August | 2026
Acandis Receives Regulatory Approval to Launch SONIC Pivotal Clinical Investigation Evaluating the SILANCE® Stent for the Treatment of Idiopathic Intracranial Hypertension (IIH)
Acandis Receives Regulatory Approval to Launch SONIC Pivotal Clinical Investigation Evaluating the SILANCE® Stent for the Treatment of Idiopathic Intracranial Hypertension (IIH)
Pforzheim, Germany – 5 August 2026
Acandis GmbH, a leading Germany medical technology company specialising in devices for neurovascular interventions, announced today that it has received approval from the German Federal Institute for Drugs and Medical Devices (BfArM) to initiate the SONIC (ClinicalTrials.gov Identifier: NCT07561268) clinical investigation in Germany.
The pivotal, prospective, multicentre clinical investigation will evaluate the SILANCE® Stent for the treatment of patients with idiopathic intracranial hypertension (IIH) associated with symptomatic cerebral venous sinus stenosis. The first site initiation is scheduled for September 2026.
A total of 99 patients will be enrolled across approximately 20 European neurovascular centres with an emphasis on Germany. The study is led by PD Dr. med. Hannes Nordmeyer, an internationally recognised interventional neuroradiologist and expert in the treatment of cerebral venous sinus stenosis.
“The approval of the SONIC study represents another important milestone in Acandis’ commitment to advancing neurovascular innovation,” said Dr. Andreas Schüßler, Founder and CEO of Acandis GmbH.
“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 idiopathic intracranial hypertension, 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 venous sinus stenting technologies and generating the clinical evidence needed to establish this emerging field of neurovascular therapy.”
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