Leadless CRT - Wireless Stimulation Endocardially (WiSE)

RE: National Coverage Analysis for WiSE CRT

Writing from my perspective as the Medical Director of a comprehensive cardiac electrophysiology program, I am pleased to submit this formal endorsement for a favorable National Coverage Determination regarding the WiSE® CRT System. This innovative therapeutic option effectively bridges a significant, recognized gap in care for high-acuity heart failure patients who have exhausted traditional methods of cardiac resynchronization.

For individuals facing anatomical impediments, recurrent procedural failures, or a baseline lack of response to standard epicardial left ventricular pacing configurations, this system represents a critical and clinically validated alternative. Achieving effective endocardial resynchronization directly translates to a reduction in the broader clinical and operational strain placed on our healthcare infrastructure. Specifically, this technology minimizes the need for high-risk repeat interventions, reduces preventable heart failure readmissions, and slows down progressive myocardial deterioration.

Furthermore, establishing a standardized national coverage policy is imperative to eliminate regional variances in care availability, thereby ensuring that access to this essential therapy is dictated solely by objective clinical criteria rather than geographic location. I therefore urge CMS to issue a supportive national coverage decision under CAG-00471N to secure equitable access for eligible Medicare beneficiaries.

Thank you for your time, consideration, and dedication to evaluating this important advancement in cardiovascular care.

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As an academic cardiac electrophysiologist with an active clinical and research focus on cardiac resynchronization therapy (CRT), I am writing to express my strong support for establishing national Medicare coverage for the WiSE® CRT System for patients in need of CRT that have failed other means

The system provides left ventricular (LV) endocardial pacing that has been well-established in the literature for many years. When compared to conventional epicardial coronary sinus pacing, endocardial pacing provides a more physiological ventricular activation sequence. Furthermore, this approach offers significantly greater procedural flexibility, allowing operators to select optimal pacing locations tailored to the patient's unique anatomy.

Patients who are unable to receive effective conventional CRT represent a well-defined cohort with a severe, unmet clinical need. This vulnerable population includes individuals presenting with:

• Anatomical Barriers: Failed coronary sinus lead implantation or highly unfavorable venous anatomy.
• Physiological Constraints: Intractable phrenic nerve stimulation or prohibitively elevated pacing thresholds.
• Procedural History: Prior unsuccessful attempts at standard CRT deployment.

Summary of Clinical Evidence

The published data evaluating the WiSE CRT System demonstrate robust, clinically meaningful improvements in ventricular remodeling, heart failure symptomatology, and objective resynchronization outcomes among appropriately selected patients. These contemporary findings are entirely consistent with historical investigations validating the superior hemodynamic and electrophysiologic advantages of endocardial pacing strategies.

Broader Impact on the Medicare Population

The Medicare beneficiary population bears a disproportionate burden of heart failure-related morbidity, mortality, and healthcare resource utilization. Embracing advanced technologies that expand access to successful resynchronization has the dual potential to optimize patient outcomes and significantly reduce downstream expenditures associated with recurrent heart failure readmissions.

Based on the compelling clinical evidence and the pronounced unmet need within this patient population, I strongly support a favorable National Coverage Determination (NCD) under CAG-00471N.

Thank you for your time and consideration of this important matter.

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Centers for Medicare and Medicaid Services
7500 Security Boulevard
Baltimore, MD 21244

RE: Wireless Stimulation Endocardially for Cardiac Resynchronization Therapy System (WiSE CRT)

Submitted Via: CMS.gov

Cleveland Clinic is a not-for-profit, integrated healthcare system dedicated to patient-centered care, teaching, and research. With a footprint in Northeast Ohio, Florida and Nevada, Cleveland Clinic Health System operates 23 hospitals, including a main campus near downtown Cleveland with more than 6,700 staffed beds and 15 Northeast Ohio regional hospitals, as well as 300 outpatient locations. Cleveland Clinic employs over 6,600 physicians and researchers, 17,600 nurses, and 4,300 advanced practice providers. Last year, our system had 15.9 million patient encounters, including 14.4 million outpatient visits and 343,000 hospital admissions and observations. Below is our response to the request for public comments on the WiSE CRT system.

