Abiomed Impella 2.5 Instructions For Use Manual Download Page 11

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1 INDICATIONS, CONTRAINDICATIONS,

AND POTENTIAL ADVERSE EVENTS

INDICATIONS (UNITED STATES) ...................................................................1.1

Impella

2.5, Impella CP

, Impella

5.0, and Impella

LD ................................ 1.1

CONTRAINDICATIONS (UNITED STATES)......................................................1.1

POTENTIAL ADVERSE EVENTS (UNITED STATES) .........................................1.2

Summary of Contents for Impella 2.5

Page 1: ...Impella 2 5 5 0 LD and Impella CP INSTRUCTIONS FOR USE CLINICAL REFERENCE MANUAL United States only ImpellaVentricular SupportSystems for Use During Cardiogenic Shock...

Page 2: ...a Systems using the Automated Impella Controller Information contained in this document is subject to change without notice 2015 Abiomed Inc All rights reserved The ABIOMED logo and ABIOMED are regist...

Page 3: ...chen Germany 49 241 8860 0 voice 49 241 8860 111 fax europe abiomed com email www abiomed com 24 Hour Clinical Support Center N America 1 800 422 8666 Europe 49 0 1805 2246633 March 2016 Document No x...

Page 4: ......

Page 5: ...ment Overview 7 1 General Patient Care Considerations 7 1 Transport Within the Hospital 7 2 Right Heart Failure 7 2 ECG Interference 7 3 Latex 7 3 Use of Echocardiography for Positioning of the Impell...

Page 6: ...g the Diagnostic Catheter 5 18 Figure 5 22 Loading the Catheter on the Guidewire using the EasyGuide Lumen 5 18 Figure 5 23 Loading the Catheter on the Guidewire without the EasyGuide Lumen and Aligni...

Page 7: ...ynamics from Baseline to 48 Hours Post Device Implant for RECOVER I Patients 6 15 Figure 6 14 Decrease in Inotropes and Pressors Post Device Placement for RECOVER I Patients 6 15 Figure 6 15 RECOVER I...

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Page 9: ...s an overview of the system and describes its major components and features Section 4 Using the Automated Impella Controller describes the controls and various screen types on the Automated Impella Co...

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Page 11: ...S CONTRAINDICATIONS AND POTENTIAL ADVERSE EVENTS INDICATIONS UNITED STATES 1 1 Impella 2 5 Impella CP Impella 5 0 and Impella LD 1 1 CONTRAINDICATIONS UNITED STATES 1 1 POTENTIAL ADVERSE EVENTS UNITED...

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Page 13: ...dual myocardial function Optimal medical management and conventional treatment measures include volume loading and use of pressors and inotropes with or without IABP CONTRAINDICATIONS UNITED STATES Pa...

Page 14: ...accident Stroke Death Device malfunction Failure to achieve angiographic success Hemolysis Hepatic failure Insertion site infection Limb ischemia Myocardial infarction Need for cardiac thoracic or ab...

Page 15: ...2 WARNINGS AND CAUTIONS WARNINGS 2 1 CAUTIONS 2 3...

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Page 17: ...osable device and is intended for single use only Reuse reprocessing or resterilization may compromise the structural integrity of the catheter and or lead to catheter failure which in turn may result...

Page 18: ...omated Impella Controller to display soft button menu selections that were not selected by the user Operators should be aware that under these conditions the operating parameters are not affected No u...

Page 19: ...xercise special care when inserting the Impella Catheter in patients with known or suspected unrepaired abdominal aortic aneurysm or significant descending thoracic aortic aneurysm or dissection of th...

Page 20: ...the bed mount as a handle Do NOT alter the Impella Introducer kit in any way Aspiration and saline flushing of the Impella Introducer kit sheath dilator and valve should be performed to help minimize...

Page 21: ...omponents 3 2 Impella Set up and Insertion kits Impella 2 5 and Impella CP 3 2 Impella Axillary Insertion kit Impella 2 5 5 0 and Impella CP 3 2 System Configurations 3 3 IMPELLA CATHETER 3 5 Differen...

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Page 23: ...la Catheter in the Heart When properly positioned the Impella Catheter delivers blood from the inlet area which sits inside the left ventricle through the cannula to the outlet opening in the ascendin...

Page 24: ...er 0 018 inch 260 cm placement guidewire Connector cable Purge cassette Introducer kit Peel away introducer 13 Fr for Impella 2 5 14 Fr for Impella CP Dilator s 13 Fr for Impella 2 5 8 Fr 10 Fr 12 Fr...

Page 25: ...ntroller Impella 2 5 or Impella CP Catheter and Accessories Impella CP shown Standard configuration for Impella 2 5 and Impella CP Figure 3 2b illustrates the standard configuration of the Impella 2 5...

Page 26: ...y components in the initial set up configuration Impella 5 0 Catheter Dextrose Solution Automated Impella Controller Purge Cassette D20 Disconnect Y Connector from Purge Tubing Disconnect Y Connector...

Page 27: ...utlet Area Open Pressure Area Red Impella Plug Clear Sidearm Red Pressure Sidearm Repositioning Unit Catheter Shaft Infusion Filter Pressure Reservoir Check Valve Impella 2 5 Pigtail EasyGuide Lumen C...

Page 28: ...Sidearm Check Valve Pigtail Cannula Inlet Area Motor Housing Differential Pressure Sensor Outlet Area Impella 5 0 Red Impella Plug Catheter Shaft Infusion Filter Pressure Reservoir Clear Sidearm Check...

