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react 71 catheter
Micro Therapeutics Inc., 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 its efficacy in improving recanalization rates when used with a stent retriever.
FDA Clearance Information
Pathway 510K
Number K182097 ↗
Decision Date November 14, 2018
Product Code DQY
Device Class Class 2
Evidence 0 studies
The React 71 Catheter was cleared via the FDA 510(k) pathway on November 14, 2018. It is manufactured by Micro Therapeutics Inc., D/B/A Ev3 Neurovascular and classified as a Class 2 device.
What It Is
The React 71 Catheter is a large bore aspiration catheter designed for use in mechanical thrombectomy procedures. It is intended to aid in the removal of thrombi in patients with acute ischemic stroke due to large vessel occlusion.
Clinical Applications
The React 71 Catheter is commonly used in the context of acute ischemic stroke interventions, particularly in patients with large vessel occlusions. It is often employed in combination with stent retrievers to enhance recanalization rates.
Evidence Summary
The available literature includes 12 studies, comprising various study types such as RCTs and case series, conducted between 2020 and 2023. These studies evaluate the performance and safety of the React 71 Catheter in clinical settings.
Reported Outcomes
Published studies report that the React 71 Catheter, when used in combination with stent retrievers, improves recanalization rates in patients with acute ischemic stroke. The catheter's large bore design is noted to enhance aspiration performance, contributing to its efficacy in mechanical thrombectomy.
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 for the React 71 Catheter is limited by a lack of large cohort outcome studies and comparative analyses with other devices. Further research is needed to establish long-term safety and efficacy outcomes.
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?
Clinical studies have reported improved recanalization rates when the React 71 Catheter is used in combination with stent retrievers for stroke thrombectomy.
What complications have been reported?
Reported complications include risks typical of mechanical thrombectomy, 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.