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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 ................................. -
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. -
Heartmate II® LVAS LEFT VENTRICULAR ASSIST SYSTEM
HeartMate II® LVAS LEFT VENTRICULAR ASSIST SYSTEM OPERATING MANUAL Corporate Headquarters Authorized EU Representative Thoratec Corporation Thoratec Europe Limited 6035 Stoneridge Drive Burnett House, Lakeview Court Pleasanton, CA 94588 Ermine Business Park USA Huntingdon, Cambs PE29 6UA UK Business: Business: Tel.: 925-847-8600 Tel.: +44(0) 1480 455200 Fax: 925-847-8574 Fax: +44(0) 1480 454126 Emergencies: Urgent/24-Hour: 800-456-1477 (USA HeartLine™) +44(0) 7659 877901 925-847-8600 (International) www.thoratec.com 103884.C 12/2009 FOREWORD This manual contains information needed to properly and safely operate the Thoratec HeartMate II® Left Ventricular Assist System (LVAS). The Operating Manual and the Instructions for Use are intended to serve as both clinical textbook and reference; the new user should read both documents in their entirety, before system operation. For experienced practitioners, this manual may serve as a reference for detailed information. Users of the HeartMate II LVAS should have a practical knowledge of the principles of mechanical circulatory assist support (MSC) and should be aware of the physiological and psychological needs of a patient undergoing mechanical ventricular support. Sections 1-3 offer the reader an overall perspective of the system. They also describe the indications for use and the contraindications. Lastly, these sections introduce some of the unique attributes of the HeartMate II LVAS. Sections 4-11 explain how the system works, describe the technical features and operation of each system component and include descriptions of a variety of situations likely to arise during and after pump implantation. Sections 12-13 describe in detail the procedures necessary to support HeartMate II LVAS patients, including equipment cleaning and maintenance requirements. -
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. -
Instructions for Use
Instructions for Use Featuring the Mobile Power Unit Thoratec Corporation HEARTMATE II® LEFT VENTRICULAR ASSIST SYSTEM Instructions for Use United States & Canada Thoratec Corporation (International Headquarters) 6035 Stoneridge Drive Pleasanton, CA 94588 USA Telephone: (925) 847-8600 Fax: (925) 847-8574 Emergency HeartLine™ USA: (800) 456-1477 Emergencies outside USA: (925) 847-8600 Authorized EU Representative European Authorized Representative: St. Jude Medical Coordination Center BVBA The Corporate Village Da Vincilaan 11 Box F1 1935 Zaventem Belgium +32 2 774 68 11 Website: www.thoratec.com Thoratec Corporation continually strives to provide the highest quality of products for mechanical circulatory support. Specifications may change without notice. HeartMate II, Thoratec, and the Thoratec logo are registered trademarks, and HeartLine is a trademark of Thoratec Corporation. ©2016 Thoratec Corporation. Document: 10006961.B Publication Date: 03/2019 HeartMate II Left Ventricular Assist System Instructions for Use iii Contents Preface- - - - - - - - - - - - - - - - - - - - - - - ix 1 Introduction - - - - - - - - - - - - - - - - - - - - 1-1 Understanding Warnings and Cautions - - - - - - - - - - - - - - - - - - - - 1-3 Overview - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 1-4 Indications - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 1-6 Contraindications - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 1-6 Adverse Events - - - - - - - - - - - - - - - - - - - - - - - - - - - -
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. -
Thoratec Corporation
· UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549-4561 January 27,2012 Charles K. Ruck Latham & Watkins LLP [email protected] Re: Thoratec Corporation Dear Mr. Ruck: This is in regard to your letter dated January 25,2012 concerning the shareholder proposal submitted by Oracle Partners, LP for inclusion in Thoratec's proxy materials for its upcoming annual meeting of security holders. Your letter indicates that the proponent has withdrawn the proposal and that Thoratec therefore withdraws its January 17,2012 request for a no-action letter from the Division. Because the matter is now moot, we will have no further comment. Copies ofall ofthe correspondence related to this matter will be made available on our website at http://www.sec.gov/divisions/corpfinlcf-noactionl14a-S.shtml. For your reference, a brief discussion ofthe Division's informal procedures regarding shareholder proposals is also available at the same website address. Sincerely, Charles K won Special Counsel cc: LarryN. Feinberg Managing Member Oracle Associates, LLC 200 Greenwich Avenue Greenwich, CT 06830 650 Town Center Drive. 