The US Food and Drug Administration (FDA) has granted Serenity Medical’s River stent a humanitarian device exemption (HDI), making it the first cerebral venous stent approved by the agency for the treatment of severe idiopathic intracranial hypertension (IIH).
Caused by elevated cranial pressure, IIH typically leads to chronic headaches, vision loss, and cognitive impairment. Disproportionately affecting women aged 20–50 with obesity, Serenity highlights that in severe IIH cases, finding appropriate surgical therapies that are FDA-approved and indicated to safely relieve patients’ symptoms has been difficult.
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Under the HDI, Serenity’s River stent is approved for use in adult patients with IIH with significant stenosis who have proven resistant or intolerant to medications. The stent is designed to hold open narrowed veins in the brain to improve blood drainage and reduce pressure to alleviate IIH symptoms. It is primarily intended for use in patients with severe headaches who have failed to respond to six months or more of medical therapy such as attempted weight loss, or for patients who have had visual symptoms or visual signs that are vision-threatening despite medical therapy.
Serenity’s founder, Y. Pierre Gobin, commented: “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.”
The FDA’s HDI was granted on the basis of findings from Serenity’s River study. The 39-subject study demonstrated the safety and benefit of the River stent in patients who were refractory or intolerant to medications.
At one year, River met the study’ primary safety endpoint, with an observed major adverse event (AE) rate of 5.4%. Improvements were observed in opening cerebrospinal fluid (CSF) pressure, headaches, papilledema, pulsatile tinnitus, visual symptoms, and patients’ Quality of Life (QoL) scores.
Adnan Siddiqui, vice chairman and professor of neurosurgery, Jacobs School of Medicine & Biomedical Sciences, and senior author on the study’s ensuing paper, published in the Journal of Neurointerventional Surgery (JNIS) in February 2025, commented: “There is no other stent that is optimised 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.”
