đź“Š Evidence-Based Reference
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 ?
510(k)
Number ?
K190749 ↗
Decision Date ?
July 15, 2019
Product Code ?
DQY Catheter, Percutaneous
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.
FDA-Cleared Indications
- Percutaneous catheter use within the vascular system as described in the FDA-cleared labeling.
- Use is limited to the indications, anatomy, and procedural conditions specified in the current manufacturer’s instructions for use.
Clinical Applications
- Use as a large-bore access catheter during an appropriately labeled endovascular procedure.
- Use when catheter flexibility and variable shaft stiffness are required for navigation within the vascular system.
- Use in procedures involving venous access only when supported by the current FDA-cleared labeling and instructions for use.
Reported off-label uses
- Balloon guide catheter use for proximal flow control or flow arrest during neurointerventional thrombectomy has been described for this device category, but this application should not be assumed to be cleared for this specific device.
- Use during complex venous recanalization or thrombectomy procedures may occur in clinical practice, but the treating physician must verify device-specific labeling and institutional requirements.
Off-label use: these uses are reported in practice or the literature but are not part of the FDA-cleared indications. Physicians may use a cleared device off-label based on their medical judgment; the manufacturer may not promote off-label uses.
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.
Practical Considerations
- The system has a reported 0.087-inch inner diameter and variable stiffness; users should confirm compatibility with guidewires, introducer sheaths, aspiration systems, and other equipment before use.
- The supplied FDA record identifies the product code as DQY, Catheter, Percutaneous, under 21 CFR 870.1250. The summary does not provide complete device-specific contraindications or anatomic limitations.
- Balloon inflation, if applicable to the labeled configuration, requires strict adherence to the manufacturer’s instructions for inflation volume, pressure, and compatible media.
- MRI safety is not established by the information supplied here. Review the current labeling for MR Safe, MR Conditional, or MR Unsafe status before MRI.
- Potential catheter risks include vascular injury, bleeding, thrombosis, embolization, infection, dissection, perforation, and device malfunction. Contraindications and warnings should be taken from the current instructions for use.
Procedures that use this device
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.