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NEWS

PRESS RELEASE

Vesalio announces EU MDR Certification

Nashville, Tennessee - (OCT 13, 2022) – VESALIO announces the EU MDR certification of its product lines significantly ahead of the May 2023 deadline. This important milestone marks the third in a series of recent regulatory achievements along with the CE marking of NeVa NET™, VESALIO’s new, flagship neuro-thrombectomy device containing a unique integrated distal filter technology and the FDA HDE approval of NeVa VS™, indicated for the adjunctive treatment of aSAH-induced cerebral vasospasm. NeVa VS is the first medical device approved in the U.S. for this indication.

PRESS RELEASE

Vesalio announces FDA Approval of the NeVa VS™ to treat cerebral vasospa...

Nashville, Tennessee - (Sept 15, 2022) – Vesalio announces FDA HDE approval for commercialization of NeVa VS, indicated for the adjunct treatment of symptomatic cerebral vasospasm (CV) following aneurysmal subarachnoid hemorrhage (aSAH), the major cause of death and disability in this patient population.  This is the first intracranial technology approved for this indication in the U.S.

PRESS RELEASE

Wallaby / phenox announces global launch of the pEGASUS HPC Stent System...

Nice, France (September 7, 2022). Wallaby / phenox has announced the successful global launch of their novel pEGASUS HPC stent at the ESMINT 2022 congress in Nice, France. The introduction of the pEGASUS stent enables more patients to benefit from the HPC surface modification in stent-assisted coiling treatments as well as intracranial atherosclerotic diseases (ICAD) and dissections. The application of the surface modification to the stent results in enhanced safety by significantly reducing thrombogenic complications. 

BREAKING NEWS

PRESS RELEASE

Vesalio announces CE Approval for new NeVa NET™, the first integrated cl...

Nashville, Tennessee - (September 1, 2022) – In further expansion of their high-performance thrombectomy portfolio, Vesalio announced CE approval for commercialization of the new NeVa NET, the first and only thrombectomy device with an integrated clot micro-filtration technology. This one-of-a-kind stent retriever combines the company’s proprietary Drop Zone technology, proven to work on all clot types, with a finely braided micro-filter net element integrated into the closed distal tip of the device.

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