Harrison, New York-based Serenity said approval makes River the first FDA-approved cerebral venous stent. The company specifically developed its technology for the treatment of severe idiopathic intracranial hypertension (IIH) in adult patients who have failed medical therapy.

IIH, caused by elevated intracranial pressure, leads to debilitating chronic headaches, vision loss and cognitive impairments. The company says it remains difficult to find appropriate, FDA-approved surgical therapies to safely relieve its symptoms.