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6.22

Instructions for Use & Clinical Reference Manual (US)

In addition, data was obtained to evaluate the device safety with respect to its placement
across the aortic valve. A total of 50 echocardiograms available on 14 subjects were analyzed
by an independent CoreLab research group. The analysis showed that there was no evidence of
structural damage to the heart during use or in any subsequent follow up. These results were
also submitted to FDA in the 510(k) submission for the Impella 5.0 and Impella LD (K08331),
which was cleared in 2009.

Overall, the RECOVER I study demonstrated that the Impella 5.0 and Impella LD could be used in
the selected patient group, resulting in:

•

A high survival rate of treated patients

•

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 morbidities.

DEVICE FAILURES AND REPLACEMENTS

There were no device failures or replacements reported during the study.

FINANCIAL DISCLOSURE

The Financial Disclosure by Clinical 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 of, any clinical investigator conducting clinical studies
covered by the regulation. This clinical study included 7 investigators. Neither of the clinical
investigators had disclosable financial interests/arrangements as defined in sections 54.2(a), (b),
(c), and (f). The information provided does not raise any questions about the reliability of the
data.

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Содержание Impella 2.5

Страница 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...

Страница 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...

Страница 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...

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Страница 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...

Страница 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...

Страница 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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Страница 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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Страница 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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Страница 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...

Страница 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...

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

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Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 22: ......

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 38: ......

Страница 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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Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 108: ......

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 171: ......

Страница 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...

Страница 173: ......

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 181: ......

Страница 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...

Страница 183: ......

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 201: ......

Страница 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...

Страница 203: ......

Страница 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...

Страница 205: ......

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 210: ...INDEX TBD...

Страница 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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