Rapid Medical Wins Japanese Approval for TIGERTRIEVER Device

Rapid Medical has received Japanese approval for its TIGERTRIEVER revascularization device. With the blessing of Japan’s Pharmaceuticals and Medical Devices Agency (PMDA, TIGERTRIEVER serves as the first device to offer individualized solutions for mechanical thrombectomy, according to the company.
 
TIGERTRIEVER technology is inspired by advancements in aerospace engineering and transforms thrombectomy procedures from a passive to an active approach. Compared to traditional stent retrievers, TIGERTRIEVER offers user control, which is important in Japan and other Asian countries with a high prevalence of underlying intracranial atherosclerotic disease (ICAD). The device can be expanded and reduced on demand, activating clot integration and potentially reducing the risk of vessel perforation or damage during device retrieval.
 
“Japan now has access to a single tool that adjusts specifically to the patient’s anatomy for high first pass success,” Rapid Medical’s International President Eitan Havis stated. “It has been a much-needed endeavor to introduce patient-specific stroke procedures to Japan and other Asian countries like China since there is no room for compromise with the brain.”
 
A published clinical study demonstrated superiority to conventional stent retrievers. Results of a TIGER multicenter trial presented three statistically significant improvements—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 first-pass success rate. A subgroup analysis maintained these results even in challenging stenotic ICAD patients.³
 
Kaneka Corporation, headquartered in Tokyo, Japan, has exclusive distribution rights with Rapid Medical in the country. 

Rapid Medical is pioneering advanced interventional devices that treat ischemic and hemorrhagic stroke. Using proprietary manufacturing techniques, Rapid Medical’s products are remotely adjustable and fully visible, enabling 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
³ Ojeda DJ, Ghannam M, Sanchez S, et al. Tigertriever in the treatment of acute ischemic stroke with underlying intracranial atherosclerotic disease [published online ahead of print, 2023 Sep 30]. J Neurointerv Surg. 2023;jnis-2023-020796. doi:10.1136/jnis-2023-020796