Impella 2.5 Instructions for Use and Clinical Reference Manual Rev C Aug 2016

IMPORTANT NOTICE: Read this entire manual before using the Automated Impella® Controller and Impella® 2.5 Circulatory Support System (Impella® 2.5 System). The Impella® 2.5 System is to be used only in accordance with this manual. This manual is only applicable to Impella® systems using the Automated Impella® Controller. Information contained in this document is subject to change without notice. ©2016 Abiomed®, Inc. All rights reserved. The ABIOMED logo and ABIOMED are registered trademarks of Abiomed, Inc. in the U.S.A. and certain foreign countries. Recovering hearts. Saving lives. is a trademark of Abiomed, Inc. Impella is a registered trademark of Abiomed Europe GmbH, a wholly owned subsidiary of Abiomed, Inc., in the U.S.A. and certain foreign countries.

IMPELLA® 2.5 WITH THE AUTOMATED IMPELLA® CONTROLLER INSTRUCTIONS FOR USE & CLINICAL REFERENCE MANUAL (UNITED STATES ONLY)

Rx Only

Abiomed, Inc. 22 Cherry Hill Drive Danvers, MA 01923 978-777-5410 (voice) 978-777-8411 (fax) [email protected] (email) Abiomed Europe GmbH Neuenhofer Weg 3 52074 Aachen, Germany +49 (241) 8860-0 (voice) +49 (241) 8860-111 (fax) [email protected] (email) www.abiomed.com 24-Hour Clinical Support Center: N. America 1-800-422-8666 Europe +49 (0) 1805 2246633 August 2016 Document No. 0042-9011 Rev. C

TABLE OF CONTENTS Introduction... I 1 INDICATIONS, CONTRAINDICATIONS, AND POTENTIAL ADVERSE EVENTS Indications (United States)... 1.1 Contraindications (United States)... 1.1 Potential Adverse Events (United States)... 1.2 2 WARNINGS AND CAUTIONS Warnings... 2.1 Cautions... 2.3 3 THE IMPELLA® CATHETER AND AUTOMATED IMPELLA® CONTROLLER Overview... 3.1 Impella® Catheter... 3.4 Automated Impella® Controller... 3.6 Purge Cassette... 3.7 Accessories... 3.9 4 USING THE AUTOMATED IMPELLA® CONTROLLER Overview... 4.1 Automated Impella® Controller Features... 4.2 Home Screen... 4.6 Placement Screen... 4.9 Purge Screen... 4.10 Infusion History Screen... 4.11 Mobile Operation... 4.12 5 USING THE AUTOMATED IMPELLA® CONTROLLER WITH THE IMPELLA® CATHETER Pre-support Evaluation... 5.1 Startup... 5.2 Case Start... 5.5 Inserting the Impella® Catheter (Wired Insertion)... 5.12 Wireless Insertion of the Impella® 2.5 Catheter... 5.16 Positioning and Starting the Impella® Catheter... 5.17 Modes of Operation... 5.18 Use of the Repositioning Sheath and the Peel-Away Introducer... 5.20 Transfer to Standard Configuration... 5.21 Purge Cassette Procedures... 5.22 Troubleshooting the Purge System... 5.25 Patient Weaning... 5.27 Removing the Impella® Catheter... 5.28 6 CLINICAL EXPERIENCE Clinical Experience Overview... 6.1 PROTECT I Clinical Study ... 6.1 PROTECT II Pivotal Clinical Study Design... 6.2 Accountability of PROTECT II Cohort... 6.6 Limitations of Interpretation of Study Results... 6.7 Study Population Demographics and Baseline Characteristics... 6.7 Procedural Characteristics... 6.9 Safety and Effectiveness Results... 6.12 Secondary Safety Results... 6.19 Secondary Effectiveness Results... 6.21 Summary of Supplemental Clinical Information... 6.22

