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Rapid Medical's Ultra-Small and Only Adjustable Thromb Retriever Receives FDA Clearance
2022-08-05 06:57:00 【sinat_41698914】
Rapid Medical's Ultra-Small and Only Adjustable Thromb Retriever Receives FDA Approval
Leading Developer of Advanced Neurovascular DevicesRapid Medical announced at the Society for Neurointerventional Surgery (SNIS) 19th Annual Meeting in Toronto in 2022,TIGERTRIEVER?13 has received FDA 510(k) clearance for large vessel occlusion.The TIGERTRIEVER 13 is the world's smallest volume revascularization device to date, designed to remove thrombus in delicate cerebral vessels during ischemic stroke.It is the only device that can accommodate vascular structures and blood clots and is less invasive than existing devices.
NYU Stony Brook Medical CenterDr. David FiorellaA thrombectomy device for small vessels. Existing drug therapy is not ideal for these patients. A device that can urgently restore blood flow while minimizing potential harm could be of great benefit.”
Existing stent retrievers lack any adjustability - they are passively deployed when in use and fully deployed when withdrawn from the brain.The unique adjustability of the TIGERTRIEVER series comes from a complex three-dimensional braided structure, borrowed from recent advances in aerospace engineering.TIGERTRIEVER can be precisely manipulated to capture the thrombus and is able to relieve tension in the vascular structure prior to enucleation.Adjustability also allows the TIGERTRIEVER 13 to have the slimmest profile of any stent retriever—24% smaller than a 3mm instrument, enabling easier movement in challenging anatomy.The device can also be tailored for each procedure, enabling new levels of safety in high-risk thrombectomy procedures.
James Romero, President of Rapid Medical Americas, said: "Thousands of TIGERTRIEVER 13 procedures have been performed worldwide. Now physicians in the United States can finally take advantage of the unique capabilities of the TIGERTRIEVER 13 to further benefit ischemic stroke patients."
About Rapid Medical
Rapid Medical develops advanced responsive interventional devices for the treatment of neurovascular diseases such as ischemic and hemorrhagic stroke.Rapid Medical's products utilize novel manufacturing techniques that are remotely adjustable and fully visible.This enables physicians to respond to the intravascular environment in real time and better control surgical outcomes.TIGERTRIEVER? 17 & 21, COMANECI? and COLUMBUS?/DRIVEWIRE are CE marked and FDA certified.TIGERTRIEVER?13 and XL is also CE marked.
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