The U.S. Food and Drug Administration has granted a Breakthrough Device Designation to a new stent system designed to treat severe pulsatile tinnitus, a debilitating condition where patients hear a relentless whooshing sound in sync with their own heartbeat. The designation for the Serenity Shepherd Stent System marks the second major regulatory milestone this year for its developer, Serenity Medical, and could speed the path to market for patients who currently have few options.
Pulsatile tinnitus affects roughly 5 percent of tinnitus patients, but its impact can be devastating. Unlike common tinnitus, which produces a constant ringing, pulsatile tinnitus follows the rhythm of the pulse and cannot be silenced. The condition is often caused by venous sinus stenosis, a narrowing of the brain’s major drainage veins that creates turbulent blood flow audible to the patient. Research has linked the disorder to chronic depression, severe quality of life impairment, and an elevated risk of suicide.
The Shepherd Stent is engineered specifically for the brain’s complex venous anatomy, designed to navigate tight curves in the cerebral sinuses. By propping open narrowed vein segments, the stent restores normal blood flow and eliminates the sound. The FDA’s Breakthrough Device Designation provides an expedited review pathway, including prioritized regulatory engagement, for technologies that show potential to treat life-threatening or irreversibly debilitating conditions. This follows the earlier approval of Serenity’s River Stent System, which received an FDA Humanitarian Device Exemption earlier this year for severe, refractory idiopathic intracranial hypertension, a related condition marked by dangerously high pressure inside the skull.
That earlier approval was supported by the River Study, a prospective multicenter trial published in the Journal of Neurointerventional Surgery. The study enrolled 39 patients at five U.S. centers and met its primary safety endpoint at one year. Researchers reported improvements in opening cerebrospinal fluid pressure, headaches, papilledema, visual symptoms, and quality of life scores. The Shepherd Stent now follows the same clinical development pathway, with the Breakthrough Designation intended to accelerate testing and review.
Serenity Medical is a portfolio company of NeuroTechnology Investors, which also backs a specialized commercial team at Radical Catheter Technologies. That team, built to support neurovascular device launches, will handle physician education and procedural training once the Shepherd Stent receives full approval. The company plans to expand its portfolio of complementary technologies for venous sinus stenosis procedures, targeting a growing population of patients who have exhausted medical therapy.
What happens next: Serenity will now work with the FDA under the Breakthrough program to design and conduct clinical studies aimed at demonstrating the stent’s safety and effectiveness. If successful, the Shepherd Stent could become one of the first dedicated devices for pulsatile tinnitus, offering relief to patients who have long been told their condition is untreatable.