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bobby balloon guide catheter
Microvention
Summary: The Bobby Balloon Guide Catheter is a device used in endovascular procedures, primarily for mechanical thrombectomy in ischemic stroke. Key evidence suggests improved technical and functional outcomes with its use.
FDA Clearance Information
Pathway
510K
Number
K193607 ↗
Decision Date
July 21, 2020
Product Code
DQY
Device Class
Class 2
Evidence
0 studies
The Bobby Balloon Guide Catheter was cleared by the FDA via the 510(k) pathway on July 21, 2020. It is manufactured by Microvention and is classified as a Class 2 device.
What It Is
The Bobby Balloon Guide Catheter is a medical device designed to assist in endovascular procedures by providing a stable platform for catheter navigation. It is primarily used in mechanical thrombectomy for acute ischemic stroke.
Clinical Applications
Commonly used in the treatment of acute ischemic stroke, the Bobby Balloon Guide Catheter facilitates the removal of thrombi from large vessels. It is particularly useful in scenarios requiring enhanced control and stability during catheterization.
Evidence Summary
The literature includes six studies, comprising randomized controlled trials and observational studies, focusing on the use of balloon guide catheters in stroke treatment. These studies span from 2024 and earlier, providing a range of clinical insights.
Reported Outcomes
Published studies report that the use of the Bobby Balloon Guide Catheter in mechanical thrombectomy is associated with improved technical and functional outcomes compared to conventional guide catheters. These findings highlight its compatibility with large-bore catheters and potential benefits in stroke management.
Safety Profile
Reported complications include device-related issues typical of endovascular procedures, though specific adverse events were not detailed in the provided studies. Overall, the safety profile appears consistent with similar devices in its class.
Evidence Limitations
The evidence is limited by a lack of large-scale randomized controlled trials and detailed safety data. Further research is needed to fully understand the long-term outcomes and potential complications associated with its use.
Frequently Asked Questions
What are the clinical indications for Bobby Balloon Guide Catheter?
The device is indicated for use in endovascular procedures, particularly mechanical thrombectomy in acute ischemic stroke.
What outcomes have been reported in clinical studies?
Studies have reported improved technical and functional outcomes with the use of the Bobby Balloon Guide Catheter in thrombectomy procedures.
What complications have been reported?
Reported complications include general device-related issues, but specific adverse events were not detailed in the available studies.
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.