DOCSLIB.ORG

Recovering Hearts. Saving Lives

Total Page：16

File Type：pdf, Size：1020Kb

Download full-text PDF Read full-text
Recovering Hearts. Saving Lives Recovering Hearts. Saving Lives. Michael Minogue Chairman, President, & CEO January 13, 2020 Recovering Hearts. Saving Lives. 2 LEGAL DISCLAIMERS This presentation contains forward-looking statements, including, without limitation, statements regarding development of Abiomed's existing and new products, the Company's progress toward commercial growth, and future opportunities, the Company’s guidance for future financial performance and expected regulatory approvals. Each forward-looking statement contained in this presentation is subject to risks and uncertainties that could cause actual results to differ materially from those projected in such statement, including uncertainties associated with development, testing and related regulatory approvals; the potential for future losses; the impact of complex manufacturing processes and high quality requirements; dependence on limited sources of supply; competition; technological change; government regulation; third-party reimbursement to the Company’s customers; litigation matters; future capital needs and uncertainty of additional financing, and other risks and challenges detailed in the Company's filings with the Securities and Exchange Commission (“SEC”), including the most recently filed Annual Report on Form 10-K and the filings subsequently filed with or furnished to the SEC. Readers are cautioned not to place undue reliance on any forward-looking statements, which speak only as of the date of this presentation. The Company undertakes no obligation to publicly release the results of any revisions to these forward-looking statements that may be made to reflect events or circumstances that occur after the date of this presentation or to reflect the occurrence of unanticipated events, whether as a result of new information, future events or otherwise, unless otherwise required by law. U.S. Food and Drug Administration Approvals ● The Impella 2.5, Impella CP and Impella CP with SmartAssist are indicated for providing temporary (< 6 hours) ventricular support during elective or urgent high risk percutaneous coronary interventions (PCI) performed in hemodynamically stable patients with severe coronary artery disease, when a heart team, including a cardiac surgeon, has determined high risk PCI is the appropriate therapeutic option. Use of the Impella 2.5, Impella CP and Impella CP with SmartAssist 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. ● The Impella 2.5, Impella CP, Impella CP with Smart Assist, Impella 5.0, Impella 5.5 with SmartAssist and Impella LD Catheters, in conjunction with the Automated Impella Controller, are temporary ventricular support devices intended for short term use (≤4 days for the Impella 2.5, Impella CP and Impella CP with SmartAssist and ≤14 days for the Impella 5.0, Impella 5.5 with SmartAssist and Impella LD) and indicated for the treatment of ongoing cardiogenic shock that occurs immediately (<48 hours) following acute myocardial infarction or open heart surgery, or in the setting of cardiomyopathy, including peripartum cardiomyopathy, or myocarditis as a result of isolated left ventricular failure that is not responsive to optimal medical management and conventional treatment measures (including volume loading and use of pressors and inotropes, with or without IBP). The intent of the Impella Support Systems therapy is to reduce ventricular work and to provide the circulatory support necessary to allow heart recovery and early assessment of residual myocardial function. ●The Impella RP® is indicated for providing circulatory assistance for up to 14 days in patients with a with a body surface area ≥ 1.5 m2 who develop acute right heart failure or decompensation following left ventricular assist device implantation, myocardial infarction, heart transplant, or open-heart surgery. In addition, there are other WARNINGS and PRECAUTIONS associated with Impella devices. Visit http://www.abiomed.com/important-safety-information to learn more. Impella ECPTM, Impella BTRTM, and The Impella PediatricTM are in development and are not approved for use or sale in the US. The ABIOMED logo, ABIOMED, Impella 2.5, Impella CP, Impella RP, Impella 5.0, Impella LD, Impella 5.5 SmartAssist Platform, and Recovering Hearts. Saving Lives are registered trademarks of Abiomed, Inc. in the U.S.A. and certain foreign countries. Impella ECP, Impella BTR, cVAD Study, and Automated Impella Controller are pending trademarks of Abiomed, Inc.” FOR INVESTORS ONLY Recovering Hearts. Saving Lives. 