it may improve clinical outcomes compared to standard guide catheters.
FDA Clearance Information
Pathway
510K
Number
K122581 ↗
Decision Date
November 21, 2012
Product Code
DQY
Device Class
Class 2
Evidence
0 studies
The modified balloon guide catheter was cleared by the FDA through the 510(k) pathway on November 21, 2012. It is manufactured by Concentric Medical and classified as a Class 2 device.
What It Is
The modified balloon guide catheter is a medical device designed to assist in endovascular procedures by providing flow arrest and facilitating clot retrieval. It is primarily used in the treatment of acute ischemic stroke.
Clinical Applications
This device is commonly used in mechanical thrombectomy procedures for acute ischemic stroke. It is employed to improve clot retrieval efficiency and enhance reperfusion outcomes.
Evidence Summary
The literature includes 11 studies, comprising randomized controlled trials, systematic reviews, and meta-analyses, conducted between 2016 and 2025. These studies evaluate the efficacy and cost-effectiveness of balloon guide catheters.
Reported Outcomes
Published studies report that the use of balloon guide catheters is associated with improved clinical and angiographic outcomes compared to standard guide catheters in acute ischemic stroke treatment. They may also reduce procedure duration, which is linked to better patient outcomes.
Safety Profile
Reported complications include potential risks associated with endovascular procedures, such as vascular injury or device-related complications. However, specific safety data from the provided studies are limited.
Evidence Limitations
The evidence is limited by the variability in study designs and the lack of long-term outcome data. Further research is needed to confirm cost-effectiveness and to explore potential complications in diverse patient populations.
Frequently Asked Questions
What are the clinical indications for modified balloon guide catheter?
The device is indicated for use in mechanical thrombectomy procedures for acute ischemic stroke to improve clot retrieval and reperfusion outcomes.
What outcomes have been reported in clinical studies?
Studies report improved clinical and angiographic outcomes with balloon guide catheters compared to standard guide catheters in stroke treatment.
What complications have been reported?
Reported complications include risks inherent to endovascular procedures, such as vascular injury, though specific safety data are limited.
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.