1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20

Total Page:16

File Type:pdf, Size:1020Kb

1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 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. 12 NATURE OF THE ACTION 13 1. This is a federal securities class action on behalf of a class consisting of all persons other 14 15 than defendants who purchased Thoratec securities between April 29, 2010 and November 27, 2013, 16 inclusive (the “Class Period”), seeking to recover damages caused by defendants’ violations of the 17 federal securities laws and to pursue remedies under the Securities Exchange Act of 1934 (the 18 “Exchange Act”). 19 2. Thoratec researches, develops, manufactures, and markets medical devices for circulatory 20 21 support and vascular graft applications. The Company’s products include a ventricular assist device, an 22 implantable left ventricular heart assist device, a vascular access graft, and a coronary artery bypass 23 graft. Thoratec also supplies whole-blood coagulation testing equipment. 24 3. Throughout the Class Period, Defendants failed to disclose that the Company’s HeartMate 25 II Left Ventricular Assist Device had significant risk of pump thrombosis, causing numerous fatalities. 26 As a result of the foregoing, the Company’s statements were materially false and misleading at all 27 28 relevant times. COMPLAINT 1 Case3:14-cv-00360 Document1 Filed01/24/14 Page3 of 36 4. The truth slowly emerged over several months, that the Company’s products were in fact 1 2 not as safe as conveyed to investors and the medical community, and in fact caused severed adverse 3 events such as blood clots. 4 5. On April 4, 2012, U.S. regulators ordered a recall for the company’s HeartMate II heart 5 pumps for a potentially deadly defect. In a regulatory posting by the Food and Drug Administration, the 6 agency stated that the recall “was initiated after Thoratec found that a component of the implanted 7 8 device, which pumps blood for heart failure patients, may sometimes be improperly attached to the 9 HeartMate II.” 10 6. In a note to investors, analyst Steven Lichtman, at Oppenheimer & Co in New York wrote 11 that, “the positioning of the component, called a bend relief, has been a concern tied to an increase in 12 blood clots seen with HeartMate II.” 13 14 7. On the news, shares of Thoratec shares tumbled $1.52 or almost 4.5% to close at $32.83 15 on volume of 5,441,400 shares. 16 8. Then, on November 27, 2013, after the market closed, The New England Journal of 17 Medicine released a study entitled, “Unexpected Abrupt Increase in Left Ventricular Assist Device 18 Thrombosis” concluding that the “rate of pump thrombosis related to the use of the HeartMate II has 19 been increasing at our centers and is associated with substantial morbidity and mortality.” 20 21 9. On this news, Thoratec shares declined $2.75 per share or 6.5%, to close at $39.37 per 22 share on November 29, 2013. 23 10. As a result of Defendants’ wrongful acts and omissions, and the precipitous decline in the 24 market value of the Company’s securities, Plaintiff and other Class members have suffered significant 25 damages. 26 27 28 COMPLAINT 2 Case3:14-cv-00360 Document1 Filed01/24/14 Page4 of 36 JURISDICTION AND VENUE 1 2 11. The claims asserted herein arise under and pursuant to Sections l0(b) and 20(a) of the 3 Exchange Act, 15 U.S.C. §§ 78j(b) and 78t(a), and Rule l0b-5 promulgated thereunder by the SEC, 17 4 C.F.R § 240.10b-5. 5 12. This Court has jurisdiction over the subject matter of this action pursuant to 28 U.S.C. §§ 6 1331 and 1337, and Section 27 of the Exchange Act, 15 U.S.C. § 78aa. 7 13. Venue is proper in this District pursuant to Section 27 of the Exchange Act, and 28 U.S.C. 8 9 § 1391(b). Thoratec maintains its principal place of business in this District and many of the acts and 10 practices complained of occurred in substantial part herein. 11 14. In connection with the acts alleged in this complaint, Defendants, directly or indirectly, 12 used the means and instrumentalities of interstate commerce, including, but not limited to, the mails, 13 interstate telephone communications, and the facilities of the national securities markets. 14 15 PARTIES 16 15. Plaintiff, as set forth in the accompanying certification, incorporated by reference herein, 17 purchased Thoratec securities at artificially inflated prices during the Class Period and was damaged by 18 the revelation of the alleged corrective disclosures. 19 16. Defendant Thoratec is a California corporation with its principal place of business at 6035 20 21 Stoneridge Drive, Pleasanton, CA 94588. Thoratec’s common stock trades on the NASDAQ Global 22 Market (“NASDAQ”) under the ticker symbol “THOR.” 23 17. Defendant Gerhard F. Burbach (“Burbach”) has served at all relevant times as the 24 Company’s President and Chief Executive Officer. 