3 ABIOMED PRINCIPLES RECOVERING HEARTS & SAVING LIVES GROWING SHAREHOLDER VALUE Recovering hearts and saving lives is the Growing shareholder value rewards our founding principle and guiding compass of our investors and helps to ensure the company’s organization. This is our highest recognition of financial stability, allowing for the continued success. Recovering and preserving our pursuit of our mission. Shareholder value is patients’ hearts enables them to return home to driven by executing our goals and achieving their families and enjoy an improved quality of positive financial results. For employees, growth life. of shareholder value provides financial security for our families and the pursuit of happiness for our future. LEADING IN TECHNOLOGY & INNOVATION SUSTAINING A WINNING CULTURE We are committed to providing patients and Patients First. Our patients and customers are health care providers with the highest quality the motivation for all that we do and achieving devices and optimal cost-effective solutions. We our mission is dependent on their well-being. We accomplish this through the relentless exploration must always act with integrity and honor and of new ideas and approaches that allow us to demand the best of ourselves. We work hard, address new clinical challenges for our have faith in each other, and have fun customers and patients. celebrating the patient success stories. FOR INVESTORS ONLY Recovering Hearts. Saving Lives. 4 THE ABIOMED MISSION To recover heart muscle and save lives with percutaneous heart pump technologies for high-risk patients and enable better, minimally invasive procedures. Elective Urgent Emergent FOR INVESTORS ONLY Recovering Hearts. Saving Lives. 5 THE ABIOMED MISSION Impella RP Impella CP Bi-Ventricular Bi-Ventricular Impella Support Impella Support DR. BABU ELADASARI HEART ATTACK (AMI) WITH CARDIOGENIC SHOCK FOR INVESTORS ONLY Recovering Hearts. Saving Lives. 6 ABIOMED AT A GLANCE (NASDAQ: ABMD) EUROPEAN HQ: AACHEN, GERMANY 71,000 sq. ft. with Manufacturing JAPANESE HQ: TOKYO First Patient Treated: 2017 GLOBAL HQ: MASSACHUSETTS, USA 200,000+ sq. ft. with Manufacturing Founded in 1981 Global Employees ~1,500 Key Medical Device Countries: Impella® Products Next Tier Opportunities: Impella® Products Approved; Approved; ABMD Direct Distribution/Coverage; Dedicated No / Limited Distribution Coverage Impella Reimbursement FOR INVESTORS ONLY Recovering Hearts. Saving Lives. 7 IMPELLA® HEART PUMPS: BREAKTHROUGH TECHNOLOGY ✓ Exclusive FDA Approvals: High-Risk PCI (2015) AMI Cardiogenic Shock (2016) Impella RP® for Right Heart Failure (2017) Cardiomyopathy Shock (2018) Expanded High-Risk PCI; SmartAssist® (2018) ✓ Medicare Designated DRG Codes: CMS reimbursement for implant, explant, transfer & biventricular Impella at 1,400+ US hospitals ✓ Approved in Europe (CE Mark 2002) Approved in Japan (PMDA 2016) ✓ 8 Clinical Guidelines; >650 publications ✓ >$525M & 20 years of R&D investment, >140,000 patients treated world-wide 759 patents & 649 pending January 2020 FOR INVESTORS ONLY Recovering Hearts. Saving Lives. 8 ABIOMED: THE HEART RECOVERY COMPANY 1. Creating the New Field of Heart Recovery with the Impella® Heart Pump Platform 2. Solving a Clinical Crisis for Large and Growing Patient Populations RECOVERING HEARTS. SAVING LIVES.® 4. Sustaining Long-term Growth Driven by Innovation 3. Improving Patient Outcomes and Strong Execution by Leading in Clinical Research, Education and 24/7 Hospital Support FOR INVESTORS ONLY Recovering Hearts. Saving Lives. 99 IMPELLA® HEART PUMPS SUPPORT AND RECOVER HEART MUSCLE AND ENABLE MINIMALLY INVASIVE PROCEDURES IABP PERCUTANEOUS ECMO IMPELLA (1976*) (1980S) (2008) Percutaneous Insertion Perfuses the Body Percutaneous Insertion Not a Heart Pump Loads the Heart Unloads the Heart * IABP grandfathered in 1976 FOR INVESTORS ONLY Recovering Hearts. Saving Lives. 10 TREATING THE HEART – OPEN OR PERCUTANEOUS? OPEN CHEST PROCEDURES PERCUTANEOUS PROCEDURES HEART SURGERY SUITE CATHERIZATION LAB (CATH) WITH HEART & LUNG MACHINE WITH IMPELLA SUPPORT (OPEN CHEST ECMO) FOR HIGH-RISK PCI & CARDIOGENIC SHOCK FOR INVESTORS ONLY Recovering Hearts. Saving Lives. 11 IMPELLA® HEART PUMPS ENABLE HIGH-RISK PROCEDURES PATIENT HEMODYNAMIC METRICS UNLOADS THE HEART MUSCLE DURING HIGH-RISK PCI DURING PCI Impella CP On MAP 110 mmHg -8% -10% -12% 97 mmHg MAP 86 mmHg -15% -23% -51% Organ failure 42 mmHg Case Balloon Stent 15 sec 30 sec 45 sec Start Inflation Mary Hanel Impella CP® Patient * Physiologic computational modeling of patient, Am J Physiol 1991;260 : H146-H157 FOR INVESTORS ONLY Recovering Hearts. Saving Lives. 12 THE IMPELLA® HEART PUMP CATHETER PLATFORM FEMORAL INSERTION AXILLARY INSERTION 24/7 Support Onsite, On-call, Online Impella 2.5® Impella LD® Impella CP® ® with SmartAssist >400 Global Field Reps Clinical Support Impella Connect® Center AIC
