Serenity’s River Venous Sinus Stent Studied to Treat Idiopathic Intracranial Hypertension

February 20, 2025—Serenity Medical announced the publication of 1-year results of the RIVER study by Athos Patsalides, MD, et al in Journal of NeuroInterventional Surgery.

According to the company, the trial evaluated the company’s River venous sinus stent for the treatment of idiopathic intracranial hypertension (IIH) in patients who are refractory or intolerant to medications for this condition. The prospective, open-label, multicenter, single-arm trial aimed to demonstrate safety and efficacy of the River stent. The study enrolled 39 patients at five centers in the United States.

The company reported that the study’s 1-year results met the primary safety endpoint with a rate of major adverse event of 5.4%. Significant improvements were observed in opening cerebrospinal fluid pressure, headaches, papilledema, pulsatile tinnitus, visual symptoms, and quality-of-life scores.

Adnan Siddiqui, MD, Vice Chairman and Professor of Neurosurgery, Jacobs School of Medicine & Biomedical Sciences, is the senior author of the study paper.

“We are highly encouraged by the promising results of this first-of-its kind study with a stent specifically designed for intracranial venous sinuses,” commented Dr. Siddiqui in Serenity Medical’s press release. “Stents that are currently used in venous sinus stenting were not specifically developed for this purpose.”

Dr. Siddiqui continued, “As a dedicated venous device, the length, diameter, radial force, and flexibility of the River stent are optimized for the structure and unique mechanical properties of the area we are addressing. We are hopeful that it will offer the opportunity for benefit for patients whose lives are disrupted by IIH and have no options for treatment.”

The company advised that the River stent is currently an investigational device and not commercially available. The RIVER trial was undertaken to obtain humanitarian device exemption approval of the stent. The company is currently working through the approval process with the FDA, noted Serenity Medical.

The press release advised that Serenity Medical is a NeuroTechnology Investor portfolio company focused on the treatment of venous sinus stenosis. The company’s founder is Y. Pierre Gobin, MD, a neurointerventionalist at Weill-Cornell Medicine in New York, New York.