Rapid Medical announced at the ongoing Society of NeuroInterventional Surgery’s (SNIS) 19th annual meeting (25–29 July, Toronto, Canada) that it has recently received US Food and Drug Administration (FDA) 510(k) clearance for its TIGERTRIEVER 13 device to treat large vessel occlusions (LVOs).
TIGERTRIEVER 13 is the smallest revascularisation device in the world to date, according to the company, and is designed to remove thrombus from delicate brain blood vessels during an ischaemic stroke. It is the only device that adjusts to the vasculature and clot—a more atraumatic approach than existing devices—a Rapid press release adds.
“The neurovascular field has been waiting for a thrombectomy device dedicated to small vessels,” said David Fiorella (Stony Brook University Medical Center, New York, USA). “Medical therapy is currently suboptimal for these patients, so there can be a huge benefit for devices that emergently restore blood flow while minimising the potential for harm.”
“Existing stent retrievers lack any adjustability—they open passively and are pulled from the brain fully expanded,” the release details. The unique adjustability of the TIGERTRIEVER portfolio comes from complex three-dimensional braiding borrowed from recent advances in aerospace engineering, it continues.
TIGERTRIEVER is precisely controlled to capture the thrombus and remove the tension from the vasculature before removal. Adjustability also gives TIGERTRIEVER 13 the lowest profile of any stent retriever—24% smaller than 3mm devices, providing easier navigation in challenging anatomies, the company claims. It also states that the ability to tailor each procedure can provide new safety levels for higher-risk thrombectomies.
“Thousands of procedures have already been performed with TIGERTRIEVER 13 worldwide,” added James Romero, president, Americas, Rapid Medical. “Now, US physicians finally have access to TIGERTRIEVER 13’s unique capabilities to further benefit patients suffering from ischaemic stroke.”