VS3 Medical Receives FDA Breakthrough Device Designation for VS3 System to Treat Debilitating Pulsatile Tinnitus

SAN JOSE, Calif.--(BUSINESS WIRE)--VS3 Medical, Inc., a private company developing novel neurovascular implants, today announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Device Designation to its VS3 System. The designation is based on evidence demonstrating that the system has the potential to resolve debilitating pulsatile tinnitus due to venous sinus stenosis.

“We believe the FDA’s recognition of pulsatile tinnitus 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.”

The investigational VS3 System was designed to specifically address the unique properties of the venous anatomy and stenoses. The self-expanding VS3 Stent is engineered to conform to the venous sinus and provide sufficient radial force to open intrinsic and extrinsic stenoses. The VS3 Stent is delivered using a dedicated stent delivery system designed to smoothly navigate the venous sinus anatomy and accurately position the stent upon deployment.

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 provide patients and healthcare providers more timely access to medical devices by expediting and prioritizing FDA review and interaction while maintaining the agency’s rigorous standards for safety and effectiveness.

“The FDA’s recognition of the VS3 System 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.”

About Debilitating Pulsatile Tinnitus

Debilitating pulsatile tinnitus typically presents as a pulse-synchronous rhythmic “whooshing” sound in one or both ears with Tinnitus Functional Index (TFI) score ≥ 54. Pulsatile tinnitus may be a result of abnormal flow in the venous vasculature of the brain, caused by venous sinus stenosis. Symptomatic venous sinus stenosis is characterized by narrowing of the brain’s main drainage sinuses either from extrinsic compression or large arachnoid granulations present in the venous sinus near the ear.

About VS3 Medical, Inc.

VS3 Medical is a privately held medical device company focused on delivering novel neurovascular implants to address symptomatic venous sinus stenosis and overcome the unique challenges of the dural venous sinus anatomy. The company’s VS3 System is an investigational device and is not available for sale. VS3 Medical is funded by premier investors U.S. Venture Partners, Santé Ventures, Gilde Healthcare and Aperture Venture Partners. For more information, please visit www.vs3medical.com and follow VS3 Medical on LinkedIn.