Angel Medical Systems
Developer of an implantable intracardiac monitoring and patient-alerting system for early detection of acute coronary syndrome (ACS) events. Focus areas include continuous intracardiac electrogram acquisition, machine-learning derived patient-specific ST-shift detection, randomized pivotal clinical trials with independent adjudication, regulatory authorizations for implantable cardiac devices, and payer engagement for coding and reimbursement.
Industries
Nr. of Employees
small (1-50)
Angel Medical Systems
Eatontown, NJ (city listed in press releases)
Products
Implantable intracardiac monitoring and alerting system
An implantable monitoring device connected to an active-fixation intracardiac sensing lead that continuously acquires intracardiac electrograms, applies machine-learning derived patient-specific ST-shift detection, stores triggered electrograms for clinician review, and provides internal vibration plus external auditory/visual patient alerts.
Implantable intracardiac monitoring and alerting system
An implantable monitoring device connected to an active-fixation intracardiac sensing lead that continuously acquires intracardiac electrograms, applies machine-learning derived patient-specific ST-shift detection, stores triggered electrograms for clinician review, and provides internal vibration plus external auditory/visual patient alerts.
Services
Support for physician and facility reimbursement processes including coding guidance, coverage/payment support, and prior authorization assistance.
Onsite and remote clinician education and procedural support covering implantation technique, device programming, follow-up interrogation, and use of device-derived electrogram data in clinical pathways.
Support for randomized pivotal trials including site oversight, independent ECG and angiographic core labs, clinical events adjudication, and adaptive statistical monitoring.
Analysis of post-approval device performance metrics, preparation of scientific presentations and publications, and evidence-generation to inform clinical adoption.
Support for physician and facility reimbursement processes including coding guidance, coverage/payment support, and prior authorization assistance.
Onsite and remote clinician education and procedural support covering implantation technique, device programming, follow-up interrogation, and use of device-derived electrogram data in clinical pathways.
Support for randomized pivotal trials including site oversight, independent ECG and angiographic core labs, clinical events adjudication, and adaptive statistical monitoring.
Analysis of post-approval device performance metrics, preparation of scientific presentations and publications, and evidence-generation to inform clinical adoption.
Expertise Areas
- Implantable intracardiac monitoring and patient alerting
- Machine learning for cardiac signal analysis and adaptive thresholding
- Randomized, multi-center clinical trial design and execution
- Bayesian adaptive trial design and interim analysis
Key Technologies
- Intracardiac electrogram (iEGM) monitoring
- Continuous ST-segment deviation detection
- Machine learning–based personalized thresholding
- IS-1 compatible intracardiac sensing lead integration
News & Updates
Presentation/participation at SCAI 2024 scientific meeting.
Attendance/participation at Heart Rhythm 2024 conference.
Exhibit/participation at TCT 2024 conference.
Randomized multicenter trial evaluating an implantable intracardiac monitor with real-time alarms to reduce pre-hospital delay for ACS events; reports on detection-to-presentation time, PPV, and safety.
Multicenter randomized ALERTS trial results showing device safety, analyses of detection-to-presentation times, and expanded analyses of positive predictive value and false-positive rates.
U.S. FDA granted premarket approval for an implantable real-time cardiac monitor indicated to detect ACS events.
Presentation/participation at SCAI 2024 scientific meeting.
Attendance/participation at Heart Rhythm 2024 conference.
Exhibit/participation at TCT 2024 conference.
Randomized multicenter trial evaluating an implantable intracardiac monitor with real-time alarms to reduce pre-hospital delay for ACS events; reports on detection-to-presentation time, PPV, and safety.
Multicenter randomized ALERTS trial results showing device safety, analyses of detection-to-presentation times, and expanded analyses of positive predictive value and false-positive rates.
U.S. FDA granted premarket approval for an implantable real-time cardiac monitor indicated to detect ACS events.