Load more

Recommended publications
  • 2021 Annual Report Abiomed Fy 2021 Annual Report Annual 2021 Fy
    FY 2021 ANNUAL REPORT ABIOMED FY 2021 ANNUAL REPORT I AM ABIOMED I AM HEART RECOVERY 81% $848 82% $651 83% $513 83% 18 19 20 21 $400 Gross Margin Gross DOLLARS IN MILLIONS IN DOLLARS Net Cash Balances* 17FY 84% $277 17 18 19 20 21 FY 16 $848 +1% $230 $841 +9% $249 $769 +30% $225 $594 +33% 18 19 20 21 $157 DOLLARS IN MILLIONS IN DOLLARS DOLLARS IN MILLIONS IN DOLLARS Total Revenue Total 17 18 19 20 21 $445 +35% 17FY $90 GAAP Operating Income Operating GAAP FY Fiscal Year Ends March 31st Ends March Fiscal Year FY 2021 - COVID YEAR - COVID FY 2021 FINANCIAL PERFORMANCE * Net cash balances are defined as total cash, short-term and long-term marketable securities. The Company currently has no debt. 1 996 940 1,150 789 720 850 568 541 653 18 19 20 21 470 311 317 18 19 20 21 411 241 274 PATENTS PENDING PATENTS Total Impella Publications Total FY 17 FY 17 Total Abiomed Patent Portfolio Abiomed Patent Total $122 1,509 21 $99 1,441 $94 1,362 DEVICE PROGRESS ® 18 19 20 21 $75 1,197 18 19 20 DOLLARS IN MILLIONS IN DOLLARS $66 1,138 Sites Impella U.S. Total FY 17 FY 17 Research & Development Spend & Development Research IMPELLA YEAR - COVID FY 2021 31st Ends March Fiscal Year FY21 HIGHLIGHTS Q1 Q2 4/29/2020 5/27/2020 7/16/2020 Abiomed Expands Abiomed Hosts Virtual FDA Approves Data Product Portfolio with Clinical Data and Streaming from the Acquisition of Cardio- Innovation Day Impella Console, pulmonary Support Setting the Stage for Technology (ECMO) Artificial Intelligence 6/01/2020 Algorithms FDA Issues 6/05/2020 5/19/2020 EMERGENCY USE FDA Approves
    [Show full text]
  • The Impella Left Ventricular Support System
    The Impella® Left Ventricular Support System A New Way to Treat Left Heart Failure A Guide for Families and Caregivers About This Booklet This booklet is for people like you who have a family member, relative or another significant person in your life suffering from failure of the left side of the heart (left heart failure), who have not been helped by medication or other treatments. The doctor treating your family member, relative or significant other can explain how the Impella® Left Ventricular Support System can be used to treat this life threatening condition. The booklet explains: • How the heart works • What heart failure means • What the Impella® Support System is • What are the possible risks and benefits of someone having this treatment Please read this booklet carefully. For your convenience, a Glossary is provided in the front of the Guide. Terms that are explained in the Glossary are in bold italics in the text. If you have questions about the Impella® Support System that are not answered in this booklet, please visit our website at www.abiomed.com. This booklet is intended for general information only. Your doctor should always be your primary source of information about your heart condition and your general health. Impella® Support System Patient Brochure Page 2 of 17 Table of Contents Glossary .......................................................................................................................................... 4 Treating the Heart with the Impella® Support System ................................................................... 5 The Impella® Support System ..................................................................................................... 5 Who Should Use the Impella® Support System .......................................................................... 6 The Impella® Support System is Not Right for Everyone .............................................................. 7 Who May Not be Able to be Treated with the Impella® Support System .................................