7 PATIENT MANAGEMENT TOPICS Patient Selection and the Heart Team... 7.1 Patient Management 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 Understanding and Managing Impella®Catheter Position Alarms... 7.3 Impella Stopped... 7.7 Suction... 7.7 Hemolysis... 7.8 Operating the Impella® Catheter without Heparin in the Purge Solution... 7.10 Placement Signal Lumen... 7.10 Enabling Purge Flow Notifications... 7.12 Disabling Audio for Placement Signal Lumen Blocked Alarm... 7.12 Disabling Audio for SUCTION ALARM... 7.12 Disabling Audio for placement signal not reliable alarm... 7.13 Disabling Audio for PURGE PRESSURE HIGH AND PURGE SYSTEM BLOCKED ALARMS... 7.13 Surgical Mode... 7.13 Timed Data Recording... 7.14 Operating the Impella® Catheter in Electromagnetic Fields... 7.14 Transferring from the Automated Impella® Controller to a New Automated Impella® Controller... 7.15 Emergency Shutdown Procedure... 7.16 8 AUTOMATED IMPELLA® CONTROLLER ALARMS Alarms Overview... 8.1 Alarm Message Summary... 8.3 9 GENERAL SYSTEM INFORMATION Terminology, Abbreviations, and Symbols... 9.1 Automated Impella® Controller Mechanical Specifications... 9.3 Automated Impella® Controller Electrical Specifications... 9.3 Equipment Design... 9.4 Equipment Classifications... 9.5 Federal Communications Commission (FCC) Notice... 9.5 Electromagnetic Compatibility... 9.6 Transport Between Hospitals... 9.7 Slave Monitor Connection... 9.11 Alarm Delay Information... 9.12 Patient Environment... 9.12 White Connector Cable... 9.13 Impella® Catheter Parameters... 9.13 Impella® 2.5 Catheter Dimensions... 9.14 Cleaning... 9.15 Storing the Automated Impella® Controller... 9.15 Returning an Impella® Catheter to Abiomed (United States)... 9.15 APPENDICES Appendix A: Impella® System Limited Service Warranty (United States)... A.1 Appendix B: Abiomed-Approved Guidewires and Introducers... B.1 Appendix C: Automated Impella® Controller Menu Structure... C.1 Appendix D: Axillary Insertion Technique... D.1

TABLE OF CONTENTS FIGURES Figure 3.1 Impella® Catheter in the Heart... 3.1 Figure 3.2 Set-up Configuration of the Automated Impella® Controller, Impella® Catheter, and Accessories... 3.3 Figure 3.3 Standard Configuration of the Automated Impella® Controller, Impella® Catheter, and Accessories... 3.3 Figure 3.4 Impella® Catheter... 3.4 Figure 3.5 Automated Impella® Controller – Front View... 3.6 Figure 3.6 Purge Cassette... 3.7 Figure 3.7 White Connector Cable... 3.9 Figure 3.8 Introducer Kit... 3.9 Figure 3.9 0.018 inch, 260 cm Placement Guidewire... 3.9 Figure 3.10 Dextrose Solution... 3.10 Figure 3.11 Automated Impella® Controller Cart... 3.10 Figure 4.1 Automated Impella® Controller Features – Front View... 4.2 Figure 4.2 Automated Impella® Controller Features – Side Views... 4.4 Figure 4.3 Home Screen... 4.6 Figure 4.4 Placement Screen... 4.9 Figure 4.5 Purge Screen... 4.10 Figure 4.6 Infusion History Screen... 4.12 Figure 5.1 Automated Impella® Controller Power Switch... 5.3 Figure 5.2 Automated Impella® Controller Startup Screen... 5.4 Figure 5.3 Initial Case Start Screen... 5.5 Figure 5.4 Inserting Purge Cassette into Automated Impella® Controller... 5.6 Figure 5.5 Inserting the Catheter Plug into the Connector Cable... 5.7 Figure 5.6 Snapping Purge Clip to Connector Cable... 5.7 Figure 5.7 Connecting the Luer(s) to the Impella® Catheter... 5.8 Figure 5.8 Priming the Purge... 5.9 Figure 5.9 Squeezing the White Flush Valve to Prime the Placement Signal Lumen... 5.9 Figure 5.10 Entering Purge Fluid Information... 5.10 Figure 5.11 Changing Purge Fluid Information... 5.11 Figure 5.12 Connecting the Purge Tubing to the Connector Cable... 5.11 Figure 5.13 Set-up Configuration of the Impella® System... 5.11 Figure 5.14 Inserting the Peel-Away Introducer... 5.12 Figure 5.15 Inserting the Diagnostic Catheter... 5.13 Figure 5.16 Loading the Catheter on the Guidewire using the EasyGuide Lumen... 5.13 Figure 5.17 Loading the Catheter on the Guidewire without the EasyGuide Lumen and Aligning the Placement Guidewire... 5.14 Figure 5.18 Inserting the Impella® Catheter... 5.15 Figure 5.19 Aortic Waveform on Placement Signal Screen... 5.15 Figure 5.20 Starting the Impella® 2.5 Catheter... 5.17 Figure 5.21 FLOW CONTROL Options for the Impella® 2.5 Catheter... 5.17 Figure 5.22 Ventricular Waveform on Placement Signal Screen... 5.18 Figure 5.23 Transfer to P-level Mode... 5.18 Figure 5.24 Adjusting P-level... 5.19 Figure 5.25 Removing the Peel-Away Introducer... 5.20 Figure 5.26 Standard Configuration for Impella® System after Transfer from the Set-up Configuration... 5.21 Figure 5.27 Flow Menu after Transfer to Standard Configuration... 5.22 Figure 5.28 Disconnecting the Y Connector from the Purge Cassette Tubing... 5.23

