Rapid Medical announced that it received FDA 510(k) clearance for its Tigertriever 13 device for treating large vessel occlusions.
Yokneam, Israel-based Rapid Medical designed Tigertriever 13 to remove thrombus from delicate brain blood vessels during an ischemic stroke.
Rapid Medical said in a news release that Tigertriever 13 is the smallest revascularization device in the world to date, adjusting to the vasculature and clot through a more atraumatic approach than existing devices.
“Thousands of procedures have already been performed with Tigertriever 13 worldwide,” Rapid Medical President, Americas James Romero said in the release. “Now U.S. physicians finally have access to Tigertriever 13’s unique capabilities to further benefit patients suffering from ischemic stroke.”
The company said Tigertriever has adjustability capabilities that existing stent retrievers lack, with three-dimensional braiding borrowed from recent advances in aerospace engineering.
Rapid Medical’s device is precisely controlled to capture the thrombus and remove the tension from the vasculature before removal. Its adjustability gives it what the company describes as 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.
“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, New York. “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.”