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087 balloon guide catheter system
Q'Apel Medical
Summary: The 087 balloon guide catheter system by Q'Apel Medical is used in acute stroke treatment to improve recanalization. Key evidence highlights its large bore design for optimized outcomes.
FDA Clearance Information
Pathway
510K
Number
K192525 ↗
Decision Date
October 31, 2019
Product Code
DQY
Device Class
Class 2
Evidence
0 studies
The 087 balloon guide catheter system was cleared by the FDA through the 510(k) pathway on October 31, 2019. It is manufactured by Q'Apel Medical and classified as a Class 2 device.
What It Is
The 087 balloon guide catheter system is a medical device designed to assist in acute stroke treatment by facilitating recanalization. It features a large bore 0.087 inch inner diameter for improved blood flow management.
Clinical Applications
Commonly used in the context of acute ischemic stroke, the device aids in procedures requiring vascular access and management, particularly where rapid recanalization is critical.
Evidence Summary
The available literature includes two studies, with one focusing on the Walrus BGC's impact on recanalization and outcomes. These studies span from 2010 to 2022 and include various study types.
Reported Outcomes
Published studies report that the use of the Walrus BGC in acute stroke treatment has been associated with improved recanalization and procedure metrics. The large bore design is noted for its potential to enhance first pass effect outcomes.
Safety Profile
Reported complications include technical constraints related to catheter stiffness and smaller inner diameters in earlier devices. However, specific adverse events were not detailed in the provided studies.
Evidence Limitations
The evidence is limited by the small number of studies and lack of detailed safety outcomes. Further research is needed to fully understand the long-term efficacy and safety profile of the device.
Frequently Asked Questions
What are the clinical indications for 087 balloon guide catheter system?
The device is indicated for use in acute ischemic stroke to facilitate recanalization and improve procedural outcomes.
What outcomes have been reported in clinical studies?
Studies have reported improved recanalization and first pass effect outcomes with the use of the device.
What complications have been reported?
Reported complications include issues with catheter stiffness and diameter in earlier devices, though specific adverse events were not detailed.
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.