Page 29: ...peration Outlet area The proximal end of the cannula is attached to the outlet area where the blood exits the cannula EasyGuide lumen The red loading lumen on the Impella 2 5 and Impella CP runs from...

Page 30: ...proximal to the motor The placement signal lumen Impella 2 5 and Impella CP Catheters that allows for pressure and waveform displays The Impella 2 5 and Impella CP Catheters have two sidearms a red pr...

Page 31: ...the electrical properties of the membrane change when it flexes This allows the sensor to generate an electrical signal proportional to how much the membrane is flexed and thus proportional to the dif...

Page 32: ...sensor membrane is the same resulting in a flat placement signal see Figure 3 8 Impella Flow 5 0 System Power MUTE ALARM 0 0 DISPLAY 0 0 MENU PURGE SYSTEM Impella 5 0 S N 123456 30 06 2011 05 30 100...

Page 33: ...m is operated away from AC power The controller weighs 26 lbs 11 8 kg and can operate on its internal battery for at least 60 minutes when fully charged Automated Impella Controller operation is descr...

Page 34: ...e cassette and related components Table 3 4 describes each component Purge Fluid Spike Purge Tubing Supply Line Purge Pressure Transmitter Purge Cassette Y Connector Yellow Luer Connector Figure 3 10...

Page 35: ...y the purge pressure algorithm to maintain the purge pressure Purge tubing Carries purge fluid from the purge cassette to the Impella Catheter Yellow luer connector Connects the purge tubing to the Y...

Page 36: ...ins Peel away introducer with hemostatic valve for tight fit around components and single step break away configuration Dilator easy to insert and remove with soft design for atraumatic approach into...

Page 37: ...with a 10 mm diameter x 20 cm length Hemashield Platinum graft Figure 3 16 Placement Guidewire The 0 018 inch 260 cm placement guidewire is used for the placement of the Impella 2 5 5 0 or Impella CP...

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Page 39: ...W 4 1 AUTOMATED IMPELLA CONTROLLER FEATURES 4 2 HOME SCREEN 4 6 PLACEMENT SCREEN 4 9 Placement Signal Waveform 4 9 Motor Current Waveform 4 10 PURGE SCREEN 4 10 Purge Flow 4 11 Purge Pressure 4 11 INF...

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Page 41: ...onitors the catheter for alarms and provides real time catheter position information regarding the location of the catheter across the aortic valve The controller can be powered by AC power or can ope...

Page 42: ...e sure you turn this switch on If the battery switch is not turned on the Automated Impella Controller will not be able to operate on battery power Figure 4 1 illustrates the features on the front of...

Page 43: ...plugged into AC power Selector knob Rotating push button turn clockwise and counterclockwise to navigate through menu items push to make a selection Purge pressure transmitter A flexible diaphragm on...

Page 44: ...left and right sides of the Automated Impella Controller These features are described in Table 4 2 Figure 4 2 Automated Impella Controller Features Side Views Purge Cassette Door Release Bed Mount Pow...

Page 45: ...safety device in the event of current overload AC plug Connection point on the controller for the AC power cord Power switch Button that turns the controller on or off ON Press and hold the power swi...

Page 46: ...Display Area Purge System Area Flow Area System Power Area Purge System Purge Pressure 600 mmHg Purge Flow 20 0 ml hr Figure 4 3 Home Screen Table 4 3 Automated Impella Controller Display Elements Dis...

Page 47: ...uid purge cassette or purge system de airing the purge system or transferring to the standard configuration EXIT Exits the current procedure MENU MENU Brings up a menu of options related to controller...

Page 48: ...message Flow Calculation Disabled Catheter operation icon The circular catheter operation icon rotates when the Impella Catheter is running Central display area On the home screen the central display...

Page 49: ...open pressure area of the catheter with respect to the aortic valve The placement signal is used to verify whether the Impella Catheter is in the aorta or in the ventricle by evaluating the current p...

Page 50: ...ng is 0 1000 mA It is adjustable in 100 mA increments for the Impella Catheter with a minimum difference between upper and lower limits of 200 mA and a maximum difference of 1000 mA To the right of th...

Page 51: ...sure 0 1500 mmHg is displayed to the left of the purge pressure plot The maximum value on this scale can be adjusted from 100 mmHg to 2000 mmHg in increments of 100 mmHg An alarm appears if purge pres...

Page 52: ...usion History Screen MOBILE OPERATION The Li Ion batteries must be charged for 5 hours prior to system operation in order to meet the runtime requirement of 1 hour Failure to do so will yield a shorte...

Page 53: ...iew 5 16 Wireless Insertion Technique 5 16 Recommendations for Handling the Impella 2 5 Catheter 5 16 IMPELLA CP CATHETER INSERTION 5 17 AXILLARY INSERTION OF THE IMPELLA 2 5 5 0 OR IMPELLA CP CATHETE...

Page 54: ...e Pressure 5 49 Purge System Blocked 5 49 PATIENT WEANING 5 49 REMOVING THE IMPELLA 2 5 5 0 OR IMPELLA CP CATHETER 5 50 Removing the Impella with the Introducer in Place 5 50 Removing the Impella Secu...

Page 55: ...y Magnetic resonance angiography MRA Coronary computed tomography angiography CTA Ultrasound Echocardiography LV thrombus Mechanical aortic valve Aortic valve stenosis calci cation Moderate to severe...

