📊 Evidence-Based Reference
087 Balloon Guide Catheter System
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 ?
510(k)
Number ?
K192525 ↗
Decision Date ?
October 31, 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 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.
FDA-Cleared Indications
- Used for the percutaneous introduction of interventional and diagnostic devices into the peripheral, coronary, and neurovascular vasculature.
- Intended to provide a conduit for the delivery of compatible devices and contrast media during vascular procedures.
- The FDA product classification identifies it as a percutaneous catheter; the available FDA summary does not establish a disease-specific indication beyond this catheter function.
Clinical Applications
- Percutaneous vascular access and catheter-based delivery of compatible interventional devices.
- Use as a large-bore conduit during endovascular procedures requiring controlled catheter access.
- Delivery of contrast media for angiographic imaging when the catheter and procedure are compatible.
- Use in neurovascular procedures when the specific device configuration, anatomy, and procedure are consistent with the cleared labeling.
Reported off-label uses
- Balloon-assisted flow arrest or flow reversal during selected neurointerventional procedures, when performed under appropriate specialist judgment.
- Adjunctive proximal control during selected endovascular thrombectomy procedures.
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, 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.
Practical Considerations
- The catheter has a nominal 0.087-inch inner diameter; the treating team must confirm compatibility with the guidewire, aspiration catheter, microcatheter, stent-retriever system, and access sheath.
- Balloon inflation requires careful sizing to the target vessel and monitoring to reduce the risk of vessel injury, dissection, ischemia, or balloon rupture.
- Use requires fluoroscopic or other appropriate imaging guidance and standard precautions for percutaneous vascular catheterization.
- MRI safety depends on the exact device configuration and labeling. The catheter should not be taken into an MRI environment unless its current labeling confirms the conditions for MR use.
- Potential complications include bleeding or hematoma at the access site, thrombosis, embolization, vessel injury, infection, contrast reaction, and neurologic or ischemic complications.
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.