HARRISON, N.Y., June 30, 2026
Serenity Medical announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Device Designation to the Serenity Shepherd Stent™ System for the treatment of severe pulsatile tinnitus associated with venous sinus stenosis. The designation marks the company’s second major FDA regulatory achievement following the Humanitarian Device Exemption (HDE) approval of its River Stent™ System for severe, refractory idiopathic intracranial hypertension (IIH). Designed specifically for the challenging anatomy of the cerebral venous sinuses, the Shepherd Stent™ System is intended to navigate tortuous intracranial vessels while restoring normal venous blood flow in patients suffering from debilitating pulse-synchronous tinnitus.
FDA Breakthrough Designation Accelerates Development
The FDA’s Breakthrough Device Designation is intended for innovative medical technologies that have the potential to provide more effective treatment for life-threatening or irreversibly debilitating conditions. The designation offers prioritized regulatory interactions and an expedited review pathway to accelerate patient access to promising medical devices. Serenity Medical’s Shepherd Stent™ System was recognized for its potential to address severe pulsatile tinnitus, a condition that significantly impairs quality of life and has limited treatment options. The company believes the designation will streamline clinical development while supporting ongoing regulatory engagement as it advances toward commercialization.
Novel Venous Sinus Stent Targets Pulsatile Tinnitus
The Shepherd Stent™ System has been engineered specifically to treat venous sinus stenosis, a narrowing of the cerebral venous sinuses that is increasingly recognized as a major cause of pulsatile tinnitus. Unlike conventional vascular stents, the device is designed to accommodate the tight curves and unique anatomy of intracranial venous structures while maintaining vessel patency. By relieving venous outflow obstruction, the technology aims to eliminate the abnormal blood flow responsible for pulse-synchronous tinnitus, offering a minimally invasive treatment option for patients who often experience chronic psychological distress, depression, sleep disruption, and reduced quality of life.
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Platform Momentum Builds Following River Stent Approval
The latest regulatory milestone builds upon Serenity Medical’s recent FDA HDE approval for the River Stent™ System, the first purpose-built venous stent approved for patients with severe, refractory idiopathic intracranial hypertension. The River Stent’s approval was supported by results from the multicenter River Study, which demonstrated favorable safety outcomes and meaningful improvements in cerebrospinal fluid pressure, headaches, papilledema, pulsatile tinnitus, visual symptoms, and quality of life after one year. Company leadership believes the consecutive FDA milestones validate Serenity’s broader neurovascular platform and strengthen its strategy to expand specialized treatments for venous sinus disorders. Backed by NeuroTechnology Investors (NTI) and supported by Radical Catheter Technologies’ commercial infrastructure, Serenity Medical plans to accelerate clinical development and future commercialization of its growing portfolio of neurovascular devices.
Source: Serenity Medical, press release
