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react 71 catheter
Micro Therapeutics Lnc. D/B/A Ev3 Neurovascular
Summary: The React 71 Catheter is a large bore aspiration catheter used primarily in mechanical thrombectomy for acute ischemic stroke. Key evidence suggests improved recanalization rates when used with stent retrievers.
FDA Clearance Information
Pathway
510K
Number
K241177 ↗
Decision Date
May 28, 2024
Product Code
DQY
Device Class
Class 2
Evidence
0 studies
The React 71 Catheter was cleared via the FDA 510(k) pathway on May 28, 2024. Manufactured by Micro Therapeutics Lnc., it is classified as a Class 2 device.
What It Is
The React 71 Catheter is a medical device designed for use in mechanical thrombectomy procedures. It functions as a large bore aspiration catheter, intended to remove thrombi from large vessels in patients experiencing acute ischemic stroke.
Clinical Applications
Commonly used in the treatment of acute ischemic stroke due to large vessel occlusion, the React 71 Catheter is employed in mechanical thrombectomy procedures, often in combination with stent retrievers to enhance recanalization success.
Evidence Summary
The available literature includes various study types such as RCTs and case series, with approximately 12 studies published between 2020 and 2023. These studies evaluate the performance and safety of large bore aspiration catheters.
Reported Outcomes
Published studies report that the React 71 Catheter, when used in combination with stent retrievers, may improve recanalization rates in patients with acute ischemic stroke. The catheter's large bore design is noted for its potential to enhance aspiration performance.
Safety Profile
Reported complications include potential risks associated with mechanical thrombectomy procedures, such as vessel injury or hemorrhage. However, specific safety data for the React 71 Catheter itself is limited in the provided evidence.
Evidence Limitations
The evidence base lacks large cohort outcome studies and meaningful comparative analyses to fully establish the clinical advantages of the React 71 Catheter over other devices. Further research is needed to confirm its efficacy and safety profile.
Frequently Asked Questions
What are the clinical indications for React 71 Catheter?
The React 71 Catheter 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 improved recanalization rates when the React 71 Catheter is used with stent retrievers in mechanical thrombectomy procedures.
What complications have been reported?
Reported complications include risks typical of thrombectomy procedures, such as vessel injury or hemorrhage, though specific data for the React 71 Catheter is limited.
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.