Rapid Medical Gets FDA OK for Ultra-Small Clot Retriever

The device adjusts to the vasculature and clot.

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Rapid Medical, a developer of advanced neurovascular devices, announces FDA 510(k) clearance for TIGERTRIEVER 13 for large vessel occlusions.

The company said TIGERTRIEVER 13 is the smallest revascularization device in the world to date and is designed to remove thrombus from delicate brain blood vessels during an ischemic stroke. It is the only device that adjusts to the vasculature and clot, a more atraumatic approach than existing devices.

“The neurovascular field has been waiting for a thrombectomy device dedicated to small vessels,” said Dr. David Fiorella of Stony Brook University Medical Center in Stony Brook, NY. “Medical therapy is currently suboptimal for these patients, so there can be a huge benefit for devices that emergently restore blood flow while minimizing the potential for harm.”

Existing stent retrievers open passively and are pulled from the brain fully expanded. The unique adjustability of the TIGERTRIEVER portfolio comes from three-dimensional braiding borrowed from recent advances in aerospace engineering. 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 3 mm devices, providing easier navigation in challenging anatomies. The ability to tailor each procedure can provide new safety levels for higher-risk thrombectomies.

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