Page 56: ...fter the batteries have been fully charged Have a backup Automated Impella Controller purge cassette connector cable and Impella Catheter available in the unlikely event of a device failure SUPPLIES N...

Page 57: ...d Impella Controller for 3 seconds see Figure 5 1 Power Switch on Right Side of Impella Controller Figure 5 1 Automated Impella Controller Power Switch The Automated Impella Controller automatically p...

Page 58: ...Press MENU or plug in new Impella catheter f or case start proced ure 100 Figure 5 2 Automated Impella Controller Startup Screen The startup screen displays The current status of the Impella Catheter...

Page 59: ...leaking for Impella 2 5 and Impella CP Do NOT kink or clamp the Impella Catheter with anything other than a soft jaw vascular clamp Do NOT kink or clamp the peel away introducer CASE START 1 Press the...

Page 60: ...aps into place The controller will automatically begin priming the purge cassette 8 Extend the purge tubing and close the purge cassette door There is sufficient room around the edges of the purge cas...

Page 61: ...lla Catheter off the sterile field 9 Line up the notch on the connector cable with the notch in the blue catheter plug on the front of the Automated Impella Controller and plug the cable into the cont...

Page 62: ...nnect and discard the Y connector with red and yellow luers from the purge tubing Figure 5 8 Connecting the Luer s to the Impella Catheter Impella CP shown 12 When the controller detects that the luer...

Page 63: ...igure 5 10 until the Automated Impella Controller beeps The progress bar shows the progress of the priming White Flush Valve Figure 5 10 Squeezing the White Flush Valve to Prime the Placement Signal L...

Page 64: ...olume Dextrose Concentration Heparin Concentration 500 ml 20 50 units ml OK Figure 5 11 Entering Purge Fluid Information 2 To select the default values displayed on the screen scroll to OK below the t...

Page 65: ...e Purge Tubing to the Connector Cable IMPELLA SYSTEM SET UP CONFIGURATION Figure 5 13 illustrates the correct set up configuration of the Impella System Impella CP shown Impella 5 0 and LD configurati...

Page 66: ...he artery with a 10 Fr dilator prior to inserting the 13 Fr peel away introducer with dilator see Figure 5 14 While inserting the introducer hold the shaft of the introducer to slide it into the arter...

Page 67: ...ends a 6 Fr AL1 or Multipurpose without side holes or 4 5 Fr pigtail with or without side holes over a 0 035 inch diagnostic guidewire into the introducer and advance it into the left ventricle Shapin...

Page 68: ...to coil the guidewire in the left ventricle 10 10 Wet the cannula with sterile water and backload the catheter onto the placement guidewire One or two people can load the catheter on the guidewire Avo...

Page 69: ..._____ 0 0 Min Purge Pressure 600 mmHg Purge Flow 9 0 ml hr Motor Current 0 0 0 mA 10 sec Placement Signal mmHg 109 8 0 93 10 sec 160 0 1000 0 Figure 5 19 Aortic Waveform on Placement Signal Screen Tak...

Page 70: ...lear sidearm ensure that the clear sidearm is clipped to the connector cable and is rotating with the red Impella plug When in the initial set up configuration carefully inspect the catheter for kinki...

Page 71: ...0 Inserting the Peel Away Introducer 4 Administer heparin When the ACT is greater than or equal to 250 seconds remove the dilator Use Fluoroscopy for Placement Impella Catheter performance will be com...

Page 72: ...diagnostic catheter Abiomed recommends a 6 Fr AL1 or Multipurpose without side holes or 4 5 Fr pigtail with or without side holes over a 0 035 inch diagnostic guidewire into the introducer and advance...

Page 73: ...d Damaging Inlet Area During placement of the Impella Catheter take care to avoid damage to the inlet area while holding the catheter and loading the placement guidewire a a Advance the guidewire into...

Page 74: ...Max ________________________ 0 0 Min Purge System Purge Pressure 600 mmHg Purge Flow 9 0 ml hr Motor Current 0 0 0 mA 10 sec Placement Signal mmHg 109 8 0 93 10 sec 160 0 1000 0 Figure 5 25 Aortic Wa...

Page 75: ...ucer must be peeled away and the repositioning sheath inserted into the graft Do NOT resterilize or reuse any components of the Impella Axillary Insertion kit All components are disposable and intende...

Page 76: ...the introducer using heavy sutures or umbilical tape 1 1 Isolate and expose the axillary artery and obtain control via proximal and distal vessel loops Use Fluoroscopy for Placement Impella Catheter p...

Page 77: ...completely sealing over the graft and the 9 Fr catheter open the sidearm flush valve on the introducer and verify blood is not leaking from the system 6 6 Remove the vascular clamp on the graft and in...

Page 78: ...ighten the Tuohy Borst valve to prevent catheter migration 19 Extend the sterile sleeve Attach one end to the repositioning hub and anchor the other to the catheter 1 13 3 To remove the introducer rel...

Page 79: ...NIQUE FOR FEMORAL ARTERY INSERTION 1 Identify the femoral artery and perform a cut down of 3 to 5 cm 2 Expose the femoral artery Wrap vessel loops one distal and one proximal to the subsequent point o...

Page 80: ...he plug 6 6 Hold tension on the proximal vessel loop to prevent bleeding Straighten the blue pigtail and thread it over the 0 018 inch placement guidewire see Figure 5 31 Wet the cannula with sterile...

