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 todeliver next-level navigation and aspiration performance; designed to access targeted vessels easily, quicklyrestore cerebral blood flow, and retrieve clots in patients experiencing acute ischemic stroke (AIS) due to alarge vessel occlusion (LVO). According to the company, Inspira™ is the first phase of a complementaryintegrated system which will offer greater ease-of-use and performance with first-to-market productinnovations. Additionally, this milestone represents the company’s commitment and ability to attain class IIImedical device approvals through the new, rigorous European MDR CE certification process which in today’smarket, medical device companies find challenging. This marks the first neurovascular device approved underthe 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 secondleading 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.
James D. Nonato
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.