Serenity Medical has secured Breakthrough Device Designation from the U.S. Food and Drug Administration (FDA) for its Serenity Shepherd Stent™ System, reinforcing its progress in the development of neurovascular devices for venous sinus disorders.
The designation covers the use of the stent system for treating severe pulsatile tinnitus linked to venous sinus stenosis.
The Shepherd Stent System has been engineered to navigate the challenging structure of the cerebral venous sinuses and support the treatment of narrowed veins that contribute to the condition.
Pulsatile tinnitus is a serious neurological disorder in which patients experience a persistent sound that matches the rhythm of their heartbeat.
The condition can disrupt everyday life and is associated with reduced quality of life and psychological distress.
The latest regulatory achievement builds on Serenity Medical’s earlier Humanitarian Device Exemption (HDE) approval for its River Stent, which was authorised this year for the treatment of idiopathic intracranial hypertension (IIH).
Together, these milestones strengthen the company’s portfolio of technologies targeting venous sinus stenosis and support the continued expansion of its neurovascular innovation pipeline.
The FDA’s Breakthrough Device programme is designed to speed the development and review of medical devices that may provide significant clinical benefits for patients with life-threatening or permanently debilitating conditions.
Through this designation, Serenity Medical will receive enhanced interaction with the FDA during the regulatory process, helping to accelerate clinical development and advance the availability of the Shepherd Stent System for patients with severe pulsatile tinnitus.
