Sonorous Neurovascular has announced that the US Food and Drug Administration (FDA) has granted a Breakthrough Device designation to its BosSTENT device, which is described by the company as the “first” braided, self-expanding cerebral venous stent intended to treat debilitating pulsatile tinnitus.
“This FDA Breakthrough Device designation is a major milestone for Sonorous Neurovascular and, most importantly, for the patients suffering from debilitating pulsatile tinnitus,” said Sonorous president Joel Harris. “The BosSTENT represents years of focused innovation to deliver an on-label, minimally invasive solution that normalises venous haemodynamics and has the potential to dramatically improve quality of life for individuals with pulsatile tinnitus. We are grateful for the FDA’s recognition and look forward to collaborating closely under this programme to accelerate access to treating patients.”
A press release from Sonorous avers that symptomatic venous sinus stenosis is a primary contributor to debilitating pulsatile tinnitus, also noting that current treatment options “remain limited for many patients”.
Key features of the BosSTENT—a purpose-built, braided, self-expanding stent with a proprietary design—include optimal radiopacity, enhanced visibility, ‘resheathability’ for precise deployment, and “excellent” conformability in complex anatomies, according to Sonorous.
The recently announced US FDA Breakthrough Device designation follows promising early clinical experiences, including first-in-human uses, and ongoing studies evaluating the safety and performance of the BosSTENT in treating pulsatile tinnitus as well as other symptoms of venous sinus stenosis, the release continues.
Sonorous says it is advancing clinical trials and regulatory pathways to bring the BosSTENT to patients in the USA “and beyond”.
