Rapid Medical has received approval from Japan’s Pharmaceuticals and Medical Devices Agency (PMDA) for its TIGERTRIEVER revascularisation device.
This device is intended to deliver individualised solutions for mechanical thrombectomy.
The TIGERTRIEVER technology is designed to revolutionise thrombectomy procedures from a passive to an active approach.
The device provides users with better control, which is important in Japan and other countries in Asia where there is a high incidence of underlying intracranial atherosclerotic disease (ICAD), compared to traditional stent retrievers.
It can be expanded and reduced as needed, facilitating clot integration, and potentially reducing vessel perforation or damage risk when retrieving the device.
The TIGER multicentre trial revealed three significant improvements compared to an average from six pivotal stent retriever studies.
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The improvements include good clinical outcomes, restoring blood flow to the brain and reducing emboli to new territory.
In addition, the trial demonstrated quick procedure times comparable to aspiration alone, supported by a high first-pass success rate.
An analysis focused on a subgroup showed that these positive outcomes were sustained, even in patients with challenging stenotic ICAD.
Rapid Medical International president Eitan Havis said: “Japan now has access to a single tool that adjusts specifically to the patient’s anatomy for high first pass success.
“It has been a much-needed endeavour to introduce patient-specific stroke procedures to Japan and other Asian countries like China since there is no room for compromise with the brain.”
Rapid Medical has announced an exclusive partnership with Kaneka for the distribution of the TIGERTRIEVER device in Japan.
In September 2023, the company obtained approval from China’s National Medical Product Administration (NMPA) for the revascularisation device.
The company also received approval from the US Food and Drug Administration (FDA) and CE mark for TIGERTRIEVER 13, 17 and 21, COMANECI and COLUMBUS/DRIVEWIRE devices.
The company also received approval from the US Food and Drug Administration (FDA) and CE mark for TIGERTRIEVER 13, 17 and 21, COMANECI and COLUMBUS/DRIVEWIRE devices.
