ModifiedCignaPolicy 0574

Implantable cardiac sensors and device-based therapies for heart failure

This Cigna medical coverage policy addresses coverage stance and evidence for several implantable cardiac devices and procedures used in heart failure management, including carotid sinus baroreflex activation devices, left atrial pressure sensors, pulmonary artery pressure sensors, cardiac contractility modulation, and inferior vena cava sensors; it applies to services under Cigna-administered health benefit plans.

Policy Summary

PayerCigna

PolicyImplantable cardiac sensors and device-based therapies for heart failure

Policy CodePolicy 0574

Change TypeFocused review with multiple additions and revisions

Effective Date8/15/2025

Next Review Date10/15/2025

Key ActionObtain prior authorization and submit required clinical documentation confirming device-specific indication elements (NYHA class, prior HF hospitalization or elevated natriuretic peptides, and optimized guideline-directed medical therapy) before implantation.

SourceLink

POLICY UPDATE CHANGES

Added new policy statement for inferior vena cava sensor

Revised policy statement for carotid sinus baroreflex activation device

Added new policy statement for left atrial pressure sensor

Revised policy statement for pulmonary artery pressure sensor

Revised policy statement for cardiac contractility modulation therapy

Removed policy statement and content related to coronary intravascular lithotripsy

5device/procedure types addressed

PMA 2019-08-16BAROSTIM NEO PMA

May 28, 2014CardioMEMS FDA approval

Trek Health ingests and normalizes Transparency in Coverage data and payer policy updates to give provider organizations a clear view of how commercial reimbursement behaves across markets, payers, and services. Our platform transforms raw payer disclosures into structured intelligence that supports contract evaluation, payer negotiations, and service line strategy. By combining market benchmarks with ongoing policy visibility, Trek helps teams identify variability, risk, and opportunity in commercial reimbursement. The result is faster insight, stronger negotiating positions, and more informed financial decisions.

99.2%Cordella PMA safety

486LAPTOP-HF enrollees at termination

801CCM RCT patients (total)

Coverage Criteria and Policy Stance

Device coverage stance

Coverage determinations and stance for devices addressed in this policy:

Carotid sinus baroreflex activation device: Considered experimental, investigational or unproven (CPT 0266T, 0268T; HCPCS C1825), except that the BAROSTIM NEO System has FDA PMA approval (see device-specific indications).

Policy labels general category as experimental despite the BAROSTIM NEO PMA; refer to FDA indication details in clinical background.

Left atrial pressure sensor: Implantation and monitoring considered experimental, investigational or unproven (CPT 0933T).

LAP devices include HeartPOD, Promote LAP, V-LAP; LAPTOP-HF trial terminated due to implant complications.

Pulmonary artery pressure sensor: Implantation and monitoring considered experimental, investigational or unproven (CPT 33289; HCPCS C2624, G0555).

Includes devices such as CardioMEMS and Cordella per overview; document labels as unproven.

Cardiac contractility modulation (CCM): Use considered experimental, investigational or unproven (CPT 0408T, 0915T; HCPCS C1824).

Inferior vena cava (IVC) sensor: Implantation and monitoring considered experimental, investigational or unproven (CPT 0981T).

Device example: NORM System by FIRE1.

BAROSTIM NEO PMA indication

BAROSTIM NEO (CVRx) PMA indication (per FDA and trial evidence):

BAROSTIM NEO FDA indication summary: Indicated for improvement of symptoms, quality of life, 6-minute walk distance, and functional status in patients symptomatic despite guideline-directed medical therapy who are NYHA Class III or Class II with recent Class III, have left ventricular ejection fraction ≤35%, NT-proBNP <1600 pg/mL, and who are not indicated for cardiac resynchronization therapy (CRT).NT-proBNP <1600 pg/mL; LVEF ≤35%; NYHA Class III or recent Class III

Based on FDA PMA (P180050) and BeAT-HF trial enrollment/outcomes.