Figure 6.1 PROTECT II Study Schematic... 6.5 Figure 6.2 Study Flow Schematic... 6.6 Figure 6.3a Kaplan-Meier Curves for Major Adverse Events (Intent-to-Treat Population)... 6.14 Figure 6.3b Kaplan-Meier Curves for Major Adverse Events (Per-Protocol Population)... 6.14 Figure 6.4a Additional Analysis of the Composite MAE and MACCE Rates in the Per-Protocol Population Using a Meaningful, Contemporary Definition for Peri-Procedural MI (8x ULN)... 6.23 Figure 6.4b Additional Analysis of the Composite MAE and MACCE Rates in the Intent-to-Treat Population Using a Meaningful, Contemporary Definition for Peri-Procedural MI (8x ULN)... 6.24 Figure 6.5 In-Hospital Mortality for “All USpella HRPCI Patients,” “All USpella HRPCI Patients who met PROTECT II Criteria” and PROTECT II Patients for Both IABP and Impella® 2.5 Arm... 6.25 Figure 7.1 Correct Impella® Catheter Position... 7.4 Figure 7.2 Impella® Catheter Fully in Ventricle... 7.4 Figure 7.3 Impella® Catheter Completely in the Aorta or Inlet and Outlet Areas in Ventricle and Open Pressure Area in Aorta... 7.5 Figure 7.4 Impella® Catheter Position Unknown... 7.6 Figure 7.5 Displacing Air During Flush Solution Change Out Procedure... 7.11 Figure 7.6 Surgical Mode Enabled... 7.13 Figure 8.1 Alarm Window... 8.2 Figure 9.1 Automated Impella® Controller Patient Environment... 9.12 Figure 9.2 Impella® 2.5 Catheter Dimensions... 9.14

