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[2] or transvenous[3] lead placements, which can restrict candidacy or lead to early revisions. Lead-related complication rates can reach up to 11% within five years[4], 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.
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[5]. This method offers a more physiologic[6] 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[7,8,9].
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® 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.”
Enhancing Procedural Confidence and Patient Safety
Michael emphasized how medical simulation minimizes procedural errors and improves procedural confidence. VR-based training allows physicians to refine their skills in a controlled environment, reducing the likelihood of complications during live procedures. The hands-on nature of simulation fosters consistency in technique, ensuring that physicians approach the WiSE® System implantation with greater assurance and expertise. This ultimately leads to better patient outcomes, as physicians can perfect their techniques before treating a real patient.
Furthermore, simulation-driven training has been key in streamlining regulatory and approval processes. Michael highlighted that the ability to conduct extensive preclinical testing using VR significantly strengthened EBR Systems’ regulatory submissions. The detailed insights and procedural refinements from the simulation supported the FDA approval process by providing robust data on procedural safety and efficacy. This level of preparation accelerates compliance for new medical technologies and instills greater confidence among regulatory bodies and healthcare institutions considering the adoption of the WiSE® System.
Adding to this, Tobias Wilde, Sr. Field Training Manager (Europe), EBR Systems, shared,
"Our collaboration with Mentice has played a crucial role in the development and acceptance of the WiSE® System. Our teams relied heavily on the Mentice simulation to stress-test implantation workflows during development. We had early-stage physicians run through the procedure dozens of times, across different anatomical challenges and procedural nuances. The feedback was incredible. They trusted the system before touching a patient; that confidence was a turning point. Having a training solution that enables physicians to gain confidence and proficiency before using our device in real-world scenarios has been a key differentiator.”
Looking ahead, Michael pointed to the growing role of virtual training in shaping the next generation of electrophysiologists. As new technologies emerge, integrating simulation into medical education and certification programs will be critical for ensuring physicians are well-equipped to adopt and implement advanced treatment methods. VR-based learning’s structured and repeatable nature provides a standardized approach to procedural education, essential in a rapidly evolving field like cardiac electrophysiology.
Beyond improving procedural skills and clinical outcomes, VR-based training presents significant cost and operational efficiencies. Michael noted that immersive simulation training minimizes the need for extensive real-world practice cases, reducing the logistical and financial burdens associated with traditional in-person training. This translates into a more streamlined and cost-effective approach to professional education for hospitals and device manufacturers, making the widespread adoption of advanced medical technologies more feasible.
Expanding on the future of virtual training, Erica Adams, Global Director, Mentice, highlighted that the evolving landscape of medical training will likely see an increasing reliance on VR-based simulation, making it a standard component in medical device training and implementation strategies. Adams remarked,
"Partnering with EBR Systems on the WiSE® System has shown how immersive simulation training can help accelerate device adoption while ensuring the highest patient safety and procedural success standards. What impressed me most about EBR was their insistence that simulation should not be optional. They have incorporated it into the clinical pathway, before a single live patient is treated. That level of social responsibility is rare."
With FDA approval now received, the WiSE® System marks a significant advancement in cardiac resynchronization therapy. Offering a leadless solution and integrating advanced simulation-based training, it stands to improve the quality of life for patients with heart failure, while ensuring physicians are fully prepared to deliver optimal care.
Beyond clinical efficacy, both EBR Systems and Mentice are aligned in their commitment to sustainability. Simulation training reduces the carbon footprint associated with live workshops and cadaver-based labs. Moreover, the leadless WiSE® System minimizes future revisions, indirectly contributing to more sustainable cardiac care.
Michael’s insights reinforce how innovation, collaboration, and continuous simulation-driven education are shaping the future of cardiac care. EBR Systems and Mentice continue to push the boundaries of what’s possible, ensuring that advanced technologies reach patients as safely and effectively as possible.
EBR Systems’ partnership with Mentice is just one example of how immersive simulation and advanced device training are transforming patient outcomes in cardiology. From real-world deployment strategies to physician-led success stories, simulation is becoming essential in accelerating innovation and ensuring procedural excellence.
Discover how professional education is evolving, visit our Professional Education page to explore more industry projects, high-fidelity training platforms, and the future of virtual medical education.
References
[1] Mentice Capital Markets Day (CMD) 2024: Time Stamp 1:27:52 Medical Device 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 surface of the heart (epicardium), typically used in pediatric or complex cases where venous access is limited.
[3] Transvenous Lead Placement: Leads are inserted through a vein and guided into the heart chambers, commonly used in adults due to its minimally invasive approach.
[4] Full article: 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 is placed inside the left ventricular chamber to directly stimulate the endocardial (inner) surface, typically used when traditional epicardial or coronary sinus pacing is not feasible or effective.
[6] Physiologic Pacing: A pacing approach that closely mimics the heart’s natural electrical activation, promoting more synchronized and efficient ventricular contraction.
[7] Leadless left ventricular stimulation with WiSE-CRT System – Initial experience and results from phase I of SOLVE-CRT Study (nonrandomized, roll-in phase) - Heart Rhythm
[8] EBR Systems FDA Breakthrough Device Designation for WiSE System
[9] FDA grants Breakthrough Device Designation for the WiSE CRT
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