Page 81: ...t using the standard end to side anastomosis Figure 5 32 Figure 5 32 Femoral Artery Insertion of the Impella 5 0 Catheter Using a Sidearm Graft 10 10 Loosen the proximal vessel loop and advance the ca...

Page 82: ...be manipulated if needed by securing the repositioning sheath and moving the catheter in or out 19 Extend the sterile sleeve Attach one end to the repositioning hub and anchor the other to the cathet...

Page 83: ...ve the valve plane 2 Make an incision or punch no larger than 6 mm at the insertion site on the ascending aorta 3 Attach the Dacron vascular graft 10 mm x 15 cm to the aorta using the standard end to...

Page 84: ...e most proximal portion of the graft 12 While the catheter is being advanced in the aorta the initial placement signal has the characteristics shown in Figure 5 34 The inlet area of the catheter has n...

Page 85: ...N 123456 30 06 2011 05 30 100 CONTROL FLOW P 0 L min 0 0 Max ________________________ 0 0 Min Purge System Purge Pressure 600 mmHg Purge Flow 20 0 ml hr Motor Current 0 0 0 mA 10 sec Placement Signal...

Page 86: ...5 0 0 0 5 O F F Start Pump Purge System Purge Pressure 600 mmHg Purge Flow 9 0 ml hr Motor Current 0 0 0 mA 10 sec Placement Signal mmHg 109 8 0 93 10 sec 160 0 1000 0 Figure 5 36 Starting the Impella...

Page 87: ...stem Power MUTE ALARM 0 0 Impella CP S N 123456 30 06 2011 05 30 100 L min 3 0 Max ________________________ 4 0 Min Purge System Purge Pressure 600 mmHg Purge Flow 10 0 ml hr Placement Signal mmHg 109...

Page 88: ...P 6 1 7 2 1 45 000 P 7 1 8 2 2 47 000 P 8 Recommended maximum P level for continuous use 2 1 2 4 50 000 BOOST Used to confirm stable position after placement can be used to provide maximum flow for up...

Page 89: ...leeding and apply manual pressure above the puncture site 3 Grasp the two wings and bend back until the valve assembly comes apart Continue to peel the two wings until the introducer is completely sep...

Page 90: ...injection ports 3 Clamp the red luer on the Y connector from the red pressure sidearm Disconnect and end cap the red luer 4 Create a slow drip from the NaCl pressure bag to flood the luer connector o...

Page 91: ...Solution in Pressure Bag Connector Cable Figure 5 42 Standard Configuration for Impella System after Transfer from the Set up Configuration Disconnecting the Y Connector When you switch to the standar...

Page 92: ...0 ml hr Motor Current 0 0 0 mA 10 sec Placement Signal mmHg 6 2 2 10 sec 60 20 1000 0 Figure 5 43 Waveform as Catheter is Advanced into the Aorta 2 Gently advance the catheter forward until a pulsatil...

Page 93: ...m Purge Pressure 600 mmHg Purge Flow 20 0 ml hr P 2 P 7 P 8 P 5 P 6 P 9 P 2 P 3 P 0 P 1 P 4 Motor Current 27 0 190 230 mA 10 sec Placement Signal mmHg 35 2 17 10 sec 60 20 1000 0 Figure 5 45 Selecting...

Page 94: ...000 P 5 1 4 3 7 24 000 P 6 1 8 4 0 26 000 P 7 2 6 4 4 28 000 P 8 3 4 4 7 30 000 P 9 4 2 5 3 33 000 Flow rate can vary due to suction or incorrect positioning Vascular Closure When securing the reposi...

Page 95: ...20 1000 0 Figure 5 47 Selecting P Level 4 The catheter operation icon in the lower left corner of the screen begins rotating when the Impella LD Catheter begins to operate 5 Increase P level to P 9 to...

Page 96: ...Motor Current 8 00 690 7 45 mA 10 sec Placement Signal mmHg 35 2 17 10 sec 60 20 1000 0 Figure 5 48 Confirming Placement on the Placement Signal Screen 6 Position the front silicone plug as close as...

Page 97: ...vel that will enable you to achieve the flow rate necessary for patient support You can select one of ten P levels P 0 to P 9 for the Impella LD Catheter see Table 5 6 Suture Depth When securing the s...

Page 98: ...uid Change purge uid Change purge cassette De air purge system Transfer to standard con guration Each procedure can be accessed using the PURGE SYSTEM soft button Transferring to the standard configu...

Page 99: ...w uid bag bottle 4 Select OK to deliver a bolus to the pressure reservoir so that the reservoir can maintain purge pressure during the change A progress bar shows the progress of the bolus After the b...

Page 100: ...o deliver a bolus to the pressure reservoir so that the reservoir can maintain purge pressure during the change A progress bar shows the progress of the bolus After the bolus is delivered the controll...

Page 101: ...door when you close the door 6 The system automatically primes the purge cassette A progress bar shows the progress of the priming Once the priming is complete you are prompted to connect the purge ca...

Page 102: ...Catheter by opening the FLOW CONTROL meter and reducing the P level to P 0 d Disconnect the catheter from the Automated Impella Controller e Remove the Impella Catheter with the use of fluoroscopic i...

Page 103: ...ems have been approved for 6 days of use However weaning could be delayed beyond the normal use for temporary support as an unintended consequence of continued instability of the patient s hemodynamic...