PA sensor — device-specific indication criteria

Covered when ALL of the following are met (per device indications and trial inclusion):

PA sensor indication: Patient has NYHA Class II or III heart failure per CardioMEMS labeling (CardioMEMS indication expanded to Class II or III) OR NYHA Class III per Cordella labeling as applicable; AND patient has a history of heart failure hospitalization within the prior 12 months and/or elevated natriuretic peptide levels as specified by device labeling or trial inclusion; AND patient is on maximally tolerated guideline-directed medical therapy and clinically stable per device labeling/trial requirements (e.g., stable on GDMT for specified period); AND patient can tolerate required post-implant antiplatelet or anticoagulation per device contraindications (e.g., Cordella contraindication for inability to take DAPT/anticoagulation for one month).as device labeling/trial inclusion

Sources: CardioMEMS PMA (P100045) and supplement, Cordella PMA (P230040), SIRONA2/MONITOR-HF and CardioMEMS randomized trial inclusion criteria and outcomes.

LAP sensor — investigational/unproven

Coverage stance for left atrial pressure (LAP) implantable sensors:

LAP sensor status: Left atrial pressure (LAP) sensors (e.g., HeartPOD, Promote LAP, V-LAP) are investigational or lack clear FDA approval/availability in the U.S.; clinical evidence is limited, trials were small or the randomized LAPTOP-HF trial was terminated for implant-related complications; therefore use is considered investigational pending additional evidence.N/A

LAPTOP-HF terminated after 486 enrollees owing to implant-related complications; V-LAP is described as investigational.

Device candidacy criteria (CardioMEMS and CCM)

Coverage linked to evidence and device labeling; individual criteria mirror trial inclusion and FDA indication elements.

CardioMEMS candidate (evidence-based considerations): Patient characteristics reflected in pivotal trials and PMA labeling: NYHA class II–IV or class II–III (per CardioMEMS labeling expansion), prior heart failure hospitalization within 12 months and/or elevated natriuretic peptides, ability and willingness to transmit daily pulmonary artery pressure readings, and a clinical plan to use hemodynamic data to guide therapy adjustments.as per trial enrollment

Randomized CHAMPION trial, large post-approval registries and MONITOR-HF provide the evidence base; document prior HF hospitalization or elevated NP and capacity for transmissions.

Optimizer (CCM) candidate (per FDA labeling): NYHA class III symptoms despite guideline-directed medical therapy; left ventricular ejection fraction between 25% and 45%; not indicated for CRT; (historically required normal sinus rhythm, but labeling was modified to remove that requirement in 10/2021).LVEF 25-45%

Optimizer Smart System FDA PMA (P180036) and labeling updates; trials used similar EF windows.

Evidence summaries — CCM and IVC sensor

Summary of clinical evidence reported in the document

CCM efficacy and safety findings: Randomized trials and registries report that CCM may improve quality-of-life measures and some exercise parameters in selected patients, but pooled short-term RCT data (four RCTs, 801 patients) show no consistent reduction in heart-failure hospitalizations or mortality; safety concerns include device-related events and a trend toward increased pacemaker/ICD malfunction. Larger and longer-term randomized data are lacking.

Supported by multiple RCTs, registries, and ClinicalTrials.gov summaries.

IVC sensor (FIRE1/Norm) findings: First-in-human FUTURE-HF/I VC sensor study (n=50 implanted, 49 analyzable) demonstrated feasible implantation, excellent agreement of sensor-derived IVC area with CT (mean absolute error 13.53 mm2, R2=0.98), and no device- or procedure-related serious adverse events through 3 months; evidence is early and nonrandomized.

Single-arm feasibility data; additional studies needed to establish clinical effectiveness.

Contraindications for carotid sinus baroreflex activation devices (BAT/BAROSTIM NEO) include: bilateral carotid bifurcations located above the level of the mandible; baroreflex failure or autonomic neuropathy; uncontrolled symptomatic cardiac bradyarrhythmias; carotid atherosclerosis >50% or ulcerative carotid plaques on imaging; and known allergy to silicone or titanium. These contraindications may render a patient unsuitable for implant and should be documented in the clinical record when evaluating candidacy.