TABLE OF CONTENTS TABLES Table 3.1 Table 3.2 Table 3.3 Table 3.4

Impella® Set-up and Insertion Kit Components... 3.2 Impella® Catheter Components... 3.4 Purge Cassette Components... 3.8 Impella® Catheter and Automated Impella® Controller Accessories... 3.9 Table 4.1 Automated Impella® Controller Front View Features... 4.3 Table 4.2 Automated Impella® Controller Side View Features... 4.5 Table 4.3 Automated Impella® Controller Display Elements... 4.6 Table 5.1 Evaluation Prior to Inserting the Impella® Catheter... 5.1 Table 5.2 P-level Flow Rates... 5.19 Table 6.1 Summary of Primary Clinical Studies Reviewed by the FDA (Prior to Approval)... 6.1 Table 6.2 Patient Baseline Characteristics (ITT Population)... 6.8 Table 6.3 Procedural Characteristics... 6.10 Table 6.4a Composite MAE at 30 Days and 90 Days (Intent-to-Treat Population)... 6.13 Table 6.4b Composite MAE at 30 Days and 90 Days (Per-Protocol Population)... 6.13 Table 6.5a Subgroup Without Impella® Roll-In Subject (Intent-to-Treat Population)... 6.15 Table 6.5b Subgroup Without Impella® Roll-In Subject (Per-Protocol Population)... 6.15 Table 6.6a Subgroup Without Rotational Atherectomy (Intent-to-Treat Population)... 6.15 Table 6.6b Subgroup Without Rotational Atherectomy (Per-Protocol Population)... 6.16 Table 6.7a Subgroup With Rotational Atherectomy (Intent-to-Treat Population)... 6.16 Table 6.7b Subgroup With Rotational Atherectomy (Per-Protocol Population)... 6.16 Table 6.8a Subgroup of Unprotected Left Main / Last Patent Conduit (Intent-to-Treat Population)... 6.17 Table 6.8b Subgroup of Unprotected Left Main / Last Patent Conduit (Per-Protocol Population)... 6.17 Table 6.9a Subgroup of Three Vessel Disease (Intent-to-Treat Population)... 6.17 Table 6.9b Subgroup of Three Vessel Disease (Per-Protocol Population)... 6.17 Table 6.10a Subgroup of STS Mortality Score <10 (Intent-to-Treat Population)... 6.18 Table 6.10b Subgroup of STS Mortality Score <10 (Per-Protocol Population)... 6.18 Table 6.11a Subgroup of STS Mortality Score ≥10 (Intent-to-Treat Population)... 6.18 Table 6.11b Subgroup of STS Mortality Score ≥10 (Per-Protocol Population)... 6.19 Table 6.12a Individual MAE Components (ITT Population) Non-Hierarchical... 6.20 Table 6.12b Individual MAE Components (PP Population) Non-Hierarchical... 6.21 Table 6.13a Composite MAE at 30 and 90 Days Using Contemporary Definition for Peri-Procedural MI (8x ULN) (Intent-to-Treat Population and Per-Protocol Population)... 6.22 Table 6.13b Composite MACCE at 30 and 90 Days Using Contemporary Definition for Peri-Procedural MI (8x ULN) (Intent-to-Treat Population and Per-Protocol Population)... 6.23

Table 7.1 Table 7.2 Table 8.1 Table 8.2 Table B.1 Table B.2

Guide for Managing Hemolysis in Various Circumstances... 7.9 Recommended Standards for Maintenance of the Placement Signal... 7.11 Alarm Levels... 8.1 Automated Impella® Controller Alarm Messages... 8.3 Alternative Guidewires... B.1 Alternative Introducer Sheaths... B.1

INTRODUCTION INTRODUCTION

PURPOSE OF MANUAL This Instructions for Use & Clinical Reference Manual is designed for healthcare professionals. It contains clinical and technical information to guide healthcare professionals in their use of the Impella® 2.5 Catheter with the Automated Impella® Controller. The Impella® System performs life-sustaining functions. To use the system you must understand and follow these instructions. The Impella® System may be used only for its intended purpose. MANUAL OVERVIEW This manual provides instructions for use of the Impella® 2.5 Catheter with the Automated Impella® Controller. The following summarizes the contents of each section of the manual. • S ection 1: Indications, Contraindications, and Potential Adverse Events discusses indications for use of the Impella® Catheter with the Automated Impella® Controller, contraindications, and potential adverse events that may be associated with the use of the system. • S ection 2: Warnings and Cautions discusses the warnings and cautions pertaining to the use of the Impella® Catheter with the Automated Impella® Controller. • S ection 3: The Impella® Catheter and Automated Impella® Controller provides an overview of the system and describes its major components and features. • S ection 4: Using the Automated Impella® Controller describes the controls and various screen types on the Automated Impella® Controller. • Section 5: Using the Automated Impella® Controller with the Impella® Catheter provides the procedures for using the Impella® System. • S ection 6: Clinical Experience provides an overview of clinical studies of the Impella® System. • S ection 7: Patient Management Topics provides key information on various topics related to management of patients with the Impella® Catheter and Automated Impella® Controller. • S ection 8: Automated Impella® Controller Alarms provides a listing of Automated Impella® Controller alarms as well as information on what to do to resolve them. • S ection 9: General System Information contains information including definitions for key terms that appear in the manual, descriptions of the abbreviations and symbols that appear on Impella® Catheter and Automated Impella® Controller components and packaging, technical information pertaining to the Impella® Catheter and Automated Impella® Controller, and instructions on cleaning and storing system components as well as returning components to Abiomed. •A  ppendices at the end of the manual provide supplemental information about topics including the Impella® Limited Service Warranty; Abiomed-approved guidewires and introducers; the Automated Impella® Controller menu structure; and axillary insertion technique.

