FDA Grants Breakthrough Device Designation to VS3 System for Pulsatile Tinnitus Caused by Venous Sinus Stenosis
核心洞察
VS3 Medical received FDA Breakthrough Device Designation for its investigational VS3 System (搜索), a neurovascular implant intended to resolve debilitating pulsatile tinnitus (搜索) caused by venous sinus stenosis (搜索).
The designation rests on evidence that the self-expanding VS3 Stent (搜索) can address the underlying anatomical causes of symptomatic venous sinus stenosis (搜索), a narrowing of the brain's main drainage sinuses.
Debilitating pulsatile tinnitus (搜索) presents as a pulse-synchronous whooshing sound in one or both ears, with a Tinnitus Functional Index score of 54 or higher.
VS3 Medical, Inc. (搜索) announced that the U.S. Food and Drug Administration (搜索) has granted Breakthrough Device Designation to its VS3 System (搜索), an investigational neurovascular implant designed to resolve debilitating pulsatile tinnitus (搜索) caused by venous sinus stenosis (搜索). The company said the designation is based on evidence demonstrating that the system has the potential to resolve the condition.
The VS3 System (搜索) was designed to address the specific properties of venous anatomy and stenoses. Its self-expanding VS3 Stent (搜索) is engineered to conform to the venous sinus and provide sufficient radial force to open intrinsic and extrinsic stenoses. The stent is delivered through a dedicated delivery system intended to navigate the venous sinus anatomy smoothly and position the stent accurately upon deployment.
Anatomy as the Treatment Target
Symptomatic venous sinus stenosis (搜索) is characterized by narrowing of the brain's main drainage sinuses, either from extrinsic compression or from large arachnoid granulations present in the venous sinus near the ear. Pulsatile tinnitus (搜索) may result from abnormal flow in the venous vasculature of the brain caused by that stenosis.
Debilitating pulsatile tinnitus (搜索) typically presents as a pulse-synchronous rhythmic whooshing sound in one or both ears, with a Tinnitus Functional Index (TFI) score of 54 or higher.
"We believe the FDA's recognition of pulsatile tinnitus (搜索) as a debilitating condition is another positive step towards more timely diagnosis and appropriate treatment pathways for patients," said Matthew Amans, M.D., M.S., professor of radiology and neurological surgery at University of California, San Francisco, and founder of VS3 Medical. "Advances in imaging have significantly improved our understanding of the intracranial venous anatomy, enabling the development of technologies like ours that are designed to specifically address the underlying anatomical causes of symptomatic venous sinus stenosis (搜索)."
Regulatory Pathway
The FDA Breakthrough Devices program is limited to certain medical devices that have the potential to provide more effective treatment or diagnosis of life-threatening or irreversibly debilitating diseases or conditions than current options. The program is intended to give patients and healthcare providers more timely access to medical devices by expediting and prioritizing FDA review and interaction while maintaining the agency's standards for safety and effectiveness.
"The FDA's recognition of the VS3 System (搜索) as a Breakthrough Device is an important milestone for the VS3 team," said Thomas C. Wilder, chief executive officer of VS3 Medical. "We look forward to collaborating with the agency as we continue to generate evidence supporting the safety, effectiveness and clinical value of the system for this important patient population."
Development Status
VS3 Medical is a privately held medical device company focused on delivering neurovascular implants to address symptomatic venous sinus stenosis (搜索) and the challenges of the dural venous sinus anatomy. The VS3 System (搜索) remains an investigational device and is not available for sale. The company is funded by U.S. Venture Partners, Santé Ventures, Gilde Healthcare and Aperture Venture Partners.