The Cordella Pulmonary Artery Sensor System is contraindicated in patients who are unable to take dual antiplatelet therapy or anticoagulation for one month post‑implant. Inability to meet this post‑procedure medication requirement is a safety‑based reason an implant would be inappropriate and may lead to denial of coverage for the procedure.

Although randomized trial data (e.g., CHAMPION and related studies) suggest benefit in some settings, the policy cautions against routine incorporation of wireless pulmonary artery sensor monitoring into clinical practice until additional large, blinded randomized controlled trials replicate these findings. Lack of replicated blinded RCT evidence may limit routine coverage or be a basis for denial when evidence is insufficient.

The following procedures and devices are listed in this policy as Considered Experimental/Investigational/Unproven and associated CPT/HCPCS codes may be denied: CPT 0266T, 0268T and HCPCS C1825 (carotid sinus baroreflex activation device); CPT 0933T (left atrial pressure sensor); CPT 33289 and HCPCS C2624, G0555 (pulmonary artery pressure sensor); CPT 0408T, 0915T and HCPCS C1824 (cardiac contractility modulation); and CPT 0981T (inferior vena cava sensor).

Content and policy language related to coronary intravascular lithotripsy (e.g., Shockwave C2 Coronary IVL System) have been removed from this document in recent focused reviews and are no longer addressed within this policy.

Implantation and monitoring practices vary by device type: carotid sinus baroreflex activation devices (e.g., BAROSTIM NEO) employ an implanted pulse generator and carotid leads to activate the baroreflex; left atrial pressure (LAP) sensors are implanted via transcatheter approaches including transseptal access for intracardiac placement; pulmonary artery (PA) sensors (e.g., CardioMEMS, Cordella) are implanted via right heart catheterization and transmit ambulatory PA pressure data for daily remote monitoring; cardiac contractility modulation (CCM) systems are implanted with pulse generator and transvenous electrodes to deliver non‑excitatory signals; and inferior vena cava (IVC) sensors are transcatheter‑implanted devices intended to measure IVC area/collapsibility paired with an external monitoring system. Device implantation typically includes deployment, calibration, and immediate post‑procedure monitoring as described in device labels and trial protocols, and follow‑up requires documented transmissions and clinical management plans that act on sensor data.

Left atrial pressure (LAP) sensor data are sparse and inconsistent: the multicenter randomized LAPTOP‑HF trial was terminated after 486 enrollees because of a cluster of implant‑related complications, and most available evidence consists of small feasibility studies (e.g., HEARTPOD, V‑LAP) or single‑arm series. Because of the limited and safety‑concerned dataset, LAP sensors are described in the policy as investigational pending further robust randomized evidence.

The policy reiterates a caution about routine use of wireless PA monitoring systems: while single trials and open‑label studies have shown short‑term reductions in heart failure admissions, the document emphasizes that additional large blinded RCT replication is required before routine adoption and that absence of such replicated evidence may influence coverage decisions.

Portions of the document characterize cardiac contractility modulation (CCM) systems and transcatheter implantation of wireless IVC sensors as experimental, investigational, or unproven. These characterizations are reflected in the listing of associated CPT and HCPCS codes under the Considered Experimental/Investigational/Unproven group and may be used as the basis for noncoverage determinations.

Recent focused reviews and revisions to this policy are noted in the document; although the policy was updated with added and revised statements for several device types, the chunks cited do not contain an explicit standalone 'not medically necessary' phrase for every device—rather, the policy records the additions, revisions, and removals (for example, removal of coronary intravascular lithotripsy content) as part of the revision history.

