📊 Evidence-Based Reference
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 ?
510(k)
Number ?
K241177 ↗
Decision Date ?
May 28, 2024
Product Code ?
DQY Catheter, Percutaneous
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.
FDA-Cleared Indications
- Removal of thrombus from the neurovasculature in patients experiencing acute ischemic stroke.
- Use in conjunction with compatible guide catheters, microcatheters, guidewires, and other endovascular devices during thrombectomy procedures.
- Use in patients who are eligible for endovascular treatment according to the applicable device labeling and clinical guidelines.
Clinical Applications
- Aspiration thrombectomy for acute ischemic stroke caused by large-vessel occlusion.
- Distal access and clot aspiration during neurointerventional thrombectomy.
- Combined treatment with a stent retriever, when clinically appropriate, to assist clot removal and vessel reperfusion.
Reported off-label uses
- Aspiration thrombectomy for selected extracranial carotid artery or vertebral artery thrombi.
- Clot aspiration in selected venous thrombectomy procedures, depending on anatomy, access requirements, and operator judgment.
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 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.
Practical Considerations
- The catheter is a large-bore aspiration device and must be used with compatible guide catheters, aspiration tubing, hemostatic valves, wires, and other accessories specified in the instructions for use.
- It is intended for use by clinicians trained in neurovascular or endovascular procedures, with fluoroscopic or other appropriate imaging guidance.
- The catheter may be used with a stent retriever, but combined therapy is not required in every case and should be selected according to the patient's anatomy and clot characteristics.
- MRI safety depends on the catheter's labeling and whether it remains in the patient; users should consult the current instructions for use before MRI. A catheter left in place may present risks related to heating, movement, or image artifact.
- Potential complications include vessel injury, perforation, dissection, bleeding, embolization, vasospasm, infection, and complications related to vascular access or contrast.
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.