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
Stroke is a disease that affects the arteries within and leading to the brain. An ischemic stroke occurs when a blood vessel to the brain is blocked by an embolus or blood clot. Worldwide, stroke remains the second-leading cause of death and the third-leading cause of death and disability combined. It is estimated that the global cost of stroke is over $725 billion.

About Infinity Neuro
Infinity Neuro has a combined 50+ years of experience in the medical device industry. All our team members have built outstanding careers in every facet of the business including product development, engineering, research, marketing, and commercialization of groundbreaking, innovative, patented medical devices.

Decades of experience has afforded the Infinity Neuro team the ability to build longstanding relationships with the physician community and business professionals worldwide.  These relationships are an integral part of the success of Infinity Neuro.

The Infinity Neuro team has an established history with proven success at developing lifesaving neurovascular devices, gaining regulatory approvals, and accomplishing successful commercial product launches worldwide.

Contact Information:
James D. Nonato
Infinity Neuro
Lake Forest, CA USA
Phone: +1 845-480-2739

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


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