Luke System

System Highlights

Continuous Data Collection

The implanted device records cardiac electrical activity 24 hours a day

Data Upload

Data is updated to the LUKE AI Cloud System daily or by event.

AI Analysis

Triple-layered review (AI + history + technician) helps ensure accuracy

Instant Notifications

High-risk events will be notified to the patients and their care team to support timely clinical decision-making.

Clinical Oversight

Alerts generated by the system are reviewed by licensed cardiology professionals who interpret findings in the context of each patient’s clinical profile.

Ischemia detection that leads to early intervention is a game-changer.

Emergency Intervention Workflow

References: ACC/AHA Guidelines | ESC Guidelines

Real-Time Data Transmission

Continuous ECG data and physiologic parameters are relayed in real time—along with geolocation metadata to facilitate rapid triage by emergency medical services (EMS).

Provider Notification

Treating physicians and/or on-call cardiology teams are notified simultaneously, enabling early review and preparation for definitive management.

Protocol-Driven Escalation

Emergency protocols aligned with standard ACS care pathways (ACC/AHA and ESC guidelines) are activated to coordinate pre-hospital and in-hospital teams.

Clinical Rationale

Timely reperfusion is the cornerstone of ST-Segment Elevation Myocardial Infarction (STEMI) management. Current guidelines emphasize first medical-contact-to-balloon (FMC2B) time of ≤90 minutes, or fibrinolytic therapy within ≤30 minutes when PCI is not immediately available. By expediting recognition and initiating parallel notification streams, the LUKE system aims to reduce the interval between ischemic onset, patient identification, and activation of reperfusion therapy teams.

Intended Use Context

The system is designed as a clinical decision-support tool to augment but not replace physician judgment or standard emergency medical services. Notifications are intended to assist in risk stratification and coordination of care within established ACS pathways, including NSTEMI, STEMI, and unstable angina.

Important Disclaimers

• The LUKE Cardiac Monitoring System is an investigational device and has not been cleared or approved by the U.S. Food and Drug Administration(FDA).

• The system is not intended to replace emergency medical care. Patients experiencing symptoms such as chest pain, shortness of breath, dizziness, or fainting should seek immediate medical attention.

• Data analysis and alerts are intended to support, not replace, the judgment of qualified healthcare professionals.

• Performance and safety have not yet been established for widespread clinical use.

• Device notifications and data outputs are intended to support clinician decision-making, not to serve as a sole basis for diagnosis or therapyinitiation.

• Patients experiencing acute chest pain, syncope, or related symptoms should seek immediate emergency care independent of device alerts.

Offices

20 S Sarah St. ,

St. Louis, MO 63108

2900 Carskaddon Ave,

Suite 200, Toledo, OH 43606

(314) 502-9417

info@stlukemed.com

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