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8f flowgate2 balloon guide catheter
Concentric Medical
Summary: The 8f Flowgate2 balloon guide catheter is used in mechanical thrombectomy for acute ischemic stroke. Key evidence highlights its feasibility in transradial approaches.
FDA Clearance Information
Pathway
510K
Number
K153729 ↗
Decision Date
January 27, 2016
Product Code
DQY
Device Class
Class 2
Evidence
0 studies
The 8f Flowgate2 balloon guide catheter was cleared by the FDA via the 510(k) pathway on January 27, 2016. It is manufactured by Concentric Medical and classified as a Class 2 device.
What It Is
The 8f Flowgate2 is a balloon guide catheter designed to assist in mechanical thrombectomy procedures by providing flow arrest. It is intended for use in patients with acute ischemic stroke due to large vessel occlusion.
Clinical Applications
Commonly used in endovascular thrombectomy procedures, the 8f Flowgate2 is particularly beneficial in cases where flow arrest is necessary to improve reperfusion rates. It is suitable for both transfemoral and transradial approaches.
Evidence Summary
The literature includes two studies, published between 2022 and 2023, examining the use of balloon guide catheters in mechanical thrombectomy. These studies explore the device's feasibility and safety in clinical settings.
Reported Outcomes
Published studies report that the use of balloon guide catheters, such as the 8f Flowgate2, can increase the rate of reperfusion during mechanical thrombectomy. The device's compatibility with large bore aspiration catheters and its flexibility are noted as advantages.
Safety Profile
Reported complications include challenges with vascular anatomy during transfemoral approaches. However, the studies highlight the device's feasibility and safety in transradial use.
Evidence Limitations
The current evidence is limited by small sample sizes and a lack of randomized controlled trials. Further research is needed to fully understand the long-term outcomes and comparative effectiveness of different access approaches.
Frequently Asked Questions
What are the clinical indications for 8f Flowgate2 balloon guide catheter?
The device is indicated for use in mechanical thrombectomy procedures for patients with acute ischemic stroke due to large vessel occlusion.
What outcomes have been reported in clinical studies?
Studies report increased reperfusion rates and compatibility with large bore aspiration catheters as key outcomes.
What complications have been reported?
Complications include challenges with vascular anatomy in transfemoral approaches, though transradial use is feasible and safe.
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.