Serenity Medical announced FDA Humanitarian Device Exemption (HDE) approval for its novel River stent. The River stent is for the treatment of severe idiopathic intracranial hypertension (IIH) in adult patients who have failed medical therapy, and according to the company press release is the first FDA-approved cerebral venous stent.

IIH is a serious neurological condition caused by elevated intracranial pressure, leading to debilitating chronic headaches, vision loss, and cognitive impairment. The condition disproportionately affects women aged 20–50 with obesity, a demographic growing in prevalence. For certain patients with severe IIH symptoms, it has been a struggle to find appropriate surgical therapies that are FDA-approved and indicated to safely relieve their symptoms.

“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,” said Y. Pierre Gobin, MD, Founder of Serenity Medical and an internationally recognized neurointerventional expert practicing at Weill-Cornell Medicine in New York, NY. “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 Medical reports, the FDA review and approval of the River stent is based on the findings of The River Study: the first multicenter trial of a novel venous stent for the treatment of Idiopathic Intracranial Hypertension (IIH), published in the Journal of Neurointerventional Surgery (JNIS) in February 2025. The study was a prospective, open-label, multi-center, single-arm trial that enrolled 39 subjects at five U.S. centers and aimed to demonstrate the safety and probable benefit of the River stent in patients who are refractory or intolerant to medications. The River Study’s one-year results met the primary safety endpoint with an observed major adverse event rate of 5.4%.ⁱ Improvements were observed in opening CSF pressure, headaches, papilledema, pulsatile tinnitus, visual symptoms, and Quality of Life scores.

“The River Study was groundbreaking as the first-of-its-kind study to evaluate a stent specifically designed for intracranial venous sinuses,” said Adnan Siddiqui, MD, PhD, FAANS, FACS, FAHA, vice chairman and professor of neurosurgery, Jacobs School of Medicine & Biomedical Sciences, and senior author on the paper. “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 Medical has formed a strategic partnership with Radical Catheter Technologies to commercialize the River stent.