Israel-based medical device company Rapid Medical has announced that its revascularization device, Tigertriever, has received approval in China. The device is hailed as the world’s only adjustable thrombectomy device, used for the removal of blood clots from the brain to treat ischemic stroke.
Approval Based on COMPASS Trial Results
The approval of Tigertriever as a first-line therapy for large vessel occlusion was based on the results of the COMPASS multicenter, randomized, open label, blinded outcome, non-inferiority trial. This trial compared aspiration thrombectomy with stent retriever thrombectomy, providing a robust basis for the device’s efficacy and safety.
Superior Performance in Clinical Trials
Additional trials have demonstrated that the Tigertriever device outperforms competitors in statistically significant ways, including restoring blood flow to the brain, achieving good clinical outcomes, and reducing emboli to new territory. These results were compared to an average from six pivotal stent retriever trials, highlighting Tigertriever’s superior performance.
Fast Procedure Times and High Success Rates
The TIGER trial further showcased the device’s capabilities, with fast procedure times that are on par with aspiration alone. This is driven by a very high rate of first-pass success, indicating the device’s efficiency and potential to improve patient outcomes in the treatment of ischemic stroke.-Fineline Info & Tech
