Serenity Medical Gains FDA Humanitarian Device Exemption for River Cerebral Venous Stent

April 1, 2026—Serenity Medical announced that the United States FDA has granted Humanitarian Device Exemption (HDE) approval for the River stent for the treatment of severe idiopathic intracranial hypertension (IIH) in adult patients who have failed medical therapy. Serenity described River as a cerebral venous stent designed specifically for venous sinus stenosis in this population.

The approval gives neurointerventionalists a labeled device option for a condition that has had limited appropriate procedural therapies. In the press release, the company said IIH is associated with elevated intracranial pressure and can present with chronic headache, papilledema, visual symptoms, pulsatile tinnitus, cognitive impairment, and risk of vision loss. Serenity said the intended population is adults with severe, refractory disease or intolerance to medical treatment.

“Delivering the first venous stent approved for severe, refractory IIH is incredibly meaningful to our dedicated team and to people living with IIH who have had limited options for relief until now,” commented Y. Pierre Gobin, MD, Founder of Serenity Medical and a neurointerventional specialist with Weill-Cornell Medicine, in the company’s press release. “Our company was founded with the goal of addressing a problem that has long perplexed the medical community and caused debilitating symptoms in the women suffering with it. Reaching this moment reflects years of persistence, partnership with investigators, and a shared commitment to bring new possibilities to this underserved patient community.”

Serenity said the FDA decision was based on findings from the River study, a prospective, open-label, multicenter, single-arm study involving 39 patients at five United States centers who received the River stent for treatment of IIH refractory to or intolerant of medical therapy. The company reported that the study met its primary safety endpoint at 1 year, with a major adverse event rate of 5.4%. Serenity also reported improvements in opening cerebrospinal fluid pressure, headache, papilledema, pulsatile tinnitus, visual symptoms, and quality-of-life scores.

Adnan Siddiqui, MD, PhD, of the Jacobs School of Medicine & Biomedical Sciences and senior author of the River Study publication, added in the press release, “The River study was groundbreaking as the first-of-its-kind study to evaluate a stent specifically designed for intracranial venous sinuses. There is no other stent that is optimized or approved for this indication. The FDA’s review and acceptance of these data will now enable access to this important tool to the broader medical community to treat these patients.”

Serenity also announced a strategic commercialization partnership with Radical Catheter Technologies. The company said the collaboration will focus on launch support, physician education, and procedural adoption at leading neurovascular centers nationwide.