We strongly support the WiSE CRT system and its potential to advance care for patients who may not be adequately served by existing cardiac resynchronization therapy options. In practical terms, the WiSE CRT system offers a way to help coordinate the heart’s pumping action without placing a traditional lead through the coronary sinus, a vein on the surface of the heart that is normally used in conventional CRT. This can allow treatment for patients who otherwise may have few or no realistic CRT options. By addressing an important gap in current care, WiSE CRT offers a meaningful opportunity to improve access to an effective treatment pathway for patients with limited alternatives.

The JAMA Cardiology article, “Leadless Ultrasound-Based Cardiac Resynchronization System in Heart Failure,” reports the SOLVE-CRT study, a prospective, multicenter clinical trial evaluating leadless left ventricular endocardial pacing using ultrasound energy. The study enrolled 183 patients at 36 centers in Australia, Europe, and the United States, including patients who were previously untreatable with conventional CRT because of failed coronary sinus lead placement or lead-related limitations, as well as patients considered high risk for upgrade procedures. These are precisely the types of patients in whom physicians most need an additional therapeutic pathway.

In day-to-day practice, the need is not theoretical. Conventional CRT has transformed the care of many patients with systolic heart failure and electrical desynchrony, including by reducing heart failure hospitalizations and improving survival. However, its success depends on venous anatomy, lead stability, the ability to achieve a satisfactory pacing site, avoidance of phrenic nerve stimulation, and avoidance of elevated pacing thresholds. Put simply, conventional CRT may not work when the patient’s veins do not allow a lead to be placed in the right location, when the lead cannot stay stable, when stimulation irritates a nearby nerve, or when the device must use too much energy to pace the heart effectively. When these factors prevent effective coronary sinus lead placement or make an upgrade unusually risky, patients may remain symptomatic despite otherwise appropriate guideline-directed therapy. The WiSE system offers a method to pace the left ventricular endocardium without requiring a coronary sinus lead, allowing resynchronization to be delivered in patients who would otherwise have limited or no viable CRT option.

The WiSE CRT System is also important for patients who have had prior unsuccessful CRT procedures or who face heightened risks with additional device procedures, including infection risk. In these circumstances, WiSE can give physicians another way to restore resynchronization without repeating the same approach that previously failed or carried excessive risk.

The SOLVE-CRT results are clinically meaningful. The primary safety endpoint showed that 80.9% of patients were free from device- and procedure-related type I complications at six months. In the context of a high-risk population with prior failed therapy, unfavorable anatomy, or challenging upgrade circumstances, this safety profile was better than anticipated. Patients selected for this trial were older, medically complex, and exposed to incremental procedural risk from repeated lead placement or system revision. Analysis of recent real-world practice indicates that procedural risks are much lower and similar to conventional CRT. The reported safety outcome supports the conclusion that the system can be implanted and used with an acceptable risk profile in an appropriately selected patient population.

The results also suggest the treatment may help the heart work better. In the main effectiveness analysis, patients treated with the WiSE CRT System had an average 16.4% reduction in the size of the heart’s left ventricle at the end of a heartbeat after six months. In simple terms, this kind of shrinkage can be a good sign: it may mean the heart is pumping in a more coordinated and efficient way. For people with heart failure who have limited treatment options, this finding is important because it suggests that leadless, ultrasound-based pacing inside the heart may provide real physiologic benefit when standard cardiac resynchronization therapy cannot be used successfully.

From a physician’s standpoint, one of the most important aspects of the WiSE system is that it is not merely a different device configuration; it changes what is possible anatomically. Because the left ventricular electrode can be positioned endocardially and stimulated by ultrasound energy from an implanted transmitter, therapy is not constrained in the same way by the coronary venous anatomy. Endocardial pacing means pacing from inside the heart’s left pumping chamber rather than from a vein on the outside surface of the heart. This may provide a more natural pattern of heart activation and gives physicians more flexibility in choosing the best pacing location for an individual patient. This matters to patients who have unsuitable venous branches, prior lead failures, phrenic nerve stimulation, scar at available epicardial pacing sites, or complex existing device systems. In these cases, the ability to select a more favorable left ventricular pacing site can be the difference between abandoning CRT and offering a plausible path to resynchronization.

