EBR: Positive results from first-in-human completely leadless CRT in the US

 EBR Systems, Inc. (ASX:EBR), the medical device company developing wireless cardiac pacing systems, is proud to announce that positive results from the first completely leadless cardiac resynchronization therapy (CRT) in the United States have been published in The Journal of American College of Cardiology (JACC).

The positive results published in JACC are based on a 1-year follow-up of the first-in-human implantation in the US of totally leadless CRT pacing utilizing the Micra™ leadless pacing system in the right ventricle in conjunction with EBR's investigational WiSE® CRT Electrode in the left ventricle of the heart. At 12-months, the patient showed improved heart failure symptoms (NYHA Class III to II), no recurrent heart failure-related hospitalization, a reduction in QRS duration, and an improvement in left ventricular ejection fraction (LVEF) from 30% to 65%.

This first use in the US of the WiSE CRT System as a first-line therapy is a future market expansion opportunity for EBR. The initial addressable market of $2.6 billion is focused on treating patients who had previously failed CRT and by treating new CRT patients, the addressable market could increase to $6.8 billion.

Based on the patient's health complications and risks, the implantation of EBR's investigational WiSE CRT System alongside Medtronic's Micra received requisite approval from the Institutional Review Board (IRB) and U.S. Food and Drug Administration (FDA) on compassionate grounds.

"Our research findings published in The Journal of the American College of Cardiology demonstrate the first reported application of this uniquely versatile option of CRT use in the United States," said Dr Dinesh Sharma, MD, the implanting physician and Section Head, Cardiac Electrophysiology at Naples Heart Institute, Florida. "The positive results witnessed during the one-year follow-up of the implantation, suggests that a broader cohort of patients can potentially reap the benefits of completely leadless resynchronization as these leadless pacemakers advance."

https://www.biospace.com/article/releases/positive-results-from-first-in-human-completely-leadless-crt-in-the-us-published-in-the-journal-of-the-american-college-of-cardiology/