Launch of WiSE Coupler Accessory for U.S. Commercial Use

• EBR Systems launches the WiSE Coupler accessory.
• Accessory supports WiSE Electrode implant.
• Listed with the U.S. FDA as Class I, 510(k)-exempt device.
• Used in 10 U.S. WiSE implant procedures.

EBR Systems, Inc. has announced the commercial launch of the WiSE Coupler, an accessory designed to support the implant of the WiSE Electrode. The Coupler is listed with the U.S. Food and Drug Administration (FDA) as a Class I, 510(k)-exempt device. It provides mechanical support during the implantation procedure, aiding in the positioning and stabilization of the delivery catheter system. The Coupler was evaluated in a limited pilot release involving 10 U.S. WiSE implant procedures, with feedback from both experienced and first-time users. The pilot phase was not a clinical investigation and was not designed to evaluate device performance, safety, or effectiveness. The launch of the Coupler complements EBR's ongoing efforts to expand the commercial rollout of the WiSE System in the United States.