An additional clinical benefit is that WiSE may help avoid extraction of existing pacing leads in selected patients. Lead extraction means removing wires that have already been placed in the heart or blood vessels. While extraction is sometimes necessary and appropriate, it can carry added risk, especially for elderly patients and for patients with long-standing leads, multiple prior procedures, blocked veins, infection, or significant other medical conditions. For many Medicare beneficiaries, avoiding lead extraction while restoring effective resynchronization therapy can be a meaningful benefit.

The article appropriately recognizes that this technology should be evaluated in the population for whom it is intended. Patients selected for this trial were older, medically complex and exposed to incremental procedural risk from repeated lead or system revision. Analysis of real world-practice indicates that procedural risks are much lower and similar to conventional CRT.

In clinical experience, the patients who stand to benefit from this technology are often the most difficult CRT cases, including individuals with advanced heart failure symptoms, prior failed coronary sinus lead attempts, lead complications, or device systems that make additional transvenous intervention unattractive. These patients and their families understand that there are risks, but they also understand the consequences of having no effective resynchronization option. A system that can provide CRT without dependence on coronary sinus lead placement is therefore not simply innovative; it is clinically necessary for a defined group of patients.

We would emphasize that the evidence should be interpreted against the realities of this patient population. A high-risk CRT upgrade patient or a patient with failed coronary sinus lead placement is not well served by theoretical access to conventional CRT if the therapy cannot be practically and safely delivered. The SOLVE-CRT study demonstrates that a leadless ultrasound-based left ventricular pacing approach can be implemented across multiple centers, can meet prespecified safety criteria, and can produce measurable improvement in ventricular remodeling. Those findings support the WiSE system as a valuable therapeutic option when conventional approaches are inadequate. The Medicare population bears a disproportionate burden of heart failure illness and healthcare use. Technologies that expand access to effective CRT may improve patient outcomes and may also reduce downstream healthcare costs associated with repeated heart failure admissions.

We support availability of the WiSE CRT System for appropriately selected patients with heart failure who are unable to receive effective conventional CRT or who require high-risk upgrade procedures. The data published in JAMA Cardiology provide a strong basis for that support, and clinical experience reinforces the same conclusion: this system addresses an important unmet need, offers a practical route to resynchronization, and has the potential to improve care for patients who otherwise may be left without a meaningful CRT solution.

Based on the available evidence and the significant unmet need in this patient population, Cleveland Clinic supports favorable coverage under CAG-00471N.

Thank you for conducting a thoughtful process that allows us to provide input on such important issues and for your consideration of our feedback. Should you need any further information, please don’t hesitate to contact me.

Sincerely,

Niraj Varma MD. PhD, FRCP
Professor of Medicine
Director, Cardiac Pacing and Tachyarrhythmia Devices
Cardiac Pacing & Electrophysiology
Heart and Vascular Institute Cleveland Clinic Professor of Medicine

Selected References:
1. Singh J, SOLVE CRT
2. Varma N, Heart Rhythm Society abstract 2026

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July 1, 2025

RE: National Coverage Analysis for Wireless Stimulation Endocardially for Cardiac Resynchronization Therapy System (WiSE CRT)

The American College of Cardiology (ACC) and the Heart Rhythm Society (HRS) represent the physicians and healthcare professionals dedicated to the care of patients undergoing leadless endocardial pacing for cardiac resynchronization therapy (CRT), specifically the Wireless Stimulation Endocardially for Cardiac Resynchronization Therapy (WiSE CRT) system. The Societies strongly support a National Coverage Determination (NCD) under coverage with evidence development (CED). We appreciate the opportunity to comment on the national coverage analysis (NCA).
We note that this NCA uses a device-specific title. Historically, NCDs have been framed using broader, technology-based terminology rather than referring to individual products. Doing so helps support durability and applicability as additional technologies emerge. We recommend adopting a more general, non device specific title to better align with this established approach, with coverage limited to FDA approved devices used in accordance with their labeled indications.

DESCRIPTION OF TECHNOLOGY
At present, the EBR WiSE CRT System is the only commercially available technology labeled for leadless left ventricular endocardial pacing for CRT. However, the absence of other currently available systems does not preclude the future development of similar or alternative technologies.

