Estella Pulse Generators - BIOTRONIK USA - News

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2 Estella Pulse Generators Technical Manual• BIOTRONIK Home Monitoring allows for improved access to patientdevice data compared to c.onventional in-office follow‐ups sincedevice interrogation is automatically scheduled at regular intervals.Estella provides single and dual chamber pacing in a variety of rateadaptiveand non‐rate adaptive pacing modes. Pacing capability issupported by a sophisticated diagnostic set.The device is designed and recommended for use with atrial andventricular unipolar or bipolar leads having IS‐1 compatible connectors.(Note that IS‐1 refers to the International Standard whereby leadsand generators from different manufacturers are assured a basic fit[Reference ISO 5841‐3:1992]).Estella is designed to meet all indications for bradycardia therapy asexhibited in a wide variety of patients. The family is comprised of fourpulse generators that are designed to handle a multitude of situations.The four pulse generators include:Estella DREstella DR-TEstella SREstella SR-TDual chamber, rate-adaptive, unipolar/bipolarDual chamber, rate-adaptive, unipolar/bipolar,with Home MonitoringSingle chamber, rate‐adaptive, unipolar/bipolarSingle chamber, rate‐adaptive, unipolar/bipolar,with Home MonitoringThroughout this manual, specific feature and function descriptions mayonly be applicable to certain pulse generators of the Estella family.If specified as dual chamber configurations, the descriptions arespecifically referring to Estella DR and Estella DR‐T. If specified as singlechamber configurations, the descriptions are specifically referring toEstella SR and Estella SR-T.
2. IndicationsEstella Pulse Generators Technical Manual 3Rate-adaptive pacing with Estella pulse generators is indicated forpatients exhibiting chronotropic incompetence and who would benefitfrom increased pacing rates concurrent with physical activity.Generally accepted indications for long-term cardiac pacing include,but are not limited to: sick sinus syndrome (i.e. bradycardia-tachycardiasyndrome, sinus arrest, sinus bradycardia), sino-atrial (SA) block,second- and third- degree AV block, and carotid sinus syndrome.Patients who demonstrate hemodynamic benefit through maintenanceof AV synchrony should be considered for one of the dual chamber oratrial pacing modes. Dual chamber modes are specifically indicated fortreatment of conduction disorders that require both restoration of rateand AV synchrony such as AV nodal disease, diminished cardiac outputor congestive heart failure associated with conduction disturbances, andtachyarrhythmias that are suppressed by chronic pacing.
Page 1 and 2: BIOTRONIKEstella Pulse GeneratorsTe
Page 3 and 4: ContentsEstella Pulse Generators Te
Page 5 and 6: Estella Pulse Generators Technical
Page 9: 1. Device DescriptionEstella Pulse
Page 15 and 16: 4. Warnings and PrecautionsEstella
Page 25 and 26: 5. Adverse EventsNOTE:Estella Pulse
Page 35 and 36: 6.2.4 Clinical Study ConclusionsEst
Page 49 and 50: 6.4.4.7 Additional Study ResultsEst
Page 53 and 54: 7. Programmable ParametersEstella P
Page 57 and 58: 7.2.3 Scan HysteresisEstella Pulse
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Estella Pulse Generators Technical
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7.5.3.2 AV HysteresisEstella Pulse
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Figure 13: Automatic Sensor GainEst
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Table 20: Rate DecreaseDecrease inR
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7.11.2.1 PMT Detection and Terminat
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Table 21: Acronyms and TermsCVATMTe
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9. Other Functions/FeaturesEstella
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10. Product Storage and Handling10.
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11. Lead ConnectionEstella Pulse Ge
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12. Follow-up Procedures12.1 Genera
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Table 33: Nominal Pulse Generator L
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14. ExplantationEstella Pulse Gener
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AV Repetitive Hysteresis (Dual cham
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Periodic TransmissionOff, 30, 60, 9
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ParameterEstella Pulse Generators T
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16. Order InformationPulse Generato
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The AAI mode is conditionally indic
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Manufactured by:BIOTRONIK SE & Co.
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Estella Pulse Generators - BIOTRONIK USA - News

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