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react 68 catheter
Micro Therapeutics Inc., D/B/A Ev3 Neurovascular
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
510K
Number
K180715 ↗
Decision Date
July 4, 2018
Product Code
DQY
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.
Clinical Applications
Commonly used in the treatment of acute ischemic stroke, the React 68 catheter is employed in mechanical thrombectomy procedures, often in combination with stent retrievers, to improve patient outcomes by restoring blood flow.
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.
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.