The WiSE CRT system represents a distinct technological approach compared with conventional CRT and other leadless pacing systems. Traditional CRT relies on transvenous placement of a coronary sinus lead for epicardial left ventricular pacing. In contrast, the WiSE CRT system uses ultrasound-mediated energy to stimulate a leadless electrode implanted directly within the left ventricular endocardium, enabling endocardial pacing without the need for a transvenous lead.
The system is intended for patients in whom conventional coronary sinus lead placement has failed or is not feasible, including those with unfavorable venous anatomy, inability to cannulate the coronary sinus, very high pacing thresholds, lead instability, or unavoidable phrenic nerve stimulation. It is also particularly relevant for patients requiring CRT upgrades in whom transvenous approaches pose increased risk, including those with venous occlusion, prior device infection, multiple existing leads, or limited vascular access.

Endocardial pacing enables greater flexibility in left ventricular pacing site selection and may result in more physiologic ventricular activation compared with epicardial approaches. The system also supports the development of fully leadless CRT strategies, particularly for patients with recurrent infections, limited vascular access, congenital heart disease, or prior complications related to transvenous leads (Niederer et al., Nat Rev Cardiol 2025).

Contemporary implantation of the WiSE CRT system uses a transseptal or transaortic approach for placement of the left ventricular electrode. The system can often be implanted in a single procedure. Left bundle branch pacing can also be achieved from the left side of the ventricular septum using the WiSE CRT system.

PATIENT CRITERIA
The WiSE CRT system is indicated for adult patients who meet criteria for CRT and in whom conventional coronary sinus left ventricular lead placement has failed, is not feasible, or has not achieved expected clinical response due to suboptimal lead location (constrained by epicardial venous anatomy). This includes patients with unfavorable venous anatomy, inability to cannulate the coronary sinus, very high pacing thresholds, lead instability, unavoidable phrenic nerve stimulation, prior device infection, or limited vascular access. It also includes patients requiring CRT upgrades in whom conventional transvenous approaches are considered high risk, such as those with venous occlusion or multiple existing leads. Eligible patients must have or be candidates for a right ventricular pacing device (leadless or transvenous lead) capable of synchronizing with the WiSE CRT system.

These clinical scenarios are especially relevant for Medicare beneficiaries. Many patients have a history of prior device implantation, vascular access limitations, and multiple comorbidities. Older and more frail patients face higher procedural risks during lead extraction and revision, particularly when complicated by venous occlusion or multiple existing leads. For these individuals, the WiSE CRT system offers a crucial alternative when conventional CRT cannot be safely or effectively delivered. In addition, the available epicardial venous branches for left ventricular lead placement may not always provide optimal resynchronization pacing vectors, limited by scar tissue and other factors.

As heart failure is a major cause of morbidity and mortality among Medicare beneficiaries, an optimally implanted CRT system can substantially improve outcomes. Among appropriately selected heart failure patients, CRT provides substantial clinical benefit, with meaningful reductions in mortality and heart failure hospitalizations (Sapp et al., N Engl J Med, 2024; Bristow et al., N Engl J Med., 2004; Linde et al., J Am Coll Cardiol., 2008; Moss et al., N Engl J Med., 2009; Tang et al., N Engl J Med., 2010; Cleland et al., N Engl J Med., 2005). Moreover, CRT is widely regarded as one of the more effective therapies in cardiovascular care, as reflected in guideline-supported indications (Heidenriech et al., J Am Coll Cardiol. 2022). However, despite its well-established benefits, CRT remains underutilized in eligible heart failure patients, underscoring the importance of expanding access to novel CRT technologies for those unable to receive conventional therapy.

For patients who are unable to receive conventional CRT with optimal left ventricular pacing location, the WiSE CRT system offers a novel approach to delivering therapy. It may also benefit selected patients who have not responded adequately to standard CRT by enabling left ventricular endocardial pacing with greater flexibility in pacing site selection (possibly optimizing more physiologic ventricular activation). However, evidence in this population remains limited. The WiSE CRT system can facilitate development of a completely leadless CRT system in patients with recurrent device infections, limited venous access, congenital heart disease, or prior complications related to transvenous leads (Niederer et al., Nat Rev Cardiol, 2025). This is particularly relevant for Medicare patients who are immunosuppressed, receiving hemodialysis, or have extensive indwelling cardiovascular hardware. The system is currently indicated for adult patients who meet criteria for CRT and who either already have, or are candidates for, a right ventricular pacing device capable of synchronizing with the WiSE CRT system. Emerging clinical experience has also described implantation in patients without conventional right ventricular pacing systems, including those with atrial pacing systems. However, this approach remains investigational.

