FDA grants Breakthrough Device Designation for the WiSE CRT

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EBR Systems has announced that the US Food and Drug Administration (FDA) has granted Breakthrough Device Designation for its WiSE cardiac resynchronisation therapy (CRT) for the treatment of heart failure. The WiSE (wireless stimulation endocardially) CRT system is designed to improve the heart’s pumping ability by synchronising the left and right ventricles to distribute blood to the lungs and body more effectively.

To regulate precise pacing from within the heart, a press release reports, WiSE uses a unique, wireless electrode the size of a grain of rice. It is implanted in the left ventricle wall during a minimally invasive procedure. This approach provides the cardiologist greater choice of pacing locations, enabling patient-specific customisation of pacing site and may improve CRT response.

The WiSE CRT System is being evaluated in the IDE-approved SOLVE CRT clinical trial. This prospective randomised, double blinded pivotal trial is intended to assess safety and efficacy of WiSE pacing technology in support of FDA approval. The study is enrolling 350 heart failure patients in the USA, Europe, and Australia who have failed to respond to—or are otherwise unable to receive—conventional CRT.

John McCutcheon, president and CEO of EBR systems, comments: “This Breakthrough Device Designation underscores the need for novel solutions for heart failure patients, who have few options today. We are excited that the WiSE System has received Breakthrough Status, which will enhance the review process to bring this important technology to these patients.”


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