    [Show full text]
  • Percutaneous Ventricular Assist Devices Original Effective Date: 02/27/13
    Subject: Percutaneous Ventricular Assist Devices Original Effective Date: 02/27/13 Policy Number: Revision Date(s): 7/27/2016, 12/10/2019 MCP-132 Review Date: 12/16/15, 7/27/16, 6/22/17, 3/8/18, 12/10/19 MCPC Approval Date: 3/8/18, 12/10/19 DISCLAIMER This Molina Clinical Policy (MCP) is intended to facilitate the Utilization Management process. It expresses Molina's determination as to whether certain services or supplies are medically necessary, experimental, investigational, or cosmetic for purposes of determining appropriateness of payment. The conclusion that a particular service or supply is medically necessary does not constitute a representation or warranty that this service or supply is covered (i.e., will be paid for by Molina) for a particular member. The member's benefit plan determines coverage. Each benefit plan defines which services are covered, which are excluded, and which are subject to dollar caps or other limits. Members and their providers will need to consult the member's benefit plan to determine if there are any exclusion(s) or other benefit limitations applicable to this service or supply. If there is a discrepancy between this policy and a member's plan of benefits, the benefits plan will govern. In addition, coverage may be mandated by applicable legal requirements of a State, the Federal government or CMS for Medicare and Medicaid members. CMS's Coverage Database can be found on the CMS website. The coverage directive(s) and criteria from an existing National Coverage Determination (NCD) or Local Coverage Determination (LCD) will supersede the contents of this Molina Clinical Policy (MCP) document and provide the directive for all Medicare members.1 2 DESCRIPTION OF PROCEDURE/SERVICE/PHARMACEUTICAL 2-5 Percutaneous ventricular assist devices (pVADs) have been developed for short-term use (4-6 hours) in patients who require acute circulatory support.
    [Show full text]
  • Acute Mechanical Circulatory Support Right Ventricular Support Devices
    Acute Mechanical Circulatory Support Right Ventricular Support Devices Navin K. Kapur, MD, FACC, FSCAI, FAHA Associate Professor, Department of Medicine Interventional Cardiology & Advanced Heart Failure Programs Executive Director, The Cardiovascular Center for Research & Innovation Right Heart Failure Always Worsens Mortality RV Function in Shock is Poorly Understood RV Shock is just as bad as LV Shock Jacobs A et al. JACC 2003 Why is Univentricular Shock Uncommon? The RV is Highly Sensitive to Increased Afterload Haddad and Hunt et al. Circulation 2008;117;1717-1731 HemodynamicsEffect of elevated pulmonary of capillary the wedge RV pressure-PA- (PCWP)LV Axis on pulmonary vascular resistance-compliance relationship (RPA-CPA). Pulm. Venous Congestion PA Compliance PCWP = PA Resistance Tedford R J et al. Circulation 2012;125:289-297 PA Pressure Alone is an Insufficient Marker of RV Failure in PH and Heart Failure Hemodynamic Formulas to Assess RV Function >0.63 (RVF after LVAD) [14] RA / PCWP Cardiac Filling Pressures >0.86 (RVF in Acute MI)[31] <1.85 (RVF after LVAD) [42] PA Pulsatility Index (PASP-PADP) / RA <1.0 (RVF in Acute MI) [41] Pulmonary Vascular mPA-PCWP / CO >3.6 (RVF after LVAD) [16] Resistance Trans-pulmonary Gradient mPA-PCWP Undetermined [36] Diastolic Pulmonary PAD - PCWP Undetermined [36, 37] Gradient <15 (RVF after LVAD) [16] RV Stroke Work (mPAP-RA) x SV x 0.0136 <10 (RVF after Acute MI) [40] RV Stroke Work Index (mPA-RA)/ SV Index <0.3-0.6 (RVF after LVAD) [14,42] Pulmonary Artery SV / (PASP-PADP) <2.5 (RVF in Chronic Heart Failure) [39] Compliance Pulmonary Artery PASP/ SV Undetermined [38] Elastance Right atrial (RA); Pulmonary artery (PA); PA systolic pressure (PASP); PA diastolic pressure (PADP); mean PA pressure (mPAP); Pulmonary capillary wedge pressure (PCWP); Right ventricular failure (RVF); Left ventricular assist device (LVAD); Myocardial infarction (MI); Stroke volume (SV) Kapur, Esposito, and Burkhoff et al Circulation 2017 From Pulsatile Load to PA Pulsatility RAP = 22 RAP = 15 RAP = 7 Kiernan and Kapur.