Procedure, CPT and HCPCS Codes

Carotid sinus baroreflex activation device codesmixedExperimental

0266T	Carotid sinus baroreflex activation device (per document)
0268T	Carotid sinus baroreflex activation device (per document)
C1825	HCPCS code referenced for carotid sinus baroreflex activation device

Left atrial pressure sensor codesCPTExperimental

0933T

Implantation and monitoring of a left atrial pressure sensor

Pulmonary artery pressure sensor codesmixedExperimental

33289	Implantation and monitoring of pulmonary artery pressure sensor
C2624	HCPCS code referenced for pulmonary artery pressure sensor
G0555	HCPCS code referenced for pulmonary artery pressure sensor

Cardiac contractility modulation codesmixedExperimental

0408T	Cardiac contractility modulation therapy procedure
0915T	Cardiac contractility modulation therapy procedure
C1824	HCPCS code referenced for cardiac contractility modulation

Inferior vena cava sensor codesCPTExperimental

0981T

Implantation and monitoring of an inferior vena cava sensor

Considered Experimental/Investigational/UnprovenmixedNot Covered

0266T	Implantation or replacement of carotid sinus baroreflex activation device; total system
0268T	Implantation or replacement of carotid sinus baroreflex activation device; pulse generator only
C1825	Generator, neurostimulator (implantable), nonrechargeable with carotid sinus barceptor stimulation lead(s)
0933T	Transcatheter implantation of wireless left atrial pressure sensor for long-term left atrial pressure monitoring
33289	Transcatheter implantation of wireless pulmonary artery pressure sensor for long-term hemodynamic monitoring
C2624	Implantable wireless pulmonary artery pressure sensor with delivery catheter, including all system components
G0555	Provision of replacement patient electronics system for home pulmonary artery pressure monitoring
0408T	Insertion or replacement of permanent cardiac contractility modulation system, including contractility evaluation when performed
0915T	Insertion of permanent cardiac contractility modulation-defibrillation system component(s)
C1824	Generator, cardiac contractility modulation (implantable)

Considered Experimental/Investigational/Unproven - IVC sensorCPTNot Covered

0981T

Transcatheter implantation of wireless inferior vena cava sensor for long-term hemodynamic monitoring

Device PMA identifiersmixed

P100045	CardioMEMS HF System PMA
P230040	Cordella Pulmonary Artery Sensor System PMA
P180036	OPTIMIZER Smart System PMA

Ejection fraction inclusion windows in CCM trials

Common EF ranges cited in randomized CCM trialsExamples include LVEF between 25% and 45% (several trials) and EF ≤35% in other trials; mean EF across pooled RCTs ~29%.

Trial with EF 25–45% inclusionA randomized study enrolled patients with EF ≥25% and ≤45% who were randomized to CCM vs control (n=160).

Trial with EF ≤35% inclusionA larger RCT tested CCM in patients with EF ≤35% (n=428) and identified a subgroup with baseline EF ≥25% who appeared to benefit.

Pooled RCT data EF summaryFour RCTs (801 patients) reported mean ejection fraction 29.1% (±1.22%).

Provider Requirements, Prior Authorization, and Documentation

Documentation Required

Coverage policy governs prior authorization and coding

Coverage policies govern prior authorization and coding: verify benefit plan terms, applicable laws/regulations, and current Coverage Policy criteria before submitting requests. Claims for services without covered codes under this policy will be denied.

Confirm benefit plan language and any state/federal mandates before authorization.
Use most appropriate diagnosis/procedure codes as of date of service.

Prior Authorization

PA sensor prior authorization — confirm device‑specific indication elements

Prior authorization is required for FDA‑approved pulmonary artery (PA) sensor systems. Prior authorization must document that the patient meets the device‑specific indication criteria (e.g., NYHA class, prior HF hospitalization and/or elevated natriuretic peptides, stability on GDMT), and include supporting clinical data.

Clinical and Evidence Background

Device‑based strategies for heart failure target hemodynamic monitoring or neurohormonal reflex modulation to improve symptoms, exercise capacity, and reduce hospitalizations. Examples include baroreflex activation therapy (an implanted pulse generator and carotid leads to stimulate baroreceptors), implantable pulmonary artery pressure sensors that transmit daily ambulatory PA pressure readings (used to guide outpatient management), and cardiac contractility modulation systems that deliver non‑excitatory electrical pulses to augment contractility. Coverage and implantation decisions should reference device labeling, FDA PMA documentation where applicable, and the trial evidence summarized in this policy.

