The FDA created this designation and its associated program in 2017 for certain devices providing more effective treatment of life-threatening or irreversibly debilitating diseases or conditions. Under the program, the FDA will provide EBR with priority review and interactive communication.
The WiSE (Wireless Stimulation Endocardially) CRT System is designed to improve the heart’s pumping ability by synchronizing the left and right ventricles to distribute blood to the lungs and body more effectively. To regulate precise pacing from within the heart, 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 customization 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 randomized, double blinded pivotal trial is intended to assess safety and efficacy of WiSE pacing technology in support of U.S. FDA approval. The study is enrolling 350 heart failure patients in the United States, Europe, and Australia who have failed to respond to—or are otherwise unable to receive—conventional cardiac resynchronization therapy (CRT).
“This Breakthrough Device Designation underscores the need for novel solutions for heart failure patients, who have few options today,” said John McCutcheon, president and CEO of EBR Systems. “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.”
Clinical studies featuring the WiSE CRT System and the SOLVE CRT study will be presented at the Heart Failure Society of America meeting between September 13 and 16 in Philadelphia, Pa.