    [Show full text]
  • Abiomed Introduces 3Rd Generation Impella CP® Heart Pumps at SCAI 2017
    May 9, 2017 Abiomed Introduces 3rd Generation Impella CP® Heart Pumps at SCAI 2017 Designed to Enable Ease of Use in High-Risk Percutaneous Coronary Interventions and in the ICU DANVERS, Mass., May 09, 2017 (GLOBE NEWSWIRE) -- Abiomed, Inc. (NASDAQ:ABMD), a leading provider of breakthrough heart support and recovery technologies, announced the debut of the 3rd Generation Impella CP heart pump at the Annual meeting of the Society for Cardiovascular and Angiography Interventions (SCAI 2017) in New Orleans, LA. The technology offers new features for optimal care during a percutaneous coronary intervention (PCI) in high-risk patients known as a Protected PCI, and for patients being treated with Impella in the intensive care unit (ICU). The 3rd Generation Impella CP is a member of the Impella family of heart pumps which have the unique ability to unload the heart and enable native heart recovery, potentially allowing patients to return home with their own hearts. As the world's smallest heart pump, the Impella platform has supported more than 50,000 patients in the U.S. alone, and is the only Food and Drug Administration (FDA)-approved percutaneous ventricular assist device (pVAD) indicated as safe and effective for PCI in high-risk patients1 and patients with Acute Myocardial Infarction complicated by Cardiogenic Shock (AMICS)2. A photo accompanying this announcement is available at http://www.globenewswire.com/NewsRoom/AttachmentNg/2c12e27d-b221-4a86-95d9-a2a8db4b4fac Higher flows and ability to maintain access to arteriotomy There are several new features on the Impella CP 3rd Generation that simplify patient management: To maximize unloading of the heart in the cath lab, this next generation heart pump enables higher flow.
    [Show full text]
  • Quick Reference and Troubleshooting Guide Impella Heart
    Quick Reference and Troubleshooting Guide Impella® Heart Pump with Automated Impella® Controller Function Impella Heart Pump Positioning Purge System Management This is not a replacement for the Instructions for Use Manual This troubleshooting guide is for use with the Automated Impella Controller with Software v6 and higher Table of Contents INDICATIONS AND SAFETY INFORMATION ..................................................... 4 AUTOMATED IMPELLA® CONTROLLER ............................................................. 6 IMPELLA 2.5® AND IMPELLA CP® ....................................................................... 8 IMPELLA 5.0® AND IMPELLA LD® .....................................................................12 IMPELLA RP® .......................................................................................................16 IMAGING THE IMPELLA DEVICES .....................................................................20 TROUBLESHOOTING ...........................................................................................24 3 Indications and Safety Information INDICATIONS FOR USE High-Risk PCI The Impella 2.5®, Impella CP® and Impella CP® with SmartAssist® Systems are temporary (≤ 6 hours) ventricular support devices indicated for use during high-risk percutaneous coronary interventions (PCI) performed in elective or urgent, hemodynamically stable patients with severe coronary artery disease, when a heart team, including a cardiac surgeon, has determined high-risk PCI is the appropriate therapeutic option. Use of
    [Show full text]
  • How Does an Impella Device Help My Heart?
    Ask theExpert How Does an Impella Device Help My Heart? Taking steps to care for What is the Impella while a cardiologist require surgery, it is and protect your heart are Device? intervenes in opening the usually performed in the important. Sometimes heart attack artery with catheterization (cath) lab. matters of health are out of The Impella Device is a angioplasty or stenting, your control and when you ventricular assist device, etc. Another use for the Also, the advanced Hybrid do need extra help caring also known as the world’s Impella device is in patients Operating Rooms at NEA for your heart, you want smallest heart pump. In that have critical blockage Baptist allow for cath to know that your doctors fact, the Impella is 1/100th of coronary arteries, but procedures in the surgical have the experience and the size of a human heart the heart is weak or the suite, physicians are able technology necessary to and is smaller than the blockage is in a high to save even more time by provide you with the best width of a pencil. The risk position. Again, this having the ability to insert care possible. device assists the heart in Impella support allows for the device and to then go pumping blood and the a safer procedure. These straight into surgery when The new NEA Baptist insertion of the device patients would otherwise necessary. medical campus places a typically does not require have a high risk procedure special emphasis on heart surgery. or be turned down What are the benefits of care – from wellness and altogether.