Definitions and Key Terms

Baroreflex activation therapy (BAT) — definition and device description

DefinitionBaroreflex activation therapy (BAT) delivers electrical stimulation to carotid baroreceptors via an implanted pulse generator, external programmer, and leads placed adjacent to the carotid sinus to activate the baroreflex system.

Device componentsSystem comprises an implanted pulse generator (pectorally placed), external programming system, and leads adjacent to the carotid sinus.

Intended effectElectrical stimulation activates the baroreflex to modulate heart rate and blood pressure, aiming to improve HF symptoms, 6-minute walk distance, and quality of life in selected patients.

Left atrial pressure (LAP) sensor — definition

DefinitionLeft atrial pressure (LAP) sensor: an implanted intracardiac remote pressure monitoring device designed to measure left atrial filling pressure to guide therapy and potentially reduce heart failure hospitalizations.

Policy Updates and Material Changes

Policy Summary

PayerCigna

PolicyImplantable cardiac sensors and device-based therapies for heart failure

Policy CodePolicy 0574

Change TypeFocused review with multiple additions and revisions

Effective Date8/15/2025

Next Review Date10/15/2025

SourceLink

On This Page

Document NYHA class and history of HF hospitalization within prior 12 months and/or elevated BNP/NT‑proBNP.

Document optimization and stability on guideline‑directed medical therapy (GDMT) and device therapy status.

Reference device PMA identifier (e.g., CardioMEMS P100045; Cordella P230040) in PA request when applicable.

Prior Authorization

Prior authorization for CCM (Optimizer) — confirm device‑specific indication elements

Prior authorization is required for cardiac contractility modulation (CCM/Optimizer) devices. Authorization must confirm that the patient meets the Optimizer device indications: NYHA Class III symptoms despite GDMT, LVEF between 25% and 45%, not indicated for CRT, and device‑specific labeling considerations (e.g., rhythm requirements per current FDA labeling).

Document LVEF, NYHA class, current rhythm status, prior CRT candidacy evaluation, and trials of optimized GDMT.
Include relevant FDA PMA identifier (OPTIMIZER Smart System P180036 and supplements) in prior authorization documentation.

Prior Authorization

Prior authorization expectation for implantable hemodynamic and CCM devices

For implantable hemodynamic monitors (PA sensors, IVC sensors) and CCM devices, prior authorization should explicitly confirm device indication elements, prior therapy optimization, and review of contraindications. Requests lacking required clinical documentation or using codes listed as experimental/unproven may be denied.

Provide documentation of prior HF hospitalizations, natriuretic peptide levels, NYHA class, and response to GDMT.
Note and document any contraindications (see device labeling) that may preclude implant.
If requesting codes that the policy lists as considered experimental/investigational (see coding groups), include rationale and supporting evidence; absence may result in denial.

Documentation Required

Device PMA references — include PMA identifiers in PA requests

FDA Premarket Approval (PMA) identifiers and regulatory documents are referenced in coverage decisions and prior authorization. When applicable, include the PMA number and, if available, the PMA supplement or approval letter in the authorization request to align the clinical indication with approved labeling.

CardioMEMS HF System PMA P100045 (including supplement P100045/S056 for expanded NYHA II indication).
Cordella Pulmonary Artery Sensor System PMA P230040.
OPTIMIZER Smart System PMA P180036 (and supplements S007/S008 as applicable).
Attach or reference FDA approval letters or summaries when available.

Denial Risk

Contraindication may preclude implant — document device‑specific contraindications

Some device labeling contains contraindications that may preclude implant and must be documented in the prior authorization. For example, the Cordella PA Sensor System is contraindicated in patients unable to take dual antiplatelet therapy or anticoagulation for one month post‑implant.

