Estella Pulse Generators - BIOTRONIK USA - News

1. Device DescriptionEstella Pulse Generators Technical Manual 1Estella is a multi-programmable, dual chamber pulse generator withrate-adaptive pacing. Rate-adaptation is achieved through motionbasedpacing via a capacitive accelerometer.For standard motion-based rate-adaptation, the Estella is equippedwith an accelerometer located within the pulse generator. This sensorproduces an electric signal during physical activity of the patient. If arate-adaptive (R) mode is programmed, then the accelerometer sensorsignal controls the stimulation rate.Estella also employs Home Monitoring technology, which is anautomatic, wireless, remote monitoring system for management ofpatients with pulse generators. With Home Monitoring, physicians canreview data about the patient’s cardiac status and pulse generator’sfunctionality between regular follow-up visits, allowing the physician tooptimize the therapy process.BIOTRONIK conducted the TRUST study to evaluate the safety andeffectiveness of Home Monitoring. Refer to Section 6.4 for detailsregarding the study design and results. With the TRUST study, BIOTRONIKwas able to show the following with regards to Home Monitoring:• BIOTRONIK Home Monitoring information may be used as areplacement for device interrogation during in-office follow-upvisits.• A strategy of care using BIOTRONIK Home Monitoring with officevisits when needed has been shown to extend the time betweenroutine, scheduled in-office follow-ups of BIOTRONIK implantabledevices in many patients. Home Monitoring data is helpful indetermining the need for additional in-office follow-up.• BIOTRONIK Home Monitoring-patients—who are followed remotelywith office visits when needed—have been shown to have similarnumbers of strokes, invasive procedures and deaths as patientsfollowed with conventional in-office follow‐ups.• BIOTRONIK Home Monitoring provides early detection ofarrhythmias.• BIOTRONIK Home Monitoring provides early detection of silent,asymptomatic arrhythmias.• Automatic early detection of arrhythmias and device systemanomalies by BIOTRONIK Home Monitoring allows for earlierintervention than conventional in-office follow-ups.