Acandis has announced that it has received approval from the German Federal Institute for Drugs and Medical Devices (BfArM) to initiate the SONIC study in Germany. This pivotal, prospective, multicentre clinical investigation will evaluate the company’s Silance stent for the treatment of patients with idiopathic intracranial hypertension (IIH) associated with symptomatic cerebral venous sinus stenosis, with the first site initiation scheduled for September 2026.
“Venous sinus stenting [VSS] has become an increasingly important treatment option for patients suffering from IIH,” said Hannes Nordmeyer (Städtisches Klinikum Solingen, Solingen, Germany), who is leading the SONIC study. “The Silance stent has been specifically engineered for this indication and combines a low-profile delivery system with a design tailored to the unique anatomy of the cerebral venous sinuses. We believe this dedicated approach has the potential to further improve procedural safety and treatment outcomes.”
The SONIC study is designed to evaluate the clinical benefit, performance and safety of the Silance stent—described by Acandis as a novel, self-expanding nitinol stent specifically developed for VSS. Acandis also notes that the device’s laser-cut, closed-cell design, atraumatic stent ends and low-profile 3Fr delivery system are designed to facilitate safe navigation through the tortuous venous anatomy while minimising procedural risks.
A total of 99 patients will be enrolled in SONIC across approximately 20 European neurovascular centres with an emphasis on Germany. The study’s primary clinical endpoint is the disappearance or significant improvement of IIH-related symptoms six months after treatment, while the primary performance endpoint evaluates the reduction of the transstenotic venous pressure gradient following stent implantation. Safety will be assessed via the rate of major adverse events.
According to Acandis, recruitment is expected to continue over the course of approximately 24 months, followed by a 12-month clinical follow-up period.
“The approval of the SONIC study represents another important milestone in Acandis’s commitment to advancing neurovascular innovation,” said Andreas Schüßler, founder and chief executive officer (CEO) of Acandis. “Together with our ongoing RESOLVE study evaluating the Sirex stent for the treatment of pulsatile tinnitus, the SONIC study expands our clinical research portfolio to encompass the two major clinical manifestations of symptomatic cerebral venous sinus stenosis. While RESOLVE focuses on pulsatile tinnitus, SONIC addresses IIH, making Acandis the first company in Europe to initiate dedicated pivotal clinical investigations for both major indications associated with symptomatic cerebral venous sinus stenosis. This underscores our commitment to pioneering dedicated VSS technologies and generating the clinical evidence needed to establish this emerging field of neurovascular therapy.”
