US-based medical device company Infinity Neuro has received the CE mark for its Inspira aspiration catheters and is commercialising the catheters in Europe.
Inspira aspiration catheters, intended to deliver next-level navigation and aspiration performance, are the company’s first offering.
Infinity Neuro plans to launch a full range of products for the treatment of ischemic and haemorrhagic stroke throughout 2023 and beyond.
Stroke is a disease that affects the arteries within and leads to the brain, and an ischemic stroke occurs when a blood vessel to the brain is blocked by an embolus or blood clot.
The Inspira aspiration catheters are designed to access the targeted vessels to restore cerebral blood flow and retrieve clots in patients experiencing acute ischemic stroke (AIS) due to a large vessel occlusion (LVO).
The company said that Inspira is the first phase of a complementary integrated system to provide superior performance with first-to-market product innovations.
In addition, Inspira aspiration catheters are 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 is underway through a network of distributors in the EU, said the medical device company.