    [Show full text]
  • IMPELLA® Or Extracorporeal Membrane Oxygenation for Left Ventricular Dominant Refractory Cardiogenic Shock
    Journal of Clinical Medicine Article IMPELLA® or Extracorporeal Membrane Oxygenation for Left Ventricular Dominant Refractory Cardiogenic Shock Guillaume Schurtz 1,2,†, Natacha Rousse 3,†, Ouriel Saura 1 , Vincent Balmette 1, Flavien Vincent 2, Nicolas Lamblin 1,4, Sina Porouchani 2, Basile Verdier 1, Etienne Puymirat 5, Emmanuel Robin 3, Eric Van Belle 2, André Vincentelli 3, Nadia Aissaoui 6,Cédric Delhaye 2, Clément Delmas 7 , Alessandro Cosenza 2, Laurent Bonello 8,9, Francis Juthier 3, Mouhamed Djahoum Moussa 3 and Gilles Lemesle 1,4,* 1 Cardiac Intensive Care Unit, Heart and Lung Institute, CHU Lille, 59000 Lille, France; [email protected] (G.S.); [email protected] (O.S.); [email protected] (V.B.); [email protected] (N.L.); [email protected] (B.V.) 2 Department of Interventional Cardiology for Coronary, Valves and Structural Heart Diseases, CHU Lille, Institut Coeur Poumon, Cardiology, 59000 Lille, France; fl[email protected] (F.V.); [email protected] (S.P.); [email protected] (E.V.B.); [email protected] (C.D.); [email protected] (A.C.) 3 Department of Cardiac Surgery, Institut Cœur Poumon, CHU Lille, INSERM U1011, Institut Pasteur de Lille, Université de Lille, 59000 Lille, France; [email protected] (N.R.); [email protected] (E.R.); [email protected] (A.V.); [email protected] (F.J.); [email protected] (M.D.M.) 4 Heart and Lung Institute, University Hospital of Lille, Institut Pasteur
    [Show full text]
  • Impella® Procedure with SINGLE-ACCESS TECHNIQUE Procedural Steps
    Impella® Procedure with SINGLE-ACCESS TECHNIQUE Procedural Steps Abiomed’s Impella CP Introducer* was recently FDA cleared1, and is being released to users. It has a 14 French (F) sheath, which permits placement of the Impella CP’s pump (motor and housing). However, after the Impella CP pump is positioned in the ventricle, its smaller Impella 9 F catheter shaft remains in the introducer. The size difference between the 14 F sheath and 9 F catheter shaft permits the insertion of a second introducer sheath (up to 7 F) adjacent to the 9 F catheter shaft, using a new technique. The additional sheath can be used to pass other catheters, including interventional devices. Use of the new technique, called the “single-access approach”, results in one access site for both the Impella CP device and an additional catheter. PCI Access Site Options Only for use with the Impella CP 14 F introducer sheath Impella CP® Heart Pump SINGLE-ACCESS TECHNIQUE Procedural Steps After you have placed the Impella catheter using access best practices... PROCEDURE STEPS Step 1. Aspirate and flush Impella sheath PCI Access Site Options Place needle through diaphragm of Impella 14F sheath at the 10:00 Step 2. or 2:00 position to allow for placement of 0.035” guidewire Secure the Impella catheter to Step 3. avoid any movement and insert PCI sheath over 0.035” guidewire Step 4. Perform Protected PCI Remove PCI sheath at end of Step 5. procedure, while securing the Impella catheter Remove Impella and close access site per recommendations Single-Access TROUBLESHOOTING with
    [Show full text]
  • Advanced Heart Failure: Mechanical Circulatory Support and Heart Transplantation
    Advanced Heart Failure: Mechanical Circulatory Support and Heart Transplantation By Douglas Jennings, Pharm.D., FCCP, FAHA, FACC, FHFSA, BCPS; and Phillip Weeks, Pharm.D., BCPS, BCCP Reviewed by Christopher Ensor, Pharm.D., FCCP, FAST, BCPS; Ohoud Almalki, Pharm.D., BCPS, ASH-CHC, CLS; and Debra J. Barnette, Pharm.D., FCCP, BCPS, BCACP, CDE LEARNING OBJECTIVES 1. Evaluate pharmacotherapy for the patient awaiting left ventricular assist device (LVAD) or heart transplantation (HT). 2. Design optimal therapy for patients receiving extracorporeal membrane oxygenator support. 3. Develop effective thromboprophylactic strategies for patients receiving percutaneous ventricular assist device support. 4. Develop effective treatment for patients with complications of durable LVAD therapy. 