Infinity Neuro Receives CE Mark Approval for Their First Device to Treat Stroke
LAKE FOREST, Calif., Jan. 27, 2023 Infinity Neuro announced today that its Inspira™ aspiration catheters received CE Mark approval and are now commercially available in Europe. This is the first offering from Infinity Neuro which plans to launch a full range of products for the treatment of ischemic and hemorrhagic stroke throughout 2023 and beyond. The Inspira™ aspiration catheters are physician inspired to deliver next-level navigation and aspiration performance; designed to access targeted vessels easily, quickly restore cerebral blood flow, and retrieve clots in patients experiencing acute ischemic stroke (AIS) due to a large vessel occlusion (LVO). According to the company, Inspira™ is the first phase of a complementary integrated system which will offer greater ease-of-use and performance with first-to-market product innovations. Additionally, this milestone represents the company's commitment and ability to attain class III medical device approvals through the new, rigorous European MDR CE certification process which in today's market, medical device companies find challenging. This marks the first neurovascular device approved under the new European MDR CE certification process as an original submission. The European commercial launch of Inspira™ aspiration catheters are underway through a network of EU distributors.
About Ischemic Stroke
About Infinity Neuro
The Inspira™ Aspiration Catheter is indicated for injection of intravascular fluids, the introduction of interventional devices into the peripheral and neuro vasculature, and removal/aspiration of soft emboli and thrombi from the arterial system, including the peripheral and neuro vasculature.
Indications, contraindications, warnings, and instructions for use can be found on the product labeling supplied with each device.
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SOURCE Infinity Neuro