Infinity Neuro’s Inspira Aspiration Catheter Receives CE Mark Approval to Treat Stroke

January 27, 2023—Infinity Neuro announced that its Inspira aspiration catheter has received CE Mark approval. The European commercial launch of the devices is underway through a network of European Union distributors.

Infinity Neuro stated that the Inspira aspiration catheter is designed for navigation and aspiration performance that allow access of targeted vessels easily, restoration of cerebral blood flow quickly, and retrieval of clots in patients experiencing acute ischemic stroke caused by large vessel occlusions.

Specifically, Inspira is indicated for the injection of intravascular fluids, the introduction of interventional devices into the peripheral and neurovasculature, and removal/aspiration of soft emboli and thrombi from the arterial system, including the peripheral and neuro vasculature.

According to Infinity Neuro, the launch of Inspira, which represents the company's first product, is the first phase of a complementary integrated system that will offer greater ease-of-use and performance. The company plans to launch a full range of products for the treatment of ischemic and hemorrhagic stroke throughout 2023 and beyond.

Additionally, this approval milestone represents the company’s commitment and ability to attain class III medical device approvals through the new, rigorous European MDR CE certification process, stated Infinity Neuro.