Rapid Medical’s Tigertriever Approved in Japan

December 13, 2023—Rapid Medical, a developer of neurovascular devices, announced that Japan’s Pharmaceuticals and Medical Devices Agency has approved the company’s Tigertriever revascularization device for mechanical thrombectomy. Kaneka Corporation has exclusive distribution rights with Rapid Medical in Japan.

According to the company, Tigertriever’s user-control capability is particularly 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.

The company noted that the multicenter TIGER trial demonstrated superiority of the Tigertriever to conventional stent retrievers. The trial showed 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. Additionally, the TIGER trial showed fast procedure times, on par with aspiration alone, driven by a very high first-pass success rate.

In March 2021, the TIGER trial findings were presented at the American Stroke Association’s annual International Stroke Conference. The study was also published by Rishi Gupta, MD, et al in Stroke (2021;52:1534–1544). Dr. Gupta and Jeffery L. Saver, MD, served as Principal Investigators of TIGER.

Additionally, a subgroup analysis of the TIGER trial showed that the device maintained these results in complex ischemic stroke patients with underlying ICAD. These findings were reported at the 2023 Society of Vascular and Interventional Neurology annual meeting held November 16-18 in Miami Beach, Florida, and published by Diego J. Ojeda, MD, et al online in Journal of NeuroInterventional Surgery.