INSTITUTION AND OPERATOR CRITERIA
Procedural settings should be equipped to provide appropriate anesthesia and monitoring based on patient risk and institutional protocols, with the ability to manage procedural complications. Institutions should maintain standardized protocols for patient selection, peri-procedural management, post-implant surveillance, and longitudinal follow-up as is typical for the management of patients with traditional CRT and should participate in ongoing data collection and quality monitoring activities as a condition of coverage.

The pivotal study results suggest the presence of a meaningful operator learning curve associated with this technology (Singh et al., JAMA Cardiology, 2024), which supports the need for appropriate training and procedural experience. Early post-market data from Europe further support the learning curve, with 3 deaths among 90 patients in early registry experience reported in 2020 (Sieniewicz et al., Heart Rhythm, 2020), reinforcing the importance of structured training, proctoring, institutional experience, and ongoing data collection.

Operators should have substantial experience with cardiac implantable electronic devices, including the management of patients indicated for CRT, and should be familiar with the clinical evaluation, programming considerations, and follow-up care associated with CRT. Prior experience implanting or managing CRT systems or CRT upgrade procedures should be considered relevant to operator preparation for use of this technology. Operators should complete technology-specific training prior to independent use, with initial procedures performed under proctoring or equivalent oversight as appropriate.

CLINICAL TRIAL FINDINGS AND CLINICAL CONSIDERATIONS THAT SUPPORT USE OF TECHNOLOGY IN MEDICARE POPULATION & RISK BENEFIT ANALYSIS
For many indicated patients, the comparator is not standard CRT but rather no effective resynchronization therapy. In such cases, the clinical risk includes progressive heart failure, reduced quality of life, recurrent hospitalization, and increased mortality. The pivotal SOLVE-CRT trial (Singh et al., JAMA Cardiology, 2024) demonstrated the safety and clinical benefit of leadless left ventricular endocardial pacing in patients who were unable to receive or had failed conventional CRT. The population studied reflected many characteristics of Medicare beneficiaries, including advanced age and a high level of medical complexity (e.g., one third with diabetes, and more than half with hypertension). These patients often had limited therapeutic options, underscoring the relevance of this technology to the Medicare population.

Medicare beneficiaries, who are older and more frail, face increased procedural risks associated with lead extraction, revision procedures, and repeat transvenous interventions, particularly in the setting of venous occlusion or multiple prior leads. In this context, the WiSE CRT system offers an alternative approach for delivering CRT in patients who are not candidates for conventional therapy. Endocardial left ventricular pacing may provide more physiologic ventricular activation compared with epicardial pacing. The system also avoids placement of additional pacing leads across the tricuspid valve, which can cause or exacerbate tricuspid regurgitation and complicated future tricuspid valve interventions.

Implantation of the WiSE CRT system involves distinct procedural considerations, including left ventricular access and associated periprocedural anticoagulation. These factors should be considered in the context of the alternative treatment options available to this patient population, which often include repeat or complex transvenous procedures in high-risk patients. Additionally, this technology is also particularly relevant for patients who are immunosuppressed, receiving hemodialysis, or have extensive indwelling cardiovascular hardware, where the risk of device infection is elevated.

Recent consensus statements on lead management include a Class I recommendation to consider leadless pacing in a patient-centered, shared decision-making approach (Cha et al., Heart Rhythm, 2026). While leadless left ventricular pacing is not specifically addressed, this recommendation reflects broader recognition of the role of leadless technologies and supports the clinical rationale for expanding access to leadless and non-transvenous approaches in high-risk populations (i.e., patients with prior infections, venous occlusion, or repeated device interventions).

Although the population indicated for the WiSE CRT represents a relatively small population, CRT remains one of the most effective therapies in cardiovascular medicine, with a low number needed to treat. Expanding access to CRT for patients with limited alternatives is therefore of significant clinical importance. Taken together, the benefit-risk profile of the WiSE CRT system is most favorable in a narrowly defined, high-risk population with limited or no viable alternatives. Even modest improvements in CRT delivery, symptom burden, or hospitalization risk may translate into meaningful clinical benefit.

