FDA clears first adjustable stent retriever

Rapid Medical, developer of responsive, adjustable neurovascular devices, has announced the FDA clearance of its Tigertriever revascularization device for use in the treatment of ischemic stroke. 

Tigertriever is the first stent retriever to offer intelligent control, enabling neuro interventionalists to better remove blood clots and restore blood flow the brain following an ischemic event. Already approved in Europe, more than 5,000 patients have been treated with the device.

Ronen Eckhouse, Rapid Medical Co-founder and CEO states: “The FDA clearance of Tigertriever is a significant milestone in the development and growth of Rapid’s global business. It is a great testament to the advantages of our proprietary 3D braiding technology — the platform for our portfolio of remotely adjustable neurovascular devices, including the Comaneci and Columbus products.”

Existing stent retrievers are non-adjustable, passive devices, delivered to the occlusion minimally invasively through the vasculature. When unconfined, they slowly expand into the blood clot. The blockage is hopefully captured and removed as the device is retrieved. Though currently recognized as the gold standard in treating large vessel ischemic stroke, traditional stent retrievers have significant limitations. They cannot be adjusted for patient variability and fail in about 30% of revascularization procedures.

Tigertriever provides physicians with intelligent control during thrombectomy procedures. With full device visibility and adjustability, physicians adapt their approach to visual and tactile feedback as needed. The benefit of this tailored approach to ischemic stroke patients was proven in the recently published TIGER Trial.