Impella 5.5® with SmartAssist ® For Use During Cardiogenic Shock Instructions for Use & Clinical Reference Manual IMPORTANT NOTICE: Read this entire manual before using the Automated Impella Controller and Impella Circulatory Support System (Impella System). The Impella 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. ©2020 Abiomed®, Inc. All rights reserved. The ABIOMED logo, ABIOMED, Impella 5.5® with SmartAssist® and Recovering Hearts. Saving Lives. are registered trademarks of ABIOMED, Inc. in the U.S. and in certain foreign countries. The following information pertains to the Emergency Use Authorization (EUA) during the Coronavirus Disease 2019 (COVID-19) outbreak granted by the FDA and does not apply to the indications approved under the PMA listed on Page 1.1: • The Impella 5.5 with SmartAssist System has neither been cleared or approved for use by healthcare providers (HCP) in the hospital setting to provide temporary (≤ 14 days ) LV unloading and support in critical care patients with confirmed Coronavirus Disease 2019 (COVID-19) infection who are undergoing extracorporeal membrane oxygenation (ECMO) treatment and who develop pulmonary edema while on veno-arterial (V-A) ECMO support or late cardiac decompensation from myocarditis while on veno-venous (V-V) ECMO support. For purposes of this EUA, “critical care” patients refer to patients in the intensive care unit (ICU) who have confirmed COVID-19 infection. • The Impella 5.5 with SmartAssist System has been authorized for the above emergency use by FDA under an EUA; and, • The Impella 5.5 with SmartAssist System has been authorized for the above emergency use only for the duration of the declaration that circumstances exist justifying the authorization of the emergency use of medical devices under section 564(b)(1) of the Act, 21 U.S.C. § 360bbb-3(b)(1), unless the authorization is terminated or revoked sooner. IMPELLA 5.5® WITH SMARTASSIST® FOR USE DURING CARDIOGENIC SHOCK INSTRUCTIONS FOR USE AND CLINICAL REFERENCE MANUAL (UNITED STATES ONLY) Rx Only Abiomed, Inc. 22 Cherry Hill Drive Danvers, MA 01923 978-646-1400 (voice) 978-774-7240 (fax) [email protected] (email) Abiomed Europe GmbH Neuenhofer Weg 3 52074 Aachen, Germany +49 (0) 241 8860-0 (voice) +49 (0) 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 July 2020 Document No. 0550-9002 rC Page intentionally left blank TABLE OF CONTENTS Introduction ............................................................................................. 9 Cardiac Shock after Acute Myocardial Infarction - Summary of Primary Clinical Studies ......................................................................................... 6.41 1 INDICATIONS, CONTRAINDICATIONS, AND POTENTIAL ADVERSE EVENTS Summary of Supplemental Clinical Information ........................................ 6.47 Indications (United States) ....................................................................... 1.1 Cardiac shock after open heart surgery - summary of primary Contraindications (United States) ............................................................. 1.1 clinical studies ......................................................................................... 6.58 Potential Adverse Events (United States) .................................................. 1.1 Summary of Supplemental Clinical Information ........................................ 6.64 Clinical Experience Overview for Cardiogenic Shock in the Setting of 2 WARNINGS AND CAUTIONS Cardiomyopathy, Myocarditis, and Peripartum Cardiomyopathy .............. 6.74 Warnings ................................................................................................. 2.1 Cautions .................................................................................................. 2.3 7 PATIENT MANAGEMENT TOPICS Patient Management Overview ................................................................ 7.1 3 THE IMPELLA CATHETER AND AUTOMATED IMPELLA CONTROLLER The Need for Early Identification of Cardiogenic Shock Patients ............... 7.1 Overview ................................................................................................. 3.1 General Patient Care Considerations ....................................................... 7.3 Impella Catheter ...................................................................................... 3.3 Transport Within the Hospital .................................................................. 7.3 Automated Impella Controller .................................................................. 3.5 Right Heart Failure ................................................................................... 7.4 Purge Cassette ......................................................................................... 3.6 ECG Interference ...................................................................................... 7.4 Accessories .............................................................................................. 3.8 Latex ........................................................................................................ 7.4 Use of Echocardiography for Positioning of the Impella Catheter.............. 7.4 4 USING THE AUTOMATED IMPELLA CONTROLLER Understanding and Managing Impella Catheter Position Alarms .............. 7.11 Overview ................................................................................................. 4.1 Impella Stopped ....................................................................................... 7.18 Automated Impella Controller Features .................................................... 4.1 Suction .................................................................................................... 7.18 Home Screen ............................................................................................ 4.5 Hemolysis ................................................................................................ 7.18 Placement Screen ..................................................................................... 4.8 Enabling Purge Flow Notifications ............................................................ 7.20 Purge Screen ............................................................................................ 4.10 Disabling Audio Alarms ............................................................................ 7.20 Infusion History Screen ............................................................................ 4.11 Surgical Mode .......................................................................................... 7.20 LVEDP Trend Screen ................................................................................. 4.12 Operating the Impella Catheter without Heparin in the Purge Solution .... 7.21 Mobile Operation ..................................................................................... 4.13 Timed Data Recording .............................................................................. 7.21 5 USING THE AUTOMATED IMPELLA CONTROLLER WITH Operating the Impella Catheter in Electromagnetic Fields ........................ 7.21 THE IMPELLA CATHETER Transferring from the Automated Impella Controller to a New AIC .......... 7.23 Pre-support Evaluation ............................................................................ 5.1 Emergency Shutdown Procedure .............................................................. 7.24 Startup ..................................................................................................... 5.2 Anti-Coagulation Therapy with Impella Heparin Infusion ......................... 7.25 Turning on the Automated Impella Controller ........................................... 5.3 Case Start ................................................................................................ 5.4 8 AUTOMATED IMPELLA CONTROLLER ALARMS Axillary Insertion of the Impella 5.5 Catheter ........................................... 5.11 Alarms Overview ...................................................................................... 8.1 Alternate Insertion Technique Using a Sidearm Graft & Silicone Plugs ...... 5.15 Alarm Message Summary ......................................................................... 8.3 Direct Aortic Insertion .............................................................................. 5.17 9 GENERAL SYSTEM INFORMATION Positioning & Starting Impella 5.5 with SmartAssist Catheter .................. 5.19 Terminology, Abbreviations, and Symbols ................................................ 9.1 Use of the Repositioning Unit ................................................................... 5.20 Automated Impella Controller Mechanical Specifications ......................... 9.3 P-Level ..................................................................................................... 5.21 Automated Impella Controller Electrical Specifications ............................. 9.3 Adjusting the LV Placement Signal ........................................................... 5.22 Equipment Design .................................................................................... 9.4 Entering Cardiac Output........................................................................... 5.24 Equipment Classifications .......................................................................