FDA Grants First Approval for Venous Stent to Treat Severe IIH

The US Food and Drug Administration has granted a humanitarian device exemption to Serenity Medical for its River stent, marking the first approved cerebral venous stent for treating severe idiopathic intracranial hypertension.

IIH, a condition caused by increased pressure in the skull, often leads to headaches, vision problems, and cognitive issues. It primarily affects women aged 20–50 with obesity. Treatment options for severe cases have been limited.

The River stent is designed to keep narrowed brain veins open, improving blood flow and reducing pressure. It is intended for adults with significant vein narrowing who do not respond to medical therapies.

Approval was based on a 39-patient study showing positive safety and efficacy outcomes, including improvements in symptoms and quality of life. The device offers a much-needed option for patients with few alternatives.

05-04-2026