Chinese Regulators Approve World’s Only Adjustable Thrombectomy Device

Rapid Medical has received National Medical Product Administration (NMPA) approval in China for its TIGERTRIEVER revascularization device. With this milestone, TIGERTRIEVER becomes the first device to offer patient-specific solutions for removing blood clots from the brain to advance the treatment of ischemic stroke.
 
“This new approval for TIGERTRIEVER propels treatment for ischemic stroke patients in China,” Rapid Medical Co-Founder/CEO Ronen Eckhouse said. “We are fortunate to have an excellent partner with MicroPort Scientific Corporation, who understands the need to expand neurointerventional capabilities and individualized stroke care for these patients.”
 
TIGERTRIEVER technology, fueled by advancements in aerospace engineering, enables precise control during mechanical thrombectomy. Its unique operation changes these procedures from a passive to an active approach that accelerates clot capture and potentially reduces the risk of vascular injury during removal. Comparable, leading stent retrievers are self-expanding and static, which can lead to suboptimal clot removal and minimal vessel protection.
 
Published clinical studies demonstrate superiority to conventional stent retrievers. The results of the TIGER multicenter trial presented three statistically significant improvements—in restoring blood flow to the brain, good clinical outcomes, and reducing emboli to new territory—compared to an average from six pivotal stent retriever trials.¹ Additionally, the TIGER trial showed fast procedure times, on par with aspiration alone,² driven by a very high rate of first-pass success.
 
“The successful launch of TIGERTRIEVER in China represents another stroke intervention innovation that can be applied in the real world, introducing the concept of tailored thrombectomy using an adjustable stent retriever that allows physicians to navigate procedures and unexpected circumstances with added control,” MicroPort NeuroTech President Zhiyong Xie stated. “TIGERTRIEVER provides Chinese physicians with a new choice of neurological intervention medical devices that will benefit more patients.”
 
Rapid Medical has an exclusive distribution agreement with MicroPort NeuroTech, a subsidiary of MicroPort Scientific Corporation (headquartered in China). Rapid Medical pioneers advanced interventional devices to treat neurovascular diseases such as ischemic and hemorrhagic stroke. Using proprietary manufacturing techniques, Rapid Medical’s products are remotely adjustable and fully visible. This enables physicians to respond in real-time to the anatomy and tailor the approach to every patient for better procedural outcomes. TIGERTRIEVER 13, 17 and 21, COMANECI, and COLUMBUS/DRIVEWIRE are CE marked and cleared by the U.S. Food and Drug Administration. TIGERTRIEVER XL is also CE marked. 

References
¹ Gupta, Rishi et al. “New Class of Radially Adjustable Stentrievers for Acute Ischemic Stroke: Primary Results of the Multicenter TIGER Trial.” Stroke vol. 52,5 (2021): 1534-1544. doi:10.1161/STROKEAHA.121.034436
² Turk, Aquilla S 3rd et al. “Aspiration thrombectomy versus stent retriever thrombectomy as first-line approach for large vessel occlusion (COMPASS): a multicentre, randomised, open label, blinded outcome, non-inferiority trial.” Lancet (London, England)vol. 393,10175 (2019): 998-1008. doi:10.1016/S0140-6736(19)30297-1