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React 68 Catheter
Micro Therapeutics Inc., D/B/A Ev3 Neurovascular
Product: Solitaire X-PACK — all models and sizes
Summary: The React 68 catheter is a device used for aspiration in mechanical thrombectomy procedures, primarily for acute ischemic stroke. Key evidence suggests its effectiveness when combined with stent retrievers.
FDA Clearance Information
Pathway ?
510(k)
Number ?
K180715 ↗
Decision Date ?
July 4, 2018
Product Code ?
DQY Catheter, Percutaneous
Device Class ?
Class 2
Evidence ?
0 studies
The React 68 catheter was cleared by the FDA through the 510(k) pathway on July 4, 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 68 catheter is designed for aspiration during mechanical thrombectomy procedures. It is used to remove thrombi in patients with acute ischemic stroke due to large vessel occlusion, enhancing recanalization rates.
FDA-Cleared Indications
- Used to introduce interventional devices and/or infuse diagnostic, therapeutic, or other materials into the peripheral and neurovascular systems.
- Intended for use in vessels of the peripheral and neurovascular systems that are appropriate for catheter-based intervention.
- Cleared as a Class II percutaneous catheter under FDA product code DQY.
Clinical Applications
- Aspiration thrombectomy in the neurovasculature during treatment of acute ischemic stroke.
- Use as an aspiration or delivery catheter during endovascular clot-retrieval procedures.
- Catheter access for selected diagnostic or therapeutic interventions in appropriately sized peripheral or neurovascular vessels.
Reported off-label uses
- Aspiration thrombectomy for selected venous thromboembolism, including deep-vein thrombosis, when used according to institutional practice and clinician judgment.
- Aspiration of thrombus in other peripheral vascular beds outside the device's specific neurovascular labeling.
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 11 studies, with a mix of randomized controlled trials and observational studies, published between 2006 and 2023. These studies evaluate the efficacy and safety of the React 68 catheter in clinical settings.
Reported Outcomes
Published studies report that the React 68 catheter, when used in combination with stent retrievers, improves recanalization rates in patients with acute ischemic stroke. Initial experiences suggest it is comparable to other aspiration catheters like the ACE 68.
Safety Profile
Reported complications include those typical of mechanical thrombectomy procedures, such as vessel perforation and distal embolization. However, specific safety data for the React 68 catheter is limited in the provided studies.
Evidence Limitations
The evidence is limited by the small number of studies directly evaluating the React 68 catheter. Further research is needed to establish long-term safety and efficacy, as well as comparisons with other devices.
Practical Considerations
- The catheter is a large-bore aspiration catheter; the exact inner and outer dimensions, usable length, and compatibility should be confirmed in the current manufacturer instructions for use.
- It is generally advanced over a guidewire or through a compatible access and delivery system under fluoroscopic or other appropriate imaging guidance.
- Compatibility with guidewires, guide catheters, aspiration pumps, stent retrievers, and vascular anatomy must be confirmed before use.
- MRI safety and conditional-use details depend on the specific device configuration and labeling; verify the current MRI safety information before scanning a patient with any component in place.
- Potential complications include vascular injury, perforation, dissection, hemorrhage, distal embolization, thrombus, infection, vasospasm, and complications related to contrast, anesthesia, or vascular access.
Procedures that use this device
Frequently Asked Questions
What are the clinical indications for React 68 catheter?
The React 68 catheter is indicated for use in mechanical thrombectomy procedures to treat acute ischemic stroke due to large vessel occlusion.
What outcomes have been reported in clinical studies?
Studies report improved recanalization rates when the React 68 catheter is used with stent retrievers in mechanical thrombectomy procedures.
What complications have been reported?
Reported complications include vessel perforation and distal embolization, common to mechanical thrombectomy procedures.
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.