Page 104: ...ler for 3 seconds 6 Apply manual compression for 40 minutes or per hospital protocol REMOVING THE IMPELLA SECURED WITH THE REPOSITIONING SHEATH 1 When ACT is below 150 seconds press FLOW CONTROL and r...

Page 105: ...otate the hub sheath to better position the outlet of the wire at the distal tip of the sheath Figure 5 52 Inserting the Guidewire with the Cheater 4 Advance the guidewire tip into the descending aort...

Page 106: ...a LD Catheter across the aortic valve reduce the P level to P 1 2 Carefully pull the Impella LD Catheter back through the aortic valve and into the ascending aorta Depending on the level of the insert...

Page 107: ...7 Real World Impella Registry Results For all Impella Devices 6 7 Additional Analysis of the Impella Registry Data 6 10 Benchmarking Impella vs Approved VAD in AMICS 6 12 Hemodynamic Effectiveness Res...

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Page 109: ...LINICAL INCLUSION AND EXCLUSION CRITERIA Eligible patients were those who presented with cardiogenic shock within 48 hours of an acute myocardial infarction or suspicion of an acute coronary syndrome...

Page 110: ...rt device Secondary Endpoints Hemodynamic change during the course of treatment which is defined as the change in measured values from the baseline pre implantation after 24 and 48 hours using a gener...

Page 111: ...number 38 10 54 7 23 3 0 370 Anterior myocardial infarction number 50 13 54 7 46 6 1 000 Time from AMI to support device implant in hours mean SD 9 9 6 4 9 4 6 6 10 4 6 5 0 696 Table 6 2 Baseline hemo...

Page 112: ...gure 6 1 Kaplan Meier survival curves survival to 30 days for the ISAR SHOCK trial In addition Adverse Events AEs were monitored for the trial for 30 days post implant as secondary endpoint There were...

Page 113: ...ignificant improvement of cardiac index in the Impella 2 5 arm compared to the IABP arm post device insertion as shown in Figure 6 3 In addition after 24 hours of support fewer patients supported with...

Page 114: ...inical Investigators regulation 21 CFR 54 requires applicants who submit a marketing application to include certain information concerning the compensation to and financial interests and arrangement o...

Page 115: ...by qualifying sites in the U S and Canada Since the registry was started to date a total 59 sites have participated As of June 30 2015 there were 40 open sites The sites include high and low volume ce...

Page 116: ...a support cardiovascular medication laboratory results patient s outcome information at discharge and 30 day follow up as well as site reported adverse events Both site reported safety data and CEC ad...

Page 117: ...y bridge to bridge In aggregate 45 7 were discharged 85 8 with recovery 12 8 transferred to another hospital on Impella support for care management and potential heart transplant or bridge to transpla...

Page 118: ...oviding care or severity of the insult that makes the shock irreversible despite effective hemodynamic support The RCT subgroup consisted of 111 patients and the salvage subgroup was made up of the re...

Page 119: ...nts BENCHMARKING IMPELLA VS APPROVED VAD IN AMICS In order to provide a benchmark for the Impella devices in a comparable clinical setting AMICS Abiomed analyzed the results from its real world regist...

Page 120: ...s are provided for each Impella device In addition the survival to discharge results are provided in Figure 6 12 Figure 6 11 Kaplan Meier curve estimates for 30 day survival Figure 6 12 Survival to di...

Page 121: ...G procedure As a result the bleeding rates were similar between the Impella 5 0 LD and AB5000 These were mainly surgical bleeding However the bleeding rates for Impella 2 5 and Impella CP which were p...

Page 122: ...ive forward flow2 3 and systemic aortic pressure AOP contribution 1 2 4 leading to an effective increase in mean arterial pressure MAP and overall cardiac power output CPO 1 5 Combined with LV unloadi...

Page 123: ...ogenic Shock Figure 6 13 Improvement in patient hemodynamics from baseline to 48hrs post device implant for RECOVER I patients Figure 6 14 Decrease in inotropes and pressors post device placement for...

Page 124: ...9 patients in 9 publications treated for this specific proposed indication for use The literature review provides further insight into the use of the Impella devices in routine clinical practice The l...

Page 125: ...cardiac output syndrome post weaning from cardiopulmonary bypass Details of the study design are below CLINICAL INCLUSION AND EXCLUSION CRITERIA Inclusion Criteria 1 Signed Informed Consent 2 Age Eli...

Page 126: ...dition s that could have limited the patient s ability to participate in the study or impact its scientific integrity Patients were assessed at 30 60 180 and 1 year During the assessments clinical dat...

Page 127: ...ent OHT Orthotopic Heart Transplant VAD Ventricular Assist Device STUDY BASELINE PARAMETERS The baseline patient characteristics and hemodynamics are provided below Table 6 5 Baseline patient characte...

Page 128: ...3 84 80 1 55 38 35 NYHA Class I II III IV III or IV 8 33 1 12 16 67 2 12 25 00 3 12 50 00 6 12 75 00 9 12 0 21 38 48 2 09 48 41 5 49 57 19 21 09 78 91 42 81 94 51 Prior Cardiac Procedures Thrombolytic...

Page 129: ...r survival curve for freedom from death to 1 year There were no Unanticipated Adverse Device Effects UADEs over the duration of the RECOVER I trial There were two 2 serious adverse events SAEs each ef...

Page 130: ...ients A consistent and reproducible hemodynamic support A rapid wean of patients off of inotropes and pressors An excellent device safety profile with a low rate of SAEs and other device related morbi...