GAPS IN EVIDENCE AND CONDITIONS FOR PROCEDURAL IMPLANT SUCCESS
Initial studies of the WiSE system utilized short-term (6 month) endpoints that were primarily surrogates. Effectiveness outcomes in SOLVE-CRT were directionally encouraging with evidence of reverse left ventricular remodeling, shortening of biventricular activation, and improvements in patient reported quality of life. While this technology shows promise in addressing an unmet clinical need, additional data and clinical considerations are required to determine whether it is reasonable and necessary for the Medicare population. This includes the following:
1) Longer-Term Outcomes: While the short- and medium-term hemodynamic, structural, and functional improvements demonstrated by leadless endocardial pacing are compelling, extended surveillance of longitudinal stability and longer-term effectiveness outcomes are needed. Traditional epicardial and transvenous coronary sinus leads can demonstrate late complications, including insulation failure, lead fracture, and capture threshold changes that manifest years post-implantation.

Similarly, an anchored endocardial micro-stimulator must be rigorously evaluated and longitudinally monitored for chronic threshold stability, battery longevity optimization, and sustained reverse remodeling over a multi-year horizon. Evaluating longer term clinical effectiveness endpoints like heart failure hospitalization and mortality in a contemporary Medicare population is essential to confirm that the early surrogate endpoints findings translate into outcomes that matter to Medicare beneficiaries. Finally, the substantial diversity in the deployment of the WiSE CRT system will be best studied in a clinical setting. This includes evaluation of the system’s performance depending on placement of the LV endocardial stimulator (e.g., lateral wall versus left bundle area) as well as variable pairings with RV pacing mechanisms (e.g., traditional RV apical pacing versus leadless RV pacing).

2) Comparative Effectiveness: A gap remains in the comparative effectiveness between leadless LV endocardial pacing and standard-of-care alternatives. Among those eligible for WiSE CRT, some are not candidates for traditional transvenous lead pacing, while others have failed CRT. Limited data suggest that the WiSE CRT system may be a viable option in selected patients who have not responded to conventional CRT (Wijesuriya et al., J Interv Card, 2025; Sidhu et al., Europace, 2021). At the same time, these findings should be considered within the context of evolving approaches (notably conduction system pacing), which may serve as an alternative or complementary strategy. This is increasingly relevant in the setting of mounting evidence that conduction system pacing from the right heart (His bundle or left bundle branch area) might be a reasonable alternative to traditional CRT among patients with heart failure and electrical dyssynchrony. Analyses comparing WiSE CRT to contemporary strategies (i.e., His-bundle pacing, left bundle branch area pacing/LBBAP, and combinations of these strategies with and without a CS lead) in a typical Medicare population are needed.

3) Important Medicare Subpopulations: More data are required to demonstrate that the WiSE CRT system performs consistently in important subgroups in the Medicare population. For example, the clinical data currently available include small numbers of women who have historically had differential response to CRT compared with men but are under-enrolled in clinical trials. In another example, the average age of patients enrolled in WiSE CRT clinical trials was 68 years, while the average age of a Medicare beneficiary with heart failure is nearly 80. As such, evaluating the performance of the system among older Medicare beneficiaries will also be important. This also applies to patients with multiple advanced medical conditions which may have disqualified them from previous clinical trials. Real-world data can help evaluate whether benefits extend to the most complex Medicare beneficiaries.

4) Procedural Learning Curve: Early clinical data have suggested a learning curve associated with the implant procedure (Sieniewicz, et al., Heart Rhythm, 2020; Okabe, et al. Hearth Rhythm, 2021). Ongoing data collection will further define the relationship between implant volume and outcomes to inform operator training and support.
In conclusion, these evidence gaps highlight the need for ongoing, structured data collection and quality reporting to better characterize real world use, procedural performance, and clinical outcomes, including through incorporation of performance metrics such as observed to expected event rates to support continuous quality improvement.