If the patient cannot safely take required antiplatelet/anticoagulant therapy, document the contraindication and rationale; such patients may be ineligible for implant.
Review device labeling for other device‑specific contraindications prior to authorization.

Denial Risk

Evidence insufficiency risk for routine use — document rationale when evidence is limited

Evidence is evolving; absence of replicated blinded randomized controlled trial data for certain devices means routine use is considered uncertain. Prior authorization should acknowledge evidence limitations and provide clinical rationale when requesting devices for routine care.

Document why the device is expected to benefit this patient given current evidence.
Be aware that lack of robust replicated RCT data may increase risk of denial for routine use.

Denial Risk

IVC sensor experimental coding — implantation considered investigational/unproven

Transcatheter implantation of a wireless inferior vena cava (IVC) sensor and associated codes are listed as experimental/investigational/unproven. Prior authorization for IVC sensor implantation is expected to include clinical trial context or compelling justification; routine coverage is not established.

Code 0981T (transcatheter implantation of wireless IVC sensor) is considered experimental/unproven.
For remote monitoring of an implanted IVC pressure sensor use 0982T; implantation code 0981T remains investigational per policy.

Documentation Required

Regulatory documentation cited — include PMA approvals and note study publication status

Regulatory documentation (PMA summaries, approval letters) cited in the policy should be available to support prior authorization decisions. When relying on newer device approvals, note publication status of supporting studies.

Cordella PMA approval data referenced; the pivotal Cordella study used for PMA approval has not yet been published in peer‑reviewed literature.
Reference FDA PMA documents (links or PMA numbers) in authorization requests when possible.

Step Therapy

Therapy optimization expected before implant — document optimized GDMT and device therapy

Therapy optimization (GDMT and optimal device therapy) is expected before considering implantable hemodynamic monitors or CCM devices. Prior authorization must include documentation of attempts to optimize medical and device therapies and stability criteria per device labeling.

Document duration and components of GDMT, stability period on GDMT (e.g., Cordella requires 30 days of stability), and reasons additional optimization is not feasible.
Document optimization of device therapies (e.g., CRT evaluation) and why patient is ineligible for CRT if considering CCM.

Step Therapy

Stepwise therapy considerations for CCM — ensure CRT ineligible and optimized medical therapy prior to CCM

For CCM, apply stepwise therapy considerations: ensure patients are CRT‑ineligible, have undergone guideline‑directed medical therapy optimization, and meet device labeling LVEF and NYHA criteria prior to authorization. Provide prior CRT evaluation documentation and rationale.

Confirm patient is not a candidate for CRT and document evaluation.
Document LVEF (25%–45%) and NYHA class III despite GDMT.
Include details of prior therapies and why CCM is being considered now.

Device examples & statusDevices include HeartPOD, Promote LAP, and V-LAP; availability and FDA approval in the U.S. are unclear, and V-LAP is described by the manufacturer as investigational.

Clinical contextRationale: ~90% of hospitalized HF patients have pulmonary congestion related to elevated left atrial filling pressure; trials (e.g., LAPTOP-HF) have been conducted but some were terminated due to implant complications.

NYHA class — functional classification

DefinitionNYHA functional classification stratifies heart failure severity into four classes: I (no limitation), II (slight limitation), III (marked limitation), and IV (symptoms at rest).

Class II descriptionSlight limitation of physical activity; symptoms with ordinary activity but none at rest.

Class III descriptionMarked limitation of physical activity; symptoms with less than ordinary activity but none at rest.

RHC — right heart catheterization definition and relation to PA sensor implantation

DefinitionRight heart catheterization (RHC): an invasive catheter procedure inserting a catheter via a large vein to the pulmonary artery to measure pulmonary artery pressures.

Relation to PA sensor implantationImplantation of pulmonary artery (PA) pressure monitoring devices is performed via a RHC; RHC carries significant procedural risks whether for measurement or device implantation.

Typical access sitesCatheter is inserted through a large vein in the neck or groin and advanced into the pulmonary artery.

