React 71 Catheter
Micro Therapeutics Inc., D/B/A Ev3 Neurovascular
Product: Solitaire X-PACK — all models and sizes
FDA Clearance Information
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
FDA-Cleared Indications
- Removal of thrombus from the neurovascular system using aspiration.
- Use during endovascular treatment of acute ischemic stroke caused by large-vessel occlusion.
- Use with compatible devices and imaging guidance according to the cleared labeling and instructions for use.
Clinical Applications
- Aspiration thrombectomy for acute ischemic stroke involving a treatable intracranial large-vessel occlusion.
- Use as part of a direct aspiration thrombectomy technique.
- Use as an aspiration component during combined treatment with a compatible stent retriever.
- Endovascular neurointerventional procedures in which aspiration is used to remove clot from a cerebral artery.
Reported off-label uses
- Aspiration thrombectomy for selected extracranial carotid artery thrombus.
- Aspiration thrombectomy for selected thrombus in other peripheral or venous vessels.
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
Reported Outcomes
Safety Profile
Evidence Limitations
Practical Considerations
- The React 71 is a large-bore catheter and requires a compatible guide or access system, aspiration tubing, and appropriate intermediate or distal access support.
- The catheter is advanced over a guidewire under fluoroscopic imaging; anatomy, vessel size, tortuosity, and clot location affect deliverability and aspiration performance.
- Use requires a suitable access route, commonly femoral or radial arterial access for neurovascular procedures, selected according to the patient's anatomy and the operator's technique.
- MRI safety and conditional use should be confirmed from the current device labeling and institutional policy; do not assume that an implanted or retained catheter is safe for MRI.
- Potential complications include vessel injury, dissection, perforation, embolization, intracranial hemorrhage, vasospasm, infection, and access-site bleeding. Contraindications and warnings should be reviewed in the current instructions for use.
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.