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OPTIMIZER SmartImplantable Pulse GeneratorINSTRUCTIONS FOR USEFederal (US) law restricts this device to sale by or on the order of a physicianPart No.: 13-290-008-01-US Rev 05
Impulse Dynamics (USA), Inc50 Lake Center Executive ParkwaySuite 100, 401 Route 73 N, Bldg. 50Marlton, NJ 08053U.S.A.OPTIMIZER is a US registered trademark of Impulse Dynamics.OMNI is a trademark of Impulse Dynamics.CCM is a trademark of Impulse Dynamics.The information provided in this document may change without prior notice.This document and its contents are proprietary to Impulse Dynamics. No part of this manual may be reproduced,distributed, or transmitted in any form or by any method, including electronic and mechanical means, without priorwritten express consent from Impulse Dynamics.Please read the complete documentation provided before you use the device.Copyright Impulse Dynamics 2018 ALL RIGHTS RESERVED.The OPTIMIZER Smart system and the CCM technology are protected by several U.S. Patents. For an up-todate list of relevant patents and patent applications, visit our patents page: http://www.impulsedynamics.com/us/patents.
TABLE OF CONTENTSEXPLANATION OF SYMBOLS ON LABELS . V1.THE OPTIMIZER SMART SYSTEM: AN OVERVIEW. 71.1Description of the OPTIMIZER Smart IPG . 71.2OPTIMIZER Smart IPG Lead Connectors . 91.3OPTIMIZER Smart IPG Physical Characteristics . 91.4OPTIMIZER Smart IPG Battery . 111.5OPTIMIZER Smart IPG Rechargeable Battery Behavior . 111.6User Profile and Training . 122.INDICATIONS . 123.CONTRAINDICATIONS AND PRECAUTIONS . 124.WARNINGS . 124.1Potential Complications of Device Implantation . 124.1.1 Atrial and Ventricular Arrhythmias Potentially Caused by Lead Implantation . 134.1.2 Ventricular Arrhythmias Potentially Caused by CCM Signals . 134.1.3 Atrial Arrhythmias Potentially Caused by CCM Signals . 145.4.2Experience and Training. 144.3Handling . 144.4Storage and Handling . 154.5Packaging Information . 154.6Resterilization and Reuse . 154.7Cremation . 15CAUTIONS . 155.1Environmental Conditions . 155.2Electrocautery. 165.3RF Ablation . 165.4Diathermy (Medical “Short Wave” Induction Heating) . 175.5Defibrillation and Cardioversion . 175.6Radiation Therapy . 175.7Nuclear Magnetic Resonance (NMR), Magnetic Resonance Imaging (MRI) . 185.8Lithotripsy . 185.9Therapeutic Ultrasound . 185.10 Transcutaneous Electrical Nerve Stimulation (TENS) . 195.11 Home Appliances . 195.12 Store Anti-Theft Systems/Airport Security Screening Systems . 195.13 Industrial Machinery . 19i
5.14 Transmitting Devices .195.15 Cellular and Mobile Phones .206.POTENTIAL ADVERSE EFFECTS . 207.DEVICE IMPLANTATION . 217.1General Considerations .217.2Opening the Lead Sterile Package(s) .217.3Opening the OPTIMIZER Smart Sterile Package .227.4Verifying Lead Placement .227.5Connecting the Implanted Leads to the OPTIMIZER Smart IPG .227.6Dissection of the IPG Pocket .237.7Inserting the OPTIMIZER Smart IPG and Closing the Pocket .238.DEVICE EXPLANTATION / REPLACEMENT . 249.OPTIMIZER SMART IPG: FUNCTIONS AND PROGRAMMING OPTIONS . 259.1Operating Modes .259.2CCM Off Status .259.3A/V Sensing .269.3.1 A/V Sensing Leads .269.3.2 A/V Sensing Parameters .269.3.3 Refractory Period .269.4CCM Delivery Options .279.5CCM Signal Delivery .279.5.1 Channels .279.5.2 CCM Signal Parameters .279.5.3 Balancing Phase .289.5.4 Parameter Interaction .289.6CCM Inhibit Parameters .299.6.1 Number of Beats for CCM Inhibition .299.6.2 Conditions Causing Inhibition in Active OVO-LS-CCM Mode .299.7Local Sensing.319.8CCM Triggering Based on Local-Sense Events .319.8.1 Local Sense Alert Window.319.8.2 Local Sense Refractory Periods in Active OVO-LS-CCM Mode .329.8.3 Remarks.329.8.4 Parameter Interaction .3310.SERVICE AND WARRANTY. 3310.1 Limited Warranty Information.3310.2 Mandatory Battery Charging .33ii
APPENDIX I . 35Physical Characteristics . 35Battery35Current Consumption . 36Safe Mode36Programmable Parameters . 36Factory Settings . 38Emergency Programming . 39APPENDIX II . 41Communications/Telemetry . 41APPENDIX III . 41Testing procedure for device/device interaction:. 41APPENDIX IV . 42Extrapolated Battery Life of the OPTIMIZER SMART IPG . 42Extrapolated Battery Charge Longevity . 42APPENDIX V . 44Scientific Background About Heart Failure and Cardiac Contractility Modulation. 44APPENDIX VI . 46A. Current Clinical Summary: FIX-HF-5C . 461.0 Study Design . 462.0 Demographics and Baseline Characteristics . 473.0 Effectiveness Results . 484.0 Safety Results . 51B. Current Clinical Summary: FIX-HF-5C2 . 521.0 Overview of Study Design . 522.0 Overview of Methodology. 533.0 Results . 534.0 Discussion . 725.0 Risk-Benefit. 726.0 Conclusions . 73iii
