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Vesalio Attains Key FDA Clinical Study Milestone

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Nashville, TN, April 28, 2021 –(PR.com)– Vesalio announces it has accomplished a key FDA IDE study milestone to support entry into the US neurovascular market. Enrollment in the VITAL(1) clinical trial, assessing the company’s NeVa VS™ technology in the treatment of symptomatic cerebral vasospasm following aneurysmal subarachnoid hemorrhage (aSAH), has been completed.

Cerebral vasospasm is an intense and prolonged narrowing of the arteries that develops gradually over the first few days following aneurysm rupture. This narrowing can reduce blood flow and is considered to be one of the leading causes of death after such ruptures. Current treatment for vasospasm includes endovascular administration of intra-arterial vasodilators and balloon angioplasty, utilized off-label for this indication. Currently, there is no medical technology cleared for the treatment of vasospasm in the United States.

“Completion of this IDE study is a…

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