What's Happening?
EBR Systems has announced the first patient enrollments in the WiSE-UP Study, a post-approval study evaluating the real-world outcomes of the WiSE System for heart failure patients. The study will follow
over 300 patients across 50 U.S. centers for five years, assessing the performance of the FDA-approved WiSE System, which delivers left ventricular endocardial pacing (LVEP) for cardiac resynchronization therapy (CRT). The first two patients were enrolled at St. Bernards Heart & Vascular Center in Arkansas.
Why It's Important?
The WiSE-UP Study represents a significant advancement in cardiac resynchronization therapy for heart failure patients, particularly those unable to receive traditional CRT. By gathering real-world evidence, the study aims to validate the effectiveness of the WiSE System, potentially leading to improved treatment protocols and patient outcomes. This initiative could pave the way for broader adoption of LVEP technology, offering new hope for patients with limited treatment options.
What's Next?
As the study progresses, EBR Systems will collect data on both short- and long-term outcomes, which could influence future clinical practices and regulatory decisions. Healthcare providers and patients will be closely monitoring the results, which may lead to expanded use of the WiSE System in heart failure treatment. The study's findings could also impact the development of similar technologies, driving innovation in cardiac care.
