Germany-based neurovascular devices maker Rapid Medical has received China’s National Medical Product Administration (NMPA) approval for its TIGERTRIEVER revascularisation device.
The TIGERTRIEVER technology builds on advancements in aerospace engineering and enables precise control during mechanical thrombectomy.
Its unique operation changes the procedures from a passive to an active approach that advances clot capture and potentially reduces the risk of vascular injury during removal.
The comparable, leading stent retrievers are self-expanding and static, which can lead to suboptimal clot removal and minimal vessel protection.
According to Rapid Medical, TIGERTRIEVER is the first device to provide patient-specific solutions for removing blood clots from the brain to advance the treatment of ischemic stroke.
Rapid Medical co-founder and CEO Ronen Eckhouse said: “This new approval for TIGERTRIEVER propels treatment for ischemic stroke patients in China.
“We are fortunate to have an excellent partner with MicroPort Scientific Corporation, who understand the need to expand neuro-interventional capabilities and individualised stroke care for these patients.”
According to the previously published clinical studies, TIGERTRIEVER showed superiority to conventional stent retrievers.
In the TIGER multicentre trial, the device showed statistically significant improvements in restoring blood flow to the brain, good clinical outcomes, and reducing emboli to new territory.
Also, the TIGER trial showed improvement in procedure times compared to aspiration alone, driven by a very high rate of first-pass success.
Furthermore, Rapid Medical has signed an exclusive distribution agreement with MicroPort NeuroTech, a subsidiary of China-based MicroPort Scientific Corp.
MicroPort NeuroTech president Zhiyong Xie said: “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.
“TIGERTRIEVER provides Chinese physicians with a new choice of neurological intervention medical devices that will benefit more patients.”