5. Design optimal pharmacotherapy for the patient recovering from HT. INTRODUCTION ABBREVIATIONS IN THIS CHAPTER Despite advances in pharmacotherapy and device technology (e.g., ACT Activated clotting time implantable cardioverter-defibrillator and cardiac resynchronization aPTT Activated partial thromboplastin time therapy), heart failure (HF) remains a leading cause of morbidity and CF-LVAD Continuous-flow left ventricular mortality in both the United States and around the world. This mor- assist device bidity and mortality is particularly prominent with advanced HF (i.e., CMV Cytomegalovirus stage D), which carries an about 90% 1-year mortality rate without CVP Central venous pressure heart transplantation (HT) or left ventricular assist device (LVAD) ECMO Extracorporeal
    [Show full text]
  • Abiomed Impella RP Information For
    Impella RP® System with the Automated Impella Controller Circulatory Support System INSTRUCTIONS FOR USE & CLINICAL REFERENCE MANUAL (United States only) IMPORTANT NOTICE: Read this entire manual before using the Automated Impella Controller and Impella RP Circulatory Support System (Impella RP System). The Impella RP 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, Impella 2.5, Impella CP, Impella CP with SmartAssist, Impella 5.0, Impella 5.5 with SmartAssist, Impella LD, Impella RP, Impella Connect 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 COVID‐19 outbreak granted by the FDA and does not apply to the indications approved under the PMA (i.e., providing temporary right ventricular support for up to 14 days in patients with a body surface area > 1.5 m2 , who develop acute right heart failure or decompensation following left ventricular assist device implantation, myocardial infarction, heart transplant, open‐heart surgery): The Impella RP has neither been cleared or approved for use by healthcare providers (HCP) in the hospital setting for providing temporary right ventricular support for up to 14 days in critical care patients with a body surface area ≥1.5 m2, for the treatment of acute right heart failure or decompensation caused by complications related to Coronavirus Disease 2019 (COVID‐19), including pulmonary embolism (PE); The Impella RP has been authorized for the above emergency use by FDA under an EUA; and, The Impella RP has been authorized 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.
    [Show full text]
  • ACMC Impella Guide
    ACMC Impella Guide Indications: acute heart failure, cardiogenic shock, acute and post myocardial infarctions, acute on chronic ischemic cardiomyopathy, myocarditis, cardiac transplant-related acute graft failure, support during PCI, etc. Contraindications: aortic regurgitation, severe aortic valve calcification, prosthetic aortic valves, aortic dissection, left ventricular thrombi, ventricular septal defects, severe sepsis, severe PAD, and bleeding diathesis. Insertion: Impella 2.5 and CP are inserted via the femoral artery, Impella 5.0 is inserted axillary or via femoral artery cut-down. Impella RP is inserted via the femoral vein. Complications: anemia, hemolysis, aortic injury and aortic valve insufficiency, arrhythmias, bleeding, cardiac tamponade, CVA, functional mitral stenosis, limb ischemia, mitral regurgitation secondary to chordal rupture. Device malfunction is predominantly due to device thrombosis (heparin should be in place). Power Sources: AC or internal battery. BATTERY HAS ONE HOUR OF LIFE! Keep plugged in!!! SUPPLIES NEEDED: *You will likely be taking the device from the sending facility and it will need to be returned. Take the device off of the wheeled stand and secure to rack-pack (do not block cooling vents). *If possible, take the manual for the device with you. It has a wealth of information regarding alarms/issues. Return it to sending facility when you return their device. *If possible, take an extra purge cassette with you (in case of leak/failure). If you don’t use it, you can return it to the sending facility when you return their device. Manual or rep can walk you through setting up a new purge cassette if needed. *PATIENT ASSESSMENT: *All pulses as normal – but check distal pulses from insertion site with each set of vitals.
    [Show full text]