COVERAGE WITH EVIDENCE DEVELOPMENT REQUIREMENTS
Coverage with Evidence Development (CED) is a powerful mechanism offering significant value to payers, clinicians, and patients. CED frameworks have historically expedited the diffusion of innovative cardiovascular technologies and services to Medicare beneficiaries, while simultaneously promoting timely clinical safety and effectiveness evaluations. The Societies support the use of CED to provide Medicare beneficiaries with prompt access to novel technologies when early evidence suggests (but does not yet convincingly demonstrate) a net benefit for beneficiaries. This support is especially robust for those patients with limited alternative options such as those with heart failure.

CED is well suited to this technology given the presence of identifiable evidence gaps. Ongoing data collection, including the existing WiSE-UP registry, will provide important device-specific insights into safety and effectiveness. Moreover, existing national data infrastructure such as the NCDR EP Device Implant Registry (which incorporates WiSE CRT system procedures), provides a standardized, audited, and scalable platform for prospective data collection under CED. The NCDR framework supports systematic collection of real-world procedural data, patient characteristics, and clinical outcomes across diverse practice settings, enabling assessment of procedural performance, patient selection, and patterns of use.

We encourage CMS to support the use of national registries maintained by professional societies to streamline data collection, promote transparency, and accelerate the development of real-world evidence for emerging technologies such as WiSE CRT. Collection of electrophysiology-relevant endpoints, along with timely reporting of outcomes data, will be essential to inform best practices and guide procedural safety and arrhythmia-related measures.

Thank you for the opportunity to comment on the NCA. The Societies support Medicare coverage of the WiSE System. Please direct any questions or concerns to Amanda Stirling, Associate, Advocacy at (202)375-6553 or astirling@acc.org

Sincerely,

Roxana Mehran, MD, FACC
President, American College of Cardiology

Sana M. Al-Khatib, MD, MHS, FHRS
President, Heart Rhythm Society

REFERENCES
1. Niederer SA, et al. Leadless and endocardial pacing approaches for cardiac resynchronization therapy. Nat Rev Cardiol. 2025.
2. Sapp JL, et al. Cardiac resynchronization therapy and clinical outcomes in heart failure. N Engl J Med. 2024.
3. Bristow MR, et al. Cardiac-resynchronization therapy with or without an implantable defibrillator in advanced chronic heart failure. N Engl J Med. 2004.
4. Linde C, et al. Randomized trial of cardiac resynchronization in mildly symptomatic heart failure patients and in asymptomatic patients with left ventricular dysfunction and previous heart failure symptoms. J Am Coll Cardiol. 2008.
5. Moss AJ, et al. Cardiac-resynchronization therapy for the prevention of heart-failure events. N Engl J Med. 2009.
6. Tang AS, et al. Cardiac-resynchronization therapy for mild-to-moderate heart failure. N Engl J Med. 2010.
7. Cleland JG, et al. The effect of cardiac resynchronization on morbidity and mortality in heart failure. N Engl J Med. 2005.
8. Heidenreich PA, et al. 2022 AHA/ACC/HFSA guideline for the management of heart failure. J Am Coll Cardiol. 2022.
9. Singh JP, et al. Leadless left ventricular endocardial pacing for cardiac resynchronization therapy (SOLVE-CRT trial). JAMA Cardiol. 2024.
10. Sieniewicz BJ, et al. Early experience with the WiSE-CRT system. Heart Rhythm. 2020.
11. Cha YM, et al. Consensus statement on lead management and leadless pacing. Heart Rhythm. 2026.
12. Wijesuriya N, et al. Outcomes of WiSE CRT in patients with failed conventional CRT. J Interv Card Electrophysiol. 2025.
13. Sidhu BS, et al. Leadless left ventricular endocardial pacing in non-responders to CRT. Europace. 2021.
14. Okabe T, et al. Learning curve associated with leadless left ventricular pacing. Heart Rhythm. 2021.

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June 29, 2026

JoAnna Baldwin
Coverage and Analysis Group
Centers for Medicare and Medicaid Services
7500 Security Boulevard
Baltimore, MD 212454

RE: NCA - Wireless Stimulation Endocardially for Cardiac Resynchronization Therapy System (WiSE CRT) (CAG-00471N)

Dear Ms. Baldwin,

On behalf of EBR Systems, I am writing to express our sincere gratitude to the Centers for Medicare & Medicaid Services for opening a National Coverage Analysis (NCA) for the WiSE Cardiac Resynchronization Therapy (WiSE CRT) System under the Transitional Coverage for Emerging Technologies (TCET) pathway. The WiSE CRT is the first and only FDA-approved system for leadless?left ventricular endocardial pacing in CRT. This is a meaningful step forward for the many heart failure patients who currently have no viable treatment alternatives.

