Rapid Medical krijgt FDA-goedkeuring voor het kleinste en enige verstelbare trombectomie apparaat
TIGERTRIEVER™13 is ontworpen om de vaatspanning te verminderen tijdens de behandeling van een ischemische beroerte
YOKNEAM, Israël & TORONTO–(BUSINESS WIRE)– Rapid Medical, een toonaangevende ontwikkelaar van geavanceerde neurovasculaire apparaten, kondigt FDA 510(k) goedkeuring aan voor TIGERTRIEVER™13 voor occlusies van grote bloedvaten op de 19e jaarlijkse bijeenkomst van de Society of NeuroInterventional Surgery’s (SNIS) in 2022 in Toronto. TIGERTRIEVER 13 is tot nu toe het kleinste revascularisatie apparaat ter wereld en is ontworpen om trombus uit gevoelige hersenbloedvaten te verwijderen tijdens een ischemische beroerte. Het is het enige apparaat dat zich aanpast aan het vaatstelsel en stolsel, een meer atraumatische benadering dan bestaande apparaten.
Rapid Medical Gains FDA Clearance for the Smallest & Only Adjustable Thrombectomy Device
TIGERTRIEVER™13 is designed to reduce vessel tension during ischemic stroke treatment
YOKNEAM, Israel & TORONTO–(BUSINESS WIRE)– Rapid Medical, a leading developer of advanced neurovascular devices, announces FDA 510(k) clearance for TIGERTRIEVER™13 for large vessel occlusions at the 2022 Society of NeuroInterventional Surgery’s (SNIS) 19th Annual Meeting in Toronto. 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,” states 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 lack any adjustability– they open passively and are pulled from the brain fully expanded. The unique adjustability of the TIGERTRIEVER portfolio comes from complex 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.
“Thousands of procedures have already been performed with TIGERTRIEVER 13 worldwide,” describes James Romero, President, Americas, of Rapid Medical. “Now U.S. physicians finally have access to TIGERTRIEVER 13’s unique capabilities to further benefit patients suffering from ischemic stroke.”
About Rapid Medical
Rapid Medical develops the premier, responsive interventional devices for neurovascular diseases such as ischemic and hemorrhagic stroke. Utilizing novel manufacturing techniques, Rapid Medical’s products are remotely adjustable and fully visible. This enables physicians to respond in real-time to the intravascular environment and have greater control over procedural outcomes. TIGERTRIEVER™17 and 21, COMANECI™, and COLUMBUS™/DRIVEWIRE are CE marked and FDA cleared. TIGERTRIEVER™13 and XL are also CE marked. More information is available at www.rapid-medical.com.
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