EBR Systems, Inc. (ASX: EBR) has announced the commercial launch of its WiSE Coupler accessory for use in the United States. EBR Systems is a Silicon Valley-based company dedicated to the superior treatment of cardiac rhythm disease by providing more physiologically effective stimulation through wireless cardiac pacing. The WiSE Coupler has been officially listed with the U.S. Food and Drug Administration (FDA) as a Class I, 510(k)-exempt cardiovascular delivery catheter system positioning and stabilisation device.
The WiSE Coupler serves as an optional, single-use procedural accessory, specifically designed to aid the implantation of the WiSE Electrode. It functions by providing mechanical support, coupling the Delivery Sheath and Electrode Catheter handles into a single unit. This integration assists in the precise positioning and stabilisation of the delivery catheter system during the implantation procedure. The device underwent a pilot phase, where it was evaluated in 10 U.S. WiSE implant procedures by both experienced and first-time users, aiming to gather physician input for training and field support materials. John McCutcheon, EBR Systems’ President & Chief Executive Officer, stated, “The development of the WiSE Coupler reflects EBR’s comprehensive focus on execution as we scale the commercial rollout of WiSE.”
Dr Anne Kroman, a Specialist in Electrophysiology Cardiology at the Medical University of South Carolina, commented, “The Coupler is a procedural aid used during the WiSE implant. By keeping the delivery components together and supporting slow, steady electrode advancement, it helps maintain stability and control during a technically important part of the procedure.” In other company news, EBR Systems confirmed it would lodge its Q2 2026 Quarterly Activity Report and Form 10-Q with the ASX on 12 August 2026 AEST.