Impella® 2.5 Catheter with the Automated Impella® Controller

I

1 INDICATIONS, CONTRAINDICATIONS, AND POTENTIAL ADVERSE EVENTS

INDICATIONS (UNITED STATES)... 1.1 CONTRAINDICATIONS (UNITED STATES)... 1.1 POTENTIAL ADVERSE EVENTS (UNITED STATES)...1.2

1

INDICATIONS (UNITED STATES)

INDICATIONS, CONTRAINDICATIONS, AND POTENTIAL ADVERSE EVENTS

The Impella® 2.5 System (Impella® 2.5) is a temporary (≤ 6 hours) ventricular support device indicated for use during high risk percutaneous coronary interventions (PCI) performed in elective or urgent, hemodynamically stable patients with severe coronary artery disease and depressed left ventricular ejection fraction, when a heart team, including a cardiac surgeon, has determined high risk PCI is the appropriate therapeutic option. Use of the Impella® 2.5 in these patients may prevent hemodynamic instability which can result from repeat episodes of reversible myocardial ischemia that occur during planned, temporary coronary occlusions and may reduce peri- and post-procedural adverse events.

CONTRAINDICATIONS (UNITED STATES) Patients with aortic stenosis or other abnormal aortic valve performance may be compromised by the use of the Impella® Catheter. Patients with aortic valve disease should be observed for aortic insufficiency.

• Mural thrombus in the left ventricle • Mechanical aortic valve or heart constrictive device • Aortic valve stenosis/calcification (equivalent to an orifice of 0.6 cm2 or less) • Moderate to severe aortic insufficiency (echocardiographic assessment of aortic insufficiency graded as ≥ +2) • Severe peripheral arterial disease that precludes the placement of the Impella® 2.5

Impella® 2.5 Catheter with the Automated Impella® Controller

1.1

POTENTIAL ADVERSE EVENTS (UNITED STATES) • Acute renal dysfunction

• Myocardial infarction

• Aortic insufficiency • Aortic valve injury

• Need for cardiac, thoracic or abdominal operation

• Atrial fibrillation

• Perforation

• Bleeding

• Renal failure

•C  ardiogenic shock

• Repeat revascularization

• Cardiac tamponade

• Respiratory dysfunction

• Cardiopulmonary resuscitation

• Sepsis

• Cerebral vascular accident / Stroke

• Severe hypotension

• Death

• Thrombocytopenia

• Device malfunction

• Thrombotic vascular (non-CNS) complication

• Failure to achieve angiographic success

• Transient ischemic attack

• Hemolysis

• Vascular injury

•H  epatic failure

• Ventricular arrhythmia, fibrillation or tachycardia

• Insertion site infection • Limb ischemia

1.2

Instructions for Use & Clinical Reference Manual (US)

2 WARNINGS AND CAUTIONS

WARNINGS...2.1 CAUTIONS... 2.3

WARNINGS 2

Fluoroscopy is required to guide placement of the Impella® Catheter. The small placement guidewire must be reliably observed at all times. Be sure that the stopcock on the peel-away introducer or repositioning sheath is always kept in the closed position. Significant bleed back can result if the stopcock is open.

