FDA Approves Serenity Medical’s River™ Stent—The First Device Designed For Drug-Resistant Idiopathic Intracranial Hypertension

Serenity Medical, a portfolio company of NeuroTechnology Investors (NTI) and an early leader in treating venous sinus stenosis, announced that the U.S. Food and Drug Administration has granted Humanitarian Device Exemption (HDE) approval for its River stent. This marks the first time the FDA has approved a cerebral venous stent for clinical use. The device is specifically designed for adults with severe idiopathic intracranial hypertension (IIH) who have not responded to medical treatment. The approval represents a major milestone, giving physicians a purpose-built, FDA-approved option for a condition that has remained difficult to treat for many years.

Idiopathic intracranial hypertension is a neurological disorder caused by elevated pressure within the skull. It can lead to persistent headaches, progressive vision loss, and cognitive challenges. The condition most commonly affects women between the ages of 20 and 50 who are living with obesity, a population that continues to increase. For patients with severe symptoms, finding a surgical therapy that is both safe and FDA-approved has long been a challenge.

Dr. Y. Pierre Gobin, Founder of Serenity Medical and a leading neurointerventional specialist at Weill-Cornell Medicine in New York, said that bringing the first venous stent approved for severe, treatment-resistant IIH is deeply meaningful for the team and for patients who have had very few options. He explained that the company was established to solve a problem that has frustrated clinicians and caused significant suffering for many women. He credited years of persistence, close collaboration with investigators, and shared dedication to improving care for making this achievement possible.

The FDA’s approval was supported by data from The River Study, the first multicenter clinical trial designed to evaluate a venous stent specifically engineered for treating IIH. Published in the Journal of Neurointerventional Surgery in February 2025, the prospective, open-label study enrolled 39 patients across five U.S. centers. Its goal was to assess safety and probable benefit in patients who no longer responded to medication or could not tolerate it. After one year, the study met its primary safety endpoint, showing a major adverse event rate of 5.4%. Patients experienced improvements in several key areas, including cerebrospinal fluid pressure, headache severity, papilledema, pulsatile tinnitus, visual symptoms, and overall quality-of-life scores.

Dr. Adnan Siddiqui, vice chairman and professor of neurosurgery at the Jacobs School of Medicine & Biomedical Sciences and senior author of the study, noted that this trial was the first to evaluate a stent created specifically for the intracranial venous sinuses. He emphasized that no other device is currently optimized or FDA-approved for this purpose. He added that the FDA’s acceptance of the data will make this important treatment option available to the wider medical community.

To support commercialization of the River stent, Serenity Medical has entered a strategic partnership with Radical Catheter Technologies. Martin Dieck, Chairman of Serenity Medical and Managing Director at NTI, also serves as Chairman of Radical Catheter Technologies. He explained that Radical has a proven commercialization team experienced in launching innovative neurovascular technologies through strong physician partnerships, advanced clinical training, and direct procedural support. The company is now expanding its reach within the NTI portfolio and beyond, combining its expertise in neurovascular access and delivery systems with new neurotechnology solutions to help drive adoption and widen patient access to transformative care.