Page 131: ...low volume centers academic teaching and non academic hospitals public and private institutions as well as for profit and not for profit centers almost entirely from the United States thus providing a...

Page 132: ...verall outcome results appear favorable for this sick patient group particularly when compared to the historical results for similar patients see the benchmark and literature review sections below Fig...

Page 133: ...s used for each classification analysis For Classification A the overall results Kaplan Meier curve estimates for survival to 30 days for the patients are shown in Figure 6 21 Figures 6 22 and 6 23 gi...

Page 134: ...r Classification B the overall results Kaplan Meier curve estimates for survival to 30 days for the patients are shown in Figure 6 24 Figures 6 25 and 6 26 give the results for the different devices u...

Page 135: ...with a broad spectrum of pre existing co morbidities and risk factors The overall outcomes are favorable Despite the limited sample size the data suggests that Impella 5 0 and Impella LD patients do...

Page 136: ...nts that presented either with PCCS CS or PCCS FW The LCOS patients were excluded so the analysis is conservative considering the invasiveness of the AB5000 it is very unlikely that the device was use...

Page 137: ...Transient Ischemic Attack In addition the rates of site reported in hospital adverse events which were captured in both registry CRFs were compared The results of this comparison are provided in Table...

Page 138: ...y and demand This cascade of hemodynamic effects has been described in the literature21 733 and validated in computational modeling and a variety of pre clinical and clinical studies 1 7 For the RECOV...

Page 139: ...for the proposed indications for use The literature review provides further insight into the use of the Impella devices in routine clinical practice The literature analysis shows that post surgical p...

Page 140: ...G AND MANAGING IMPELLA CATHETER POSITION ALARMS 7 10 Correct Position 7 11 Impella 2 5 or Impella CP Catheter Fully in Ventricle 7 12 Impella 2 5 or Impella CP Catheter Completely in the Aorta or Inle...

Page 141: ...ailure and Effects on Position Control 7 23 Suction Detection During Sensor Drift or Sensor Failure 7 24 ENABLING PURGE FLOW NOTIFICATIONS 7 24 DISABLING AUDIO FOR PLACEMENT SIGNAL LUMEN BLOCKED ALARM...

Page 142: ...one in accordance with hospital protocol using aseptic technique Assess access site for bleeding and hematoma Monitor pedal pulses To prevent the purge tubing from kinking do not allow the red Impella...

Page 143: ...C power once you arrive at your destination When rolling the Automated Impella Controller cart across a threshold firmly grasp the cart handle and pull it over the threshold Pay close attention to all...

Page 144: ...lative to the aortic valve and other intraventricular structures post placement The best echocardiographic views for positioning the Impella Catheter in the left ventricle are a long axis transesophag...

Page 145: ...er outlet area Impella Catheter inlet area Location of mitral chordae RV LA Papillary muscle Transthoracic Echocardiogram TTE of Impella Catheter LV Papillary muscle Mitral valve LA Septum Impella Cat...

Page 146: ...hy will likely show the following as depicted in Figures 7 2a TEE and 7 3a TTE Catheter inlet area 3 5 cm below the aortic valve Catheter outlet area well above the aortic valve frequently not visible...

Page 147: ...on and negatively impact catheter flow If the inlet area of the catheter is lodged adjacent to the papillary muscle the inflow may be obstructed resulting in suction alarms This positioning is also li...

Page 148: ...an 4 cm below the aortic valve Catheter outlet area across or near the aortic valve c Impella Catheter Inlet in Aorta TEE Catheter inlet area in aorta or near the aortic valve Catheter pigtail too clo...

Page 149: ...e than 4 cm below the aortic valve Catheter outlet area across or near the aortic valve Aorta Papillary muscle c Impella Catheter Inlet in Aorta TTE Catheter inlet area in aorta or near the aortic val...

Page 150: ...ever the echocardiogram reveals a dense mosaic pattern of turbulence beneath the aortic valve bottom image in Figure 7 4 this likely indicates that the outlet area of the catheter is in the wrong posi...

Page 151: ...in the groin area UNDERSTANDING AND MANAGING IMPELLA CATHETER POSITION ALARMS The Automated Impella Controller continuously monitors the catheter based on the placement signal and the motor current P...

Page 152: ...ONTROL FLOW A U T O L min 4 0 Max ________________________ 3 0 Min Purge System Purge Pressure 600 mmHg Purge Flow 9 0 ml hr Motor Current 8 08 68 4 7 37 mA 10 sec Placement Signal mmHg 109 8 0 93 10...

Page 153: ...10 sec 160 0 1000 0 8 08 7 8 3 7 93 1 R ed uce t h e P lev el t o P 2 un t i l i m a g i n g i s a v a i la b le 2 R ep osi t i on w i t h i m a g i n g 3 R et ur n t o p r ef er r ed P lev el a n d c...

Page 154: ...00 CONTROL FLOW A U T O L min 4 0 Max ________________________ 3 0 Min Purge System Purge Pressure 600 mmHg Purge Flow 10 0 ml hr Motor Current 8 08 7 8 3 7 93 mA 10 sec Placement Signal mmHg 92 64 7...

Page 155: ...9 2012 05 30 100 CONTROL FLOW A U T O L min 4 0 Max ________________________ 3 0 Min 1 C on f i r m I m p ella p osi t i on w i t h i m a g i n g 2 P ull I m p ella b a ck 2 cm I m p ella P osi t i on...

