Insights from Michael Lee on EBR Systems' Innovation
While effective for many patients, current CRT solutions on the market often face limitations due to lead complications, infection risks, or anatomical challenges. Traditional systems rely on epicardial or transvenous lead placements, which can restrict candidacy or lead to early revisions. Lead-related complication rates can reach up to 11% within five years , and device-related infections or procedural revisions can add substantial costs—averaging over $9,000 per patient in some cases, with severe events such as post-procedural shock leading to costs exceeding $24,000.
While major medical device manufacturers dominate the CRT device market, their offerings rely heavily on transvenous pacemaker leads. The average CRT system lasts 6–10 years; however, replacements due to complications remain significant cost drivers. These replacements pose not only financial burdens on healthcare systems but also increase risks to patient safety.
In contrast, EBR's WiSE ™ System addresses these limitations with a wireless, leadless design, potentially setting a new standard in minimally invasive heart failure therapy.
The WiSE System: A Leadless Advancement in Heart Failure Treatment
EBR Systems, founded to transform the lives of patients suffering from heart failure, has developed the WiSE System to address the limitations of conventional Cardiac Resynchronization Therapy (CRT). Traditional CRT often relies on leads to deliver electrical stimulation to the heart, which can present challenges such as lead placement issues and complications. The WiSE System introduces a leadless approach, utilizing proprietary wireless technology to pace the left ventricle endocardially . This method offers a more physiologic pacing strategy to improve patient outcomes by reducing complications associated with traditional lead-based systems.
The WiSE System consists of an electrode, transmitter, battery, and programmer. The electrode, approximately about the size of a grain of rice, is implanted directly into the left ventricle (LV) and is powered wirelessly by a subcutaneous transmitter that sends ultrasonic energy to stimulate the heart muscle. This unique approach eliminates the need for a lead in the LV, unlike traditional CRT systems, reducing lead-related complications and offering physicians greater flexibility in delivering personalized resynchronization therapy.
Note: The WiSE System is not a general leadless pacemaker but a specialized solution for leadless left ventricular pacing in cardiac resynchronization therapy.
To overcome long-standing challenges in physician training—such as the limitations of traditional animal labs—EBR Systems collaborated with Mentice to develop a fully customized, portable simulation platform tailored to the WiSE® System. The Mentice virtual reality simulator replicates critical implantation workflows, including:
This partnership enables scalable, ethical, and reproducible training that ensures physicians can safely and repeatedly rehearse procedures. Notably, the solution allows EBR to standardize best practices and build physician confidence pre-implantation, solidifying simulation as a cornerstone of their clinical training and regulatory strategy.
The Role of Mentice Simulation in Validating and Training
During the presentation, Michael highlighted Mentice’s advanced simulation technology in validating the WiSE System and training physicians for its deployment. Speaking at Mentice Capital Markets Day in March 2024, Michael underscored how the customized virtual reality-based solution was instrumental in conducting the studies required to obtain FDA approval for the WiSE System.
Michael further explained that the realistic, VR-based training provided by Mentice technology ensures that physicians can practice the implantation procedure in a controlled and risk-free environment, enhancing patient safety and optimizing clinical outcomes. Internal pilot studies showed that simulation-trained physicians experienced a 32% reduction in average procedure time during their first five implants and reported a 45% increase in procedural confidence—key metrics shared in FDA submissions.
Michael further emphasized that simulation allows for comprehensive preclinical testing of the WiSE System, allowing teams to rehearse challenging anatomy and refine procedural strategies. One high-risk case, shared during internal training debriefs, involved a patient with compromised venous access. The implanting physician reportedly used the Mentice VR training to pre-plan the procedure, which helped avoid intraoperative delays. This example illustrates how simulation can be applied to complex clinical scenarios to improve procedural readiness.
Moreover, the simulation platform generated procedural analytics, offering insight into pacing precision, device positioning, and team coordination—all of which contributed to the system’s FDA submission package. Regulators acknowledged this data as evidence of repeatability and clinician readiness, which are critical for first-in-human trials.
Adding further validation to the platform’s clinical realism, Prof. Rinaldi was provided a full overview of the EIS Training Program and system before safely implanting four electrodes using both transseptal and retro aortic approaches. He then tested the simulator’s ability to reflect known complications—such as pericardial effusion and premature detachment—by deliberately deviating from best-practice steps. Prof. Rinaldi expressed strong confidence in the simulator’s ability to replicate procedural challenges with accuracy, reinforcing the EIS as a high-fidelity tool for both standard training and troubleshooting.
According to Dr. Simon James, Consultant Electrophysiologist, South Tees Hospital NHS Foundation Trust and Lead Investigator for FDA Research,
“The use of the Mentice simulation platform in the preclinical phase of WiSE CRT System evaluation has been invaluable,” said Dr. Simon James, Lead Investigator for FDA Research. “It allowed us to optimize our procedural approach ahead of live interventions, significantly enhancing patient safety. The fusion of wireless pacing technology with high-fidelity, realistic procedural training is critical for achieving optimal cardiac resynchronization outcomes." Dr. James continued, "What truly stood out, beyond the technical sophistication, was the responsiveness of the Mentice team. They seamlessly accommodated even our most meticulous customization requests, for example, rotating the ultrasound image by 20 degrees clockwise to precisely replicate in vivo alignment with fluoroscopy and catheter behavior. This level of flexibility elevated the entire simulation experience.”
[1] MenticeCapital Markets Day (CMD) 2024: Time Stamp 1:27:52 MedicalDevice Industry User-story– Michael Lee, Director, EBR Systems, Ireland https://youtu.be/aafuX3Tta18?si=vLJNjfHbztHuHYCh
[2]Epicardial Lead Placement: Leads are surgically attached to the outer surfaceof the heart (epicardium), typically used in pediatric or complex cases wherevenous access is limited.
[3]Transvenous Lead Placement: Leads are inserted through a vein and guided intothe heart chambers, commonly used in adults due to its minimally invasiveapproach.
[4] Fullarticle: Pacemaker complications and costs: a nationwide economic study:https://www.tandfonline.com/doi/full/10.1080/13696998.2019.1652186
[5]Left Ventricular Endocardial Pacing: A pacing technique where the lead isplaced inside the left ventricular chamber to directly stimulate theendocardial (inner) surface, typically used when traditional epicardial orcoronary sinus pacing is not feasible or effective.
[6]Physiologic Pacing: A pacing approach thatclosely mimics the heart’s natural electrical activation, promoting moresynchronized and efficient ventricular contraction.
[7] Leadless leftventricular stimulation with WiSE-CRT System – Initial experience and resultsfrom phase I of SOLVE-CRT Study (nonrandomized, roll-in phase) - Heart Rhythm
[8] EBR Systems FDABreakthrough Device Designation for WiSE System
[9] FDAgrants Breakthrough Device Designation for the WiSE CRT
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