Warnings Warnings alert you to situations that can cause death or serious injury. The red symbol appears before warning messages.

Avoid manual compression of the inlet and outlet areas of the cannula assembly. The sterile components of the Impella® System can be used only if the sterilization indicators show that the contents have been sterilized, the packaging is not damaged, and the expiration date has not elapsed. Do NOT resterilize or reuse the Impella® Catheter. It is a disposable 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 in patient injury, illness, or death. Retrograde flow will occur across the aortic valve if the Impella® Catheter is set at P-level P-0. To prevent malfunction of the locking mechanism of the peel-away introducer, do NOT hold the hemostatic valve while inserting into the artery. To prevent failure of the peel-away introducer, remove the peel-away introducer prior to transport when activated clotting time (ACT) is less than 150 seconds. Do NOT use saline in the purge system. Do NOT use an Impella® System if any part of the system is damaged. To prevent the risk of explosion, do NOT operate the Impella® System near flammable anesthetics. If at any time during the course of support with the Impella® Catheter, the Automated Impella® Controller alarms “Purge Pressure Low” or “Purge System Open,” follow the instructions presented in section 5 of this manual. MR Unsafe - Do NOT subject a patient who has been implanted with an Impella® 2.5 to magnetic resonance imaging (MRI). The strong magnetic energy produced by an MRI machine may cause the Impella® 2.5 components to stop working, and result in injuries to the patient. An MRI may also damage the Impella® 2.5 electronics. Cardiopulmonary support (CPR) should be initiated immediately per hospital protocol if indicated for any patient supported by the Impella® Catheter. When initiating CPR, reduce the Impella® Catheter flow rate. When cardiac function has been restored, return flow rate to the previous level and assess placement signals on the controller. Impella® 2.5 Catheter with the Automated Impella® Controller

2.1

WARNINGS AND CAUTIONS

Use of the Impella® System by trained and experienced practitioners has been associated with improved outcomes. Consequently, the first use of Impella® should be preceded by the completion of a contemporary Abiomed Impella® training program and include on-site proctoring during the first use by Abiomed clinical support personnel certified in the use of Impella®.

During defibrillation, do NOT touch the Impella® Catheter, cables, or Automated Impella® Controller. Power the Automated Impella® Controller using its internal battery if the integrity of the protective earth conductor is questionable. Lithium-ion battery replacement by inadequately trained personnel could result in excessive temperatures, fire, or explosion. Only technicians authorized by Abiomed should remove or change the battery. To avoid risk of electric shock, this equipment must only be connected to a supply mains with protective earth. No modification of this equipment is allowed. Medical electrical equipment needs special precautions regarding EMC and needs to be installed and put into service according to the electromagnetic compatibility (EMC) information provided in section 9 of this manual. During transport, the Automated Impella® Controller may be exposed to stronger electromagnetic disturbance than during in-hospital use. Strong electromagnetic disturbance may cause the Automated 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 user intervention is required. Monitor Impella® Catheter flow and patient hemodynamics to confirm normal operation. The condition will resolve itself once the Automated Impella® Controller is no longer exposed to the disturbance. Portable and mobile RF communications equipment can affect medical electrical equipment. The equipment or system should not be used adjacent to or stacked with other equipment. If adjacent or stacked use is necessary, the equipment or system should be observed to verify normal operation in the configuration in which it will be used. Use of cables, other than those sold by Abiomed, may result in increased emissions or decreased immunity of the Automated Impella® Controller. The Automated Impella® Controller uses RFID (radio frequency identification) to identify and communicate with the purge cassette. Other equipment may interfere with the Automated Impella® Controller even if that other equipment complies with CISPR emission requirements. Infusion through the sideport of the introducer can be done only after all air is removed from the introducer. If performed, the infusion should be done for flushing purposes only and NOT for delivering therapy or monitoring blood pressure.