Page 156: ...0 mA 10 sec Placement Signal mmHg 6 2 2 10 sec 60 20 1000 0 5 0 Impella Position Wrong 1 R ed uce t h e P lev el t o P 2 un t i l i m a g i n g i s a v a i la b le 2 R ep osi t i on w i t h i m a g i...

Page 157: ...he home screen Impella Position Unknown In this situation the screen will appear as shown in Figure 7 11 Notice that the flow rate is displayed in yellow in the lower left corner of the screen indicat...

Page 158: ...2 Max ________________________ 4 8 Min Purge System Purge Pressure 600 mmHg Purge Flow 20 0 ml hr Motor Current 8 00 690 7 45 mA 10 sec Placement Signal mmHg 3 31 14 10 sec 1 C on f i r m I m p ella p...

Page 159: ...re SUCTION WITH THE IMPELLA 2 5 OR IMPELLA CP CATHETER If the Automated Impella Controller detects suction while running in AUTO mode it automatically reduces motor speed to lower the flow rate to res...

Page 160: ...ay from the interior ventricular wall 3 Assess patient s fluid intake and output to confirm adequate volume status 4 Confirm right ventricular function by assessing CVP or right side function with ech...

Page 161: ...If repositioning will be delayed reduce the P level if tolerated by patient hemodynamics Return to the previous P level after repositioning Reassess position after flow rate has returned to desired t...

Page 162: ...ired and physicians should consider systemic delivery of an alternative anticoagulant DO NOT add any alternative anticoagulant such as a direct thrombin inhibitor to the purge fluid The Impella Cathet...

Page 163: ...t the tubing 5 Flood the open port of the red pressure sidearm and then reconnect 6 Squeeze the white wings of the flow valve for 15 to 20 seconds to flush the pressure lumen to remove all blood from...

Page 164: ...and Placement Monitoring Suspended To silence this alarm go to MENU and select SETTINGS SERVICE SENSOR FAILURE AND EFFECTS ON POSITION CONTROL If the pressure sensor fails placement monitoring is swit...

Page 165: ...he catheter as described in Table 7 1 If hemodynamic parameters such as low aortic pressure or high pulmonary artery pressure indicate suction caused by inadequate filling volume reduce P level and fo...

Page 166: ...0 0 Max ________________________ 0 0 Min Purge System Purge Pressure 600 mmHg Purge Flow 10 0 ml hr Impella CP S N 123456 30 09 2012 05 30 Motor Current 0 0 0 mA 10 sec Placement Signal mmHg 109 8 0 9...

Page 167: ...he ascending aorta Electromagnetic interference may appear as Instability in the displayed location of the mapping catheter Magnetic interference errors generated by the electroanatomic mapping system...

Page 168: ...eration When the MNS magnets are in the Navigate position the displayed Impella Catheter flow may be artificially elevated To accurately assess the flow rate note the displayed flow when the magnets a...

Page 169: ...appear on the screen asking you to confirm re starting the Impella Catheter at the previously set P level 8 Press OK within 10 seconds to confirm restarting the Impella Catheter at the previously set...

Page 170: ...ller software stops responding follow the procedure below to restart the controller without stopping the Impella Catheter 1 Press and hold the power switch for 30 seconds 2 An Emergency Shutdown Immin...

Page 171: ......

Page 172: ...ALARMS OVERVIEW 8 1 Alarm Levels 8 1 Alarm Display 8 2 Mute Alarm Function 8 2 Alarm History Screen 8 2 ALARM MESSAGE SUMMARY 8 3 8 AUTOMATED IMPELLA CONTROLLER ALARMS...

Page 173: ......

Page 174: ...played if it is a higher priority alarm than the one that was muted ALARM LEVELS Alarms are divided into three levels of severity Advisory white Serious yellow Critical red Table 8 1 Alarm Levels Cate...

Page 175: ...t o p r ef er r ed P lev el a n d con f i r m p osi t i on i n g w i t h i m a g i n g Alarm Window Mute Alarm Indicator Figure 8 1 Alarm Window MUTE ALARM FUNCTION Pressing the MUTE ALARM button on...

Page 176: ...lure Plug controller into AC power One of the batteries has failed Battery Temperature High Switch to backup controller Battery temperature is greater than 60 C Complete Procedure 1 Follow the steps o...

Page 177: ...ttempt There may be a mechanical or electrical problem in the Impella Catheter Impella Stopped 1 Replace white connector cable 2 Switch to backup controller 3 Replace Impella Catheter There is a probl...

Page 178: ...ower Battery has 50 remaining capacity Battery Temperature High 1 Check controller for blocked air vents 2 Switch to backup controller Battery temperature is greater than 50 C and less than or equal t...

Page 179: ...id bag Suction 1 Check filling and volume status 2 Check Impella position 3 Reduce P level Suction is detected Advisory Alarms AC Power Disconnected Controller is running on battery power AC power was...

Page 180: ...mL hr Purge Flow Increased The purge flow has increased by 2 5 mL hr or more This is a notification only no action is required Purge flow has increased by 2 5 mL hr Purge Volume Low 1 Open PURGE SYSTE...

Page 181: ......

Page 182: ...COMPATIBILITY 9 6 TRANSPORT BETWEEN HOSPITALS 9 7 Guidelines for Patient Transport 9 7 Important Transport Considerations 9 8 FAA Advisory 9 8 VGA MONITOR CONNECTION 9 11 ALARM DELAY INFORMATION 9 12...