CMS’s decision to accept EBR Systems’ TCET nomination and move forward with a formal NCA reflects the agency’s commitment to timely and evidence-based evaluation of innovative technologies. We believe the clinical evidence base for WiSE CRT will demonstrate that this system represents a clinically meaningful advance for an identifiable and high-needs patient population.

We appreciate the diligence and effort of the Coverage Analysis Group in developing the Evidence Preview and providing feedback on the Evidence Development Plan, which will provide additional evidence on patient outcomes for WiSE System patients. EBR Systems looks forward to continued collaboration with CMS towards a positive national coverage determination for WiSE CRT.

Thank you again for your leadership and your continued focus on expanding access to effective, evidence-based therapies for Medicare beneficiaries.

Sincerely,

Justin Crockett
Global Vice President of Marketing and Market Access
EBR Systems

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Re: National Coverage Analysis for the WiSE® CRT System (CAG-00471N)
To Whom It May Concern:
I am a cardiologist and heart rhythm specialist who routinely treats patients with advanced heart failure requiring cardiac resynchronization therapy (CRT).
While conventional CRT has significantly improved outcomes for many patients, a subset of individuals experience unsuccessful coronary sinus lead placement or achieve suboptimal clinical benefit. Other patients are at high risk to consider conventional upgrade to CRT due to need for lead extraction or have contraindications to transvenous leads. For all of these patients, therapeutic options remain limited.
The WiSE CRT System offers an important alternative through leadless left ventricular endocardial pacing. In my professional opinion, this technology addresses a significant unmet clinical need and should be available to appropriately selected Medicare beneficiaries when conventional CRT cannot be effectively delivered. I can also speak from experience in seeing patients with this technology have improved quality of life and less heart failure symptoms.
Establishing national Medicare coverage would help ensure consistent access to care and reduce disparities in treatment availability based on geographic location.
I strongly support Medicare coverage of the WiSE CRT System.
Sincerely,
Soraya Samii, MD PhD MBA

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Dear CMS Review Team:

I am writing in support of national Medicare coverage for the WiSE CRT System.
As an academic electrophysiologist, I routinely treat patients who remain symptomatic despite guideline-directed medical therapy and who are candidates for cardiac resynchronization therapy. Unfortunately, not all patients can successfully receive conventional CRT because of coronary sinus anatomy, venous occlusion, high pacing thresholds, phrenic nerve stimulation, or prior failed lead implantation attempts. In addition, some patients have compelling reasons to have a leadless pacemaker system to reduce their risk of infection (e.g. immunocompromised status, chronic hemodialysis) or have had prior fractures, and they do not have other options for CRT.
Leadless left ventricular endocardial pacing represents a meaningful advancement for these patients. Endocardial pacing has long been recognized as a physiologically attractive pacing strategy due to its ability to recruit the left ventricle in a more natural activation pattern than conventional epicardial coronary sinus pacing. The available evidence supporting the WiSE System demonstrates clinically meaningful improvements in heart failure symptoms, ventricular remodeling, and resynchronization among patients who otherwise have limited therapeutic options. The SOLVE-CRT study demonstrated significant improvements in left ventricular end-systolic volume and clinical status among treated patients. Additionally, prior studies evaluating endocardial pacing have consistently shown favorable hemodynamic and electrical effects compared with conventional pacing approaches.
Importantly, many of the patients who stand to benefit most are Medicare beneficiaries with advanced disease and multiple comorbidities. These are precisely the patients for whom successful CRT can have the greatest impact on quality of life and healthcare utilization.
For these reasons, I support CMS establishing national coverage for the WiSE CRT System for appropriately selected beneficiaries.

Respectfully,
James E. Ip, MD, FACC, FHRS
Professor of Medicine
Director of Cardiac Pacing and Implantable Devices

Weill Cornell Medicine
Division of Cardiology
525 East 68th Street
New York, NY 10065

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