2.2

Instructions for Use & Clinical Reference Manual (US)

CAUTIONS 2

Patients with aortic stenosis or other abnormal aortic valve performance may be compromised by the use of the Impella® Catheter. Patients with aortic valve disease should be observed for aortic insufficiency. Partial circulatory support with Impella® has been associated with more extensive use of rotational atherectomy. Extensive use of rotational atherectomy has been associated with a periprocedural increase in cardiac biomarkers indicative of myocardial injury. Rotational atherectomy, with or without the use of hemodynamic support, should be used in accordance with the manufacturer’s instructions for use.

Cautions Cautions indicate situations in which equipment may malfunction, be damaged, or cease to operate. The yellow symbol appears before caution messages.

Physicians should exercise 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 the ascending, transverse, or descending aorta. Use only original accessories and replacement parts supplied by Abiomed. Do NOT use damaged or contaminated connector cables. To prevent device failure, do NOT start the Impella® Catheter until the guidewire has been removed. Do NOT remove the Impella® Catheter over the length of the guidewire. When replacing the purge cassette, the replacement process must be completed within 2 minutes. The Impella® Catheter may be damaged if replacement takes longer than 2 minutes. To prevent malfunction of the Automated Impella® Controller, avoid long-term exposure to direct sunlight and excessive heat (40°C). To prevent overheating and improper operation, do NOT block the cooling vents of the Automated Impella® Controller while it is operating. Do NOT kink or clamp the Impella® Catheter or the peel-away introducer. During case start, make sure the yellow luer connection between the purge tubing and Y connector is tightened and not leaking. 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 shorter runtime. After being unplugged, the Automated Impella® Controller will operate for at least 60 minutes after the batteries have been fully charged. Minimize exposure of Impella® System components to sources of electromagnetic interference (EMI). Exposure to sources of EMI, such as cell phones and two-way radios, may cause operational interference. To clear interference, either increase the distance between system components and the EMI source or turn off the EMI source.

Impella® 2.5 Catheter with the Automated Impella® Controller

2.3

WARNINGS AND CAUTIONS

Handle with care. The Impella® Catheter can be damaged during removal from packaging, preparation, insertion, and removal. Do NOT bend, pull, or place excess pressure on the catheter or mechanical components at any time.

Operation of Impella® System components may interfere with the operation of other devices. If interference occurs, increase the distance between the device and system components. Have a backup Automated Impella® Controller, purge cassette, connector cable, and Impella® Catheter available in the unlikely event of a device failure. Do NOT use 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 the potential for air embolism and clot formation. Indwelling introducer sheaths should be internally supported by a catheter or dilator. Dilators and catheters should be removed slowly from the sheath. Rapid removal may damage the valve, resulting in blood flow through the valve. Never advance the guidewire or sheath when resistance is met. Determine the cause of resistance using fluoroscopy and take remedial action. When injecting or aspirating through the sheath, use the sideport only. Operation of the system without heparin in the purge solution has not been tested. In the event that a patient is intolerant to heparin, due to heparin-induced thrombocytopenia or bleeding, physicians should use their clinical judgment to assess the risks versus benefits of operating the Impella® System without heparin. If it is in the best interest of the patient to operate the system without heparin, the dextrose solution is still required, 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® Catheter has not been tested with any alternative anticoagulants in the purge solution.

2.4

Instructions for Use & Clinical Reference Manual (US)

3 THE IMPELLA® CATHETER AND AUTOMATED IMPELLA® CONTROLLER

OVERVIEW...3.1 Reusable System Components...3.2 Single-use System Components...3.2 Impella® Set-up and Insertion Kit...3.2 System Configurations...3.3 IMPELLA® CATHETER...3.4 AUTOMATED IMPELLA® CONTROLLER...3.6 PURGE CASSETTE...3.7 ACCESSORIES...3.9

OVERVIEW 3 THE IMPELLA® CATHETER AND AUTOMATED IMPELLA® CONTROLLER

The Impella® Catheter is an intravascular microaxial blood pump that supports a patient’s circulatory system during PCI procedures in patients at high risk for hemodynamic instability. The Impella® Catheter is inserted percutaneously through the femoral artery and into the left ventricle (see Figure 3.1).