25 18. Defendant Taylor C. Harris (“Harris”) has served at all relevant times as the Company’s 26 Chief Financial Officer and Vice President since October 11, 2012. 27 28 COMPLAINT 3 Case3:14-cv-00360 Document1 Filed01/24/14 Page5 of 36 19. Defendant Roxanne Oulman (“Oulman”) has served at all relevant times as the Company’s 1 2 Vice President of Finance, served as the Company’s interim Chief Financial Officer between June 2011 3 and October 2012. 4 20. The defendants referenced above in ¶¶ 13 - 15 are referred to herein as the “Individual 5 Defendants.” 6 SUBSTANTIVE ALLEGATIONS 7 BACKGROUND 8 9 21. Thoratec is a world leader in mechanical support with a product portfolio to treat the full 10 range of clinical needs for advanced heart failure patients. The Company develops, manufactures and 11 markets proprietary medical devices used for mechanical circulatory support (“MCS”) for the treatment 12 of heart failure (“HF”) patients. For chronic circulatory support for HF patients, the Company’s 13 primary product lines are its ventricular assist devices include HeartMate Left Ventricular Assist 14 15 System and HeartMate II Left Ventricular Assist System (“HeartMate II”). 16 22. HeartMate II is an implantable, electrically powered, continuous flow, left ventricular 17 assist device consisting of a rotary blood pump designed to provide intermediate and long-term MCS. 18 HeartMate II is designed to improve survival and quality of life for a broad range of advanced HF 19 patients. HeartMate II received Food and Drug Administration (“FDA”) approval in April 2008 for 20 21 bridge-to-transplantation (“BTT”) and received FDA approval for use in HF patients who are not 22 eligible for heart transplantation in January 2010. 23 MATERIALLY FALSE AND MISLEADING STATEMENTS MADE DURING THE CLASS PERIOD 24 25 23. On April 29, 2010, the Company issued a press release reporting financial results for the 26 first quarter ended April 3, 2010. Specifically, the Company reported net income of $12.4 million, or 27 $0.21 diluted EPS and sales of $121.6 million, as compared to net income of $5.6 million, or $0.10 28 diluted EPS and sales of $89.5 million for the same period a year ago. COMPLAINT 4 Case3:14-cv-00360 Document1 Filed01/24/14 Page6 of 36 24. In the press release, the Company stated the following in relevant part: 1 2 “Thoratec had an excellent start to 2010 as we initiated the commercial launch of our HeartMate II LVAS (Left Ventricular Assist System) for Destination Therapy (DT) 3 following the receipt of FDA approval of our PreMarket Application (PMA) Supplement in January,” noted Gary F. Burbach, president and chief executive officer. 4 5 “Our DT launch initiatives have enabled us to achieve rapid traction in the market. Our financial performance in the quarter reflects not only the benefit of initial DT 6 commercial activity in the U.S., but also continued adoption of the HeartMate II in Europe and our new HeartMate external peripherals introduced last fall.
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]
  • 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.
    [Show full text]
  • 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 - - - - - - - - - - - - - - - - - - - - - - - - - - -
    [Show full text]
  • 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.
    [Show full text]
  • 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.
    [Show full text]
  • Cardiac Assist Devices
    Cardiac Assist Devices Current and Pipeline Products GDME1006FPR / Published March 2013 Table of Contents 1 Table of Contents 1 Table of Contents ............................................................................................................... 2 1.1 List of Tables ............................................................................................................... 7 1.2 List of Figures ........................................................................................................... 13 2 Introduction ....................................................................................................................... 14 2.1 Catalyst ..................................................................................................................... 14 3 Competitive Assessment ................................................................................................... 16 3.1 Cardiac Assist Device Market, Comparison of Key Marketed Products ...................... 16 3.2 Ventricular Assist Devices Market, Key Company Share ............................................ 18 3.3 Ventricular Assist Devices, Comparison based on Pump Technology ........................ 19 3.4 Ventricular Assist Devices ......................................................................................... 20 3.4.