Page 183: ......

Page 184: ...r consisting of the motor motor housing cannula with inlet and outlet and pigtail at the tip Purge pressure Pressure present in the Impella Catheter and in the infusion line Purge system Impella purge...

Page 185: ...6 Non Sterile The product is not sterile 2016 06 01 Use by date eg use before June 1 2016 Do not reuse Sterilized using ethylene oxide Electric scrap must be disposed of separately Must not be dispose...

Page 186: ...ckaged Maximum 13 6 kg 30 lbs Maintenance and repair interval 12 months Work must be performed by technicians authorized by Abiomed who have completed Abiomed s Service Training Certification Program...

Page 187: ...eral Requirements for Safety Collateral Standard Safety Requirements for Medical Electrical Equipment IEC 60601 1 4 2000 Edition 1 1 Consolidated Edition Medical Electrical Equipment Part 1 4 General...

Page 188: ...troller Class I Equipment Mode of operation Continuous Degree of protection against explosion hazard Not suitable for use in the presence of a flammable anesthetic mixture with air or with oxygen or n...

Page 189: ...ansport the Automated Impella Controller may be exposed to stronger electromagnetic disturbance than during in hospital use Strong electromagnetic disturbance may cause the Automated Impella Controlle...

Page 190: ...be required if a patient requires additional resources and specialized teams located at another hospital The patient may be transferred to such a location using the Automated Impella Controller for h...

Page 191: ...r at the level recommended by the physician responsible for the patient FAA ADVISORY The Automated Impella Controller has been subjected to and passed the EMC EMI tests as specified in IEC 60601 1 2 G...

Page 192: ...an environment Immunity Test IEC 60601 Test Level Compliance Level Electromagnetic Environment Guidance Electrostatic Discharge ESD IEC 61000 4 2 6 kV contact 8 kV air 8 kV contact 15 kV air The rela...

Page 193: ...an electromagnetic site survey a should be less than the compliance level in each frequency range b Interference may occur in the vicinity of equipment marked with the following symbol NOTE 1 At 80 MH...

Page 194: ...e Remote Link is connected to the Recommended Separation Distances Between Portable and Mobile RF Communications Equipment and the Automated Impella Controller Equipment and Systems that are Life Supp...

Page 195: ...omm Failure 40 10 second delay Purge System Blocked 75 45 second delay PATIENT ENVIRONMENT The Automated Impella Controller and the components of the Impella System are approved for use within the pat...

Page 196: ...mm Classification per IEC 60601 1 Protection class I degree of protection CF defibrillation proof Automated Impella Controller and Impella Catheter Protection class I degree of protection CF defibrill...

Page 197: ...Point of insertion 10 cm Repositioning sheath 45 cm Length of sterile sleeve Figure 9 2 Impella 2 5 Catheter Dimensions IMPELLA CP CATHETER DIMENSIONS Figure 9 3 Impella CP Catheter Dimensions 9 2 cm...

Page 198: ...Dimensions IMPELLA LD CATHETER DIMENSIONS Figure 9 5 Impella LD Catheter Dimensions 3 cm 8 cm 11 5 cm 15 5 cm Differential pressure sensor 6 Fr 21 Fr 9 Fr 119 cm min to 127 cm max 9 1 cm Repositioning...

Page 199: ...the runtime requirement of 1 hour Failure to do so will yield a shorter runtime After being unplugged the Automated Impella Controller will operate for at least 60 minutes after the batteries have be...

Page 200: ...OVED GUIDEWIRES AND INTRODUCERS IMPELLA 2 5 AND IMPELLA CP B 1 Abiomed approved Guidewires B 1 Alternative Qualified Introducer Sheaths B 1 APPENDIX C AUTOMATED IMPELLA CONTROLLER MENU STRUCTURE C 1 O...

Page 201: ......

Page 202: ...e responsibility under this warranty will be at its option to 1 repair or replace the Goods or any components of the Goods found to be defective in workmanship or material during the foregoing warrant...

Page 203: ......

Page 204: ...kits were specifically designed for use with the Impella 2 5 and Impella CP Catheters and take into account several technical parameters such as Size of the sheath internal diameter and length Blood l...

Page 205: ......

Page 206: ...in the upper right of the display screen If no alarms are active no bell icon is displayed When you press MUTE ALARM it acknowledges all active alarms and silences the audible alarm indicator for 2 mi...

Page 207: ...discussed in section 4 of this manual shows the volume and amount of heparin and dextrose delivered The top entry in the table shows the volume and amount of heparin and dextrose infused from the top...

Page 208: ...Log Export menu for exporting all logs to a USB stick Disable Enable Placement Monitoring Disable Enable Retrograde Flow Control Disable Enable Audio Placement Signal Not Reliable Allows you to enabl...

Page 209: ...planation for the selected alarm message will be displayed in the failure description box Start Data Snapshot starts the timed data recording function to save real time operating data for later analys...

Page 210: ...INDEX TBD...

Page 211: ...Facsimile 978 777 8411 Email clinical abiomed com Abiomed Europe GmbH Neuenhofer Weg 3 52074 Aachen Germany Voice 49 241 8860 0 Facsimile 49 241 8860 111 Email europe abiomed com Clinical support 24...

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Abiomed Impella 2.5, Instructions For Use Manual

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