20th Floor Costa Mesa. California 92626-1925 Tel:·+1.714.540.1235 Fax: +1.714.755.8290 www.lw.com FIRM I AFFILIATE OFFICES NSLLP LATHAM&WATKI Abu Dhabi Moscow Barcelona Munich Beijing New Jersey Boston New York Brussels Orange County Chicago Paris Doha Riyadh Dubai Rome Frankfurt San Diego January 25, 2012 Hamburg San Francisco Hong Kong Shanghai Houston Silicon Valley London Singapore Los Angeles Tokyo VL4EMAIL Madrid washington. D.C. Milan U.S. Securities and Exchange Commission Division ofCorporation Finance Office of Chief Counsel 100 F Street, N.E. -
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 -
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Case3:14-cv-00360 Document1 Filed01/24/14 Page1 of 36 LIONEL Z. GLANCY (#134180) 1 MICHAEL GOLDBERG (#188669) 2 ROBERT V. PRONGAY (#270796) GLANCY BINKOW & GOLDBERG LLP 3 1925 Century Park East, Suite 2100 Los Angeles, California 90067 4 Telephone: (310) 201-9150 5 Facsimile: (310) 201-9160 E-mail: [email protected] 6 [email protected] [email protected] 7 [email protected] 8 Attorneys for Plaintiff 9 [Additional Counsel on Signature Page] 10 11 UNITED STATES DISTRICT COURT NORTHERN DISTRICT OF CALIFORNIA 12 BRADLEY COOPER, Individually and On ) Case No. 13 Behalf of All Others Similarly Situated, ) 14 ) CLASS ACTION P l a i n t i f f s , ) 15 ) COMPLAINT FOR VIOLATIONS v. ) OF FEDERAL SECURITIES 16 ) LAWS THORATEC CORPORATION, GERHARD F. 17 ) BURBACH, TAYLOR C. HARRIS, and ) DEMAND FOR JURY TRIAL 18 ROXANNE OULMAN, ) ) 19 Defendants. ) 20 21 22 23 24 25 26 27 28 Case3:14-cv-00360 Document1 Filed01/24/14 Page2 of 36 CLASS ACTION COMPLAINT 1 2 Plaintiff Bradley Cooper (“Plaintiff”), individually and on behalf of all other persons similarly 3 situated, by his undersigned attorneys, for his complaint against defendants, alleges the following based 4 upon personal knowledge as to himself and his own acts, and information and belief as to all other 5 matters, based upon, inter alia, the investigation conducted by and through his attorneys, which 6 included, among other things, a review of the defendants’ public documents, conference calls and 7 announcements made by defendants, United States Securities and Exchange Commission (“SEC”) 8 9 filings, wire and press releases published by and regarding Thoratec Corporation (“Thoratec” or the 10 “Company”), analysts’ reports and advisories about the Company, and information readily obtainable 11 on the Internet. -
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. -
Risk Assessment and Comparative Effectiveness of Left Ventricular
JACC: HEART FAILURE VOL. - ,NO.- ,2017 ª 2017 BY THE AMERICAN COLLEGE OF CARDIOLOGY FOUNDATION ISSN 2213-1779/$36.00 PUBLISHED BY ELSEVIER http://dx.doi.org/10.1016/j.jchf.2017.02.016 Risk Assessment and Comparative Effectiveness of Left Ventricular Assist Device and Medical Management in Ambulatory Heart Failure Patients The ROADMAP Study 2-Year Results Randall C. Starling, MD, MPH,a Jerry D. Estep, MD,b Douglas A. Horstmanshof, MD,c Carmelo A. Milano, MD,d Josef Stehlik, MD, MPH,e Keyur B. Shah, MD,f Brian A. Bruckner, MD,b Sangjin Lee, MS, MD,g c e f h James W. Long, MD, PHD, Craig H. Selzman, MD, Vigneshwar Kasirajan, MD, Donald C. Haas, MD, i j j d Andrew J. Boyle, MD, Joyce Chuang, PHD, David J. Farrar, PHD, Joseph G. Rogers, MD, for the ROADMAP Study Investigators ABSTRACT OBJECTIVES The authors sought to provide the pre-specified primary endpoint of the ROADMAP (Risk Assessment and Comparative Effectiveness of Left Ventricular Assist Device and Medical Management in Ambulatory Heart Failure Patients) trial at 2 years. BACKGROUND The ROADMAP trial was a prospective nonrandomized observational study of 200 patients (97 with a left ventricular assist device [LVAD], 103 on optimal medical management [OMM]) that showed that survival with improved functional status at 1 year was better with LVADs compared with OMM in a patient population of ambulatory New York Heart Association functional class IIIb/IV patients. METHODS The primary composite endpoint was survival on original therapy with improvement in 6-min walk distance $75 m. RESULTS Patients receiving LVAD versus OMM had lower baseline health-related quality of life, reduced Seattle Heart Failure Model 1-year survival (78% vs. -
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