Cardiac Contractility Modulation (CCM) — definition and mechanism

DefinitionCardiac Contractility Modulation (CCM) is an implantable therapy that delivers non-excitatory electrical pulses during the myocardial absolute refractory period to augment left ventricular contractile performance.

MechanismNon-excitatory CCM signals applied in the absolute refractory period enhance myocardial contractility (strength of contraction) rather than controlling rhythm.

System componentsOptimizer Smart System includes an implantable pulse generator (IPG), programmer (OMNI II), charger, and implantable leads (typically 2 ventricular leads and 1 atrial lead).

Pulmonary artery (PA) pressure sensor (CardioMEMS) — definition and intended use

DefinitionPulmonary artery (PA) pressure sensor (e.g., CardioMEMS) is an implantable wireless sensor that transmits daily pulmonary artery pressure readings to guide heart failure management.

Examples & regulatory statusExamples include the CardioMEMS HF System (FDA PMA P100045, approved May 28, 2014) and the Cordella Pulmonary Artery Sensor System (P230040, June 20, 2024).

Intended useUsed for remote hemodynamic monitoring to inform adjustments in heart failure therapy based on transmitted PA pressure data.

IVC sensor / Norm / FIRE1 — definition and device components

DefinitionIVC sensor (Norm/FIRE1) is an implantable sensor placed in the inferior vena cava intended to measure IVC area and collapsibility for ambulatory congestion management.

Device componentsNorm system components include an implantable sensor, a pusher/loader delivery system, an external hardware unit with a belt, and a web/mobile application for data transmission and provider access.

Regulatory and early evidenceFIRE1 (Norm) received FDA Breakthrough Device designation (Jan 2025); first-in-human FUTURE-HF study (n=50 implants) reported feasibility, excellent agreement with CT, and no device-related serious AEs through 3 months.

Cardiac contractility modulation (CCM) — alternate definition entry

Definition (alternate)Cardiac contractility modulation (CCM) is an implantable system delivering non-excitatory electrical signals to the myocardium to enhance contractility and potentially improve symptoms and quality of life in heart failure with reduced or mid-range EF.

Primary clinical objectivesIntended to improve 6-minute walk distance, quality of life measures, and functional status in selected patients.

Regulatory noteThe OPTIMIZER Smart System received FDA PMA (March 2019) for CCM therapy.

Pulmonary artery pressure sensor — general definition and examples

General definitionPulmonary artery pressure sensor systems are implantable devices (e.g., CardioMEMS, Cordella) used for remote hemodynamic monitoring in chronic heart failure to transmit PA pressure data for clinical management.

Device examplesCardioMEMS HF System (P100045) and Cordella Pulmonary Artery Sensor System (P230040) are device examples with FDA PMA documentation referenced.

Clinical roleDesigned to enable hemodynamic-guided management to reduce heart failure hospitalizations in selected patients by monitoring PA pressures remotely.

Cardiac contractility modulation therapy — definition entry

Definition (therapy-focused)Cardiac contractility modulation therapy delivers non-excitatory electrical pulses during the absolute refractory period via an implantable Optimizer device to augment myocardial contractility.

Target populationProposed for patients with symptomatic heart failure despite medical therapy, including those with reduced or midrange EF and narrow QRS not candidates for CRT.

Reported effectsRCTs and registries report improvements in quality-of-life measures (MLWHFQ) and some exercise parameters; effects on HF hospitalizations and mortality are inconsistent across trials.

Inferior vena cava sensor — emerging technology definition

Emerging technology definitionInferior vena cava (IVC) sensor: an implantable sensor placed in the IVC to monitor IVC area and collapsibility for early detection of volume changes and ambulatory congestion management.

System elementsIncludes implantable sensor, delivery tools (pusher/loader), external belt worn briefly for measurements, and smartphone/web apps for patient and provider interfaces.

Evidence statusEarly first-in-human data (FUTURE-HF) report feasibility and strong agreement with CT measurements; clinical benefit requires further study.