FDA approves first leadless left ventricular pacing device

SUNNYVALE, Calif. - EBR Systems, Inc. (ASX: EBR), a $12.59 billion market cap medical device company with a "GOOD" financial health rating according to InvestingPro, announced today that the U.S. Food and Drug Administration (FDA) has granted approval for its WiSE® System, a novel cardiac resynchronization therapy (CRT) device designed to treat heart failure. This system is the first and only to provide leadless left ventricular endocardial pacing (LVEP), a technique that mimics the heart’s natural conduction pathway more closely than traditional CRT devices.

The WiSE System is geared toward heart failure patients who are ineligible for conventional CRT due to anatomical challenges, previous lead failures, or high procedural risks associated with lead placement. It also extends the option of CRT to patients with existing leadless pacemakers who could not previously upgrade to conventional CRT.

According to the press release, the WiSE System has shown positive results in clinical trials. The SOLVE-CRT study reported a 16.4% reduction in left ventricular end-systolic volume, a significant indicator of heart function improvement, and a reduction in QRS duration by an average of 39 milliseconds, suggesting better electrical resynchronization. Analysts maintain a Strong Buy consensus on EBR Systems, reflecting confidence in the company’s innovative technology and market potential. Over half of the patients improved by at least one New York Heart Association (NYHA) class, and another 40% remained stable.

The device operates by syncing with existing pacemakers, ICDs, or CRT devices through a subcutaneous ultrasound transmitter, which powers an implanted electrode in the left ventricle, eliminating the need for leads.

John McCutcheon, President and CEO of EBR Systems, expressed optimism for heart failure patients who previously had no treatment options, highlighting the device as a significant achievement for the company and a new tool for electrophysiologists.

The WiSE System is compatible with Medtronic’s Micra leadless pacemaker, with testing underway to qualify its use with Abbott’s Aveir leadless pacemaker.

This approval signals a new chapter for EBR Systems, transitioning from a pre-commercial phase into a high-growth medical device company. With strong fundamentals including a healthy current ratio of 2.04 and revenue growth of 8.13%, the company appears well-positioned for commercial expansion. The information for this article is based on a press release statement from EBR Systems and financial data from InvestingPro, which offers comprehensive analysis and additional insights through its detailed Pro Research Reports, available for over 1,400 US stocks.

In other recent news, Eletrobras has announced a proposed merger with its subsidiary, Eletrobras Participações S.A. – Eletropar. This merger, which has already received approval from the Board of Directors, aims to simplify Eletrobras’s corporate structure and improve governance. Shareholders of Eletropar will receive 0.80 common shares of Eletrobras for each share of Eletropar, a more favorable exchange ratio than initially appraised. The merger is expected to cost approximately R$1.5 million, covering professional services and administrative expenses, and it does not require approval from Brazilian or foreign authorities. Eletropar will be dissolved post-merger, and Eletrobras anticipates enhanced decision-making processes as a result. Shareholders of Eletropar will have the right of withdrawal based on the book value of equity as of December 31, 2023. Eletrobras has made all necessary documentation available for shareholders to exercise their voting rights at the upcoming General Meeting. The company has committed to keeping shareholders and the market informed about the merger’s progress.

This article was generated with the support of AI and reviewed by an editor. For more information see our T&C.