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087 balloon guide catheter system
Q'Apel
Summary: The 087 balloon guide catheter system by Q'Apel is used in venous stenting procedures. It was FDA cleared via the 510k pathway in 2019. Key evidence highlights its impact on recanalization and procedural outcomes.
FDA Clearance Information
Pathway
510K
Number
K190749 ↗
Decision Date
July 15, 2019
Product Code
DQY
Device Class
Class 2
Evidence
0 studies
The 087 balloon guide catheter system was cleared by the FDA through the 510k pathway on July 15, 2019. Manufactured by Q'Apel, it is classified as a Class 2 device.
What It Is
The 087 balloon guide catheter system is a medical device designed for use in venous stenting procedures. It features a large bore 0.087 inch inner diameter and variable stiffness, facilitating improved procedural outcomes.
Clinical Applications
This device is commonly used in acute stroke treatment to optimize recanalization and procedural metrics. It is particularly useful in scenarios requiring large bore access and enhanced catheter flexibility.
Evidence Summary
The available literature includes two studies, one from 2022 and another from 2010. The studies encompass various methodologies, including RCTs and other observational designs, focusing on the device's performance and safety.
Reported Outcomes
Published studies report that the use of the 087 balloon guide catheter system in acute stroke treatment has shown improved recanalization rates and procedural efficiency. The WICkED study specifically highlights its impact on achieving first pass effect.
Safety Profile
Reported complications include technical constraints related to catheter stiffness and smaller inner diameters in previous devices. However, the 087 system's design aims to mitigate these issues, although specific adverse events were not detailed in the provided studies.
Evidence Limitations
The evidence is limited by the small number of studies and a lack of detailed safety outcomes. Further research is needed to fully understand the long-term safety and efficacy of the device in diverse clinical settings.
Frequently Asked Questions
What are the clinical indications for 087 balloon guide catheter system?
The device is indicated for use in venous stenting procedures, particularly in acute stroke treatment to optimize recanalization.
What outcomes have been reported in clinical studies?
Studies have reported improved recanalization rates and procedural efficiency, particularly achieving first pass effect in acute stroke treatment.
What complications have been reported?
Reported complications include technical constraints such as catheter stiffness, although specific adverse events were not detailed in the studies 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.