Figure 3.1 Impella® 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 ascending aorta. Physicians and device operators monitor the correct positioning and functioning of the Impella® Catheter on the display screen of the Automated Impella® Controller. This section describes the components of the Impella® Catheter and the Automated Impella® Controller, as well as the accessory components.

Impella® 2.5 Catheter with the Automated Impella® Controller

3.1

REUSABLE SYSTEM COMPONENTS The Impella® System consists of the following reusable components: • Automated Impella® Controller-provides the user interface, alarm indications, and portable battery • Automated Impella® Controller cart-for easy transport of the Automated Impella® Controller

SINGLE-USE SYSTEM COMPONENTS The Impella® System also includes the following single-use components: • Impella® Catheter • Purge cassette • Introducer kit • 0.018 inch, 260 cm placement guidewire • Connector cable IMPELLA® SET-UP AND INSERTION KIT The components of the Impella® System are packaged into a single box called the Impella® Set-up and Insertion kit. Table 3.1 describes the contents of this kit. Table 3.1 Impella® Set-up and Insertion Kit Components

The Impella® Set-up and Insertion kit contains the following:

• Impella® Catheter • 0.018 inch, 260 cm placement guidewire • Connector cable • Purge cassette • Introducer kit »» Peel-away introducer (13 Fr for Impella® 2.5) »» Dilator (13 Fr for Impella® 2.5) »» 18 G Seldinger needle »» 12 cc syringe »» 0.035 inch stiff access guidewire

3.2

Instructions for Use & Clinical Reference Manual (US)

SYSTEM CONFIGURATIONS 3

D20 D5

THE IMPELLA® CATHETER AND AUTOMATED IMPELLA® CONTROLLER

Figure 3.2 illustrates how the Automated Impella® Controller connects to the Impella® Catheter and accessory components in the initial set-up configuration.

Dextrose Solution Automated Impella® Controller

Impella® Catheter

Purge Cassette

Connector Cable

Y-Connector

Figure 3.2 Set-up Configuration of the Automated Impella® Controller, Impella® Catheter, and Accessories

Figure 3.3 illustrates the standard configuration of the Impella® Catheter, Automated Impella® Controller, and accessory components. D5

Dextrose Solution

Sodium Chloride (NaCl) Solution in Pressure Bag

Automated Impella® Controller

Impella® Catheter

Purge Cassette

Connector Cable

Y-Connector

Figure 3.3 S  tandard Configuration of the Automated Impella® Controller, Impella® Catheter, and Accessories

Impella® 2.5 Catheter with the Automated Impella® Controller

3.3

IMPELLA® CATHETER The Impella® Catheter is an intravascular microaxial blood pump that delivers up to 2.5 liters of blood per minute from the left ventricle into the aorta during PCI procedures in patients at high risk for hemodynamic instability. Figure 3.4 illustrates the Impella® Catheter. Table 3.2 describes each component from the pigtail at one end to the check valve on the other end. Pigtail Inlet Area Radiopaque Marker EasyGuide Lumen

Outlet Area Cannula

Catheter Shaft

Motor Housing Open Pressure Area Check Valve

Red Pressure Sidearm

Pressure Reservoir Clear Sidearm

Repositioning Unit

Infusion Filter

Red Impella® Plug

Figure 3.4 Impella® Catheter Table 3.2 Impella® Catheter Components

3.4

Component

Description

Pigtail

The 6 Fr pigtail is attached to the cannula at the distal end of the inlet area. It assists with stabilizing the catheter in the correct position in the left ventricle.

Inlet area

The inlet area, located at the distal tip of the cannula, has four openings (windows) that allow blood to be drawn into the inlet and channeled through the cannula.

Radiopaque marker

The radiopaque marker on the catheter shaft is visible with fluoroscopy and, when properly positioned, appears at the level of the aortic valve annulus.

Cannula

The cannula (12 Fr for the Impella® 2.5) has a spiral-shaped reinforced body that is shaped in a 145-degree angle. The cannula is made of nitinol and covered in polyurethane.

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, which runs from the tip of the pigtail through the outlet area of the cannula, facilitates loading the catheter onto the guidewire Instructions for Use & Clinical Reference Manual (US)