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EXPLANATION OF SYMBOLS ON LABELSSYMBOLDESCRIPTIONManufacturerDate of ManufactureConsult instructions for use.Caution, consultaccompanying withEthyleneUse ByDo Not ReusePart NumberLot NumberSerial NumberOpen HereTorque WrenchPort PlugDo Not Use if Package isDamagedMR - Conditionalv
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1.THE OPTIMIZER SMART SYSTEM: AN OVERVIEWThe OPTIMIZER Smart system is intended for the treatment of moderate to severe heart failure,as defined in the Indication for Use (Section 2).” The system comprises the followingcomponents: Programmable OPTIMIZER Smart Implantable Pulse Generator (IPG), Model CCMX10; port plug, #2 torque wrench for securing the implanted leads OMNI Smart Programmer, model OMNI II (with OMNI Smart Software) OPTIMIZER Smart Charger, model Mini Charger Implantable leads: 2 ventricular leads.1.1Description of the OPTIMIZER Smart IPGThe OPTIMIZER Smart Implantable Pulse Generator (IPG) is a programmable devicewith an internal battery and telemetry functions. The system is intended to treat heartfailure, a condition wherein the heart muscle does not pump blood as well as it should,resulting in reduced cardiac output. The OPTIMIZER Smart IPG monitors the heart’sintrinsic activity and delivers CCM signals to cardiac tissue during the ventricularabsolute refractory period, when the cardiac tissue is not capable of activation, thusrendering the CCM signal as non-excitatory. CCM signal delivery is synchronizedwith the detected local electrical activity and is capable of achieving the desired effect onthe tissue, i.e. treating heart failure by increasing the cardiac output, or increasing thecontractility of cardiac muscle.The above-mentioned programmability of the OPTIMIZER Smart IPG implies thatmedical personnel can tailor the operating parameters to each patient’s individualrequirements with the OMNI Smart Programmer. The OPTIMIZER Smart IPG ispowered by a rechargeable battery (see Section 1.4), which can be rechargedtranscutaneously by inductive power transfer with the OPTIMIZER Mini Charger.The OPTIMIZER Smart IPG and the OMNI Smart Programmer communicate viatelemetry (for details, see Appendix III). Telemetry is used for IPG programming as wellas for obtaining diagnostic data by device interrogation. The programmer records devicedata, maintains a system log, stores standard programs for later use, provides an option toprogram “safe” parameters in an emergency, etc.The OPTIMIZER Smart IPG is connected to two (2) leads that are implanted in the rightventricle. The OPTIMIZER Smart IPG is compatible with standard pacemaker leadsequipped with IS-1 connectors.7
The implanting physician can select any standard ventricular pacing leads with thefollowing characteristics: Bipolar lead approved for transvenous intracardiac ventricular pacing. Standard IS-1 bipolar connector. Maximum lead diameter 8 French Active fixation with electrically-active corkscrew distal electrode with a minimalelectrically-active surface area of 3.6 mm2. Distal (Tip) electrode coated with low-polarization coating (e.g. titanium nitrideor iridium oxide). Proximal (Ring) electrode electrically-active surface of at least 3.6 mm2, and TipRing spacing between 8 and 30 mm Maximum total wire resistance of 200 ΩNote: The leads qualified for delivering CCM signals from OPTIMIZER IPGs must becommercial models that are FDA approved.Pacing Leads Suitable for use with the OPTIMIZER IPG for CCM Signal DeliveryCurrent Offerings as of January 2, 2019Requirementfor CCMPacing Leads Suitable for use with OPTIMIZER IPGMedtronicCapSureFixNovusMRI SureScan 4076, 5076,5086 LeadsMedtronicSelectSecure MRISureScan 3830 LeadAbbott(StJude)2088TCTendrilSTSleadAbbott (StJude)LPA1200MTendrilMRI LeadBostonScientificIngevity7740,7741,7742 andBiotronikSolia-SLeadsIngevity 7840,7841,7842LeadsBipolar leadapproved ESYESYESYESStandard IS-1bipolarconnectorYESYESYESYESYESYESYES, 4.2mm2YES, 3.6 mm2YES,6.9 mm2YES, 6.0mm2YES, 4.5mm2YES, 4.5mm2Active fixationwithelectricallyactive corkscrewdistal electrode8
Requirementfor CCMPacing L
Feb 13, 2021 · 50 Lake Center Executive Parkway Suite 100, 401 Route 73 N, Bldg. 50 Marlton, NJ 08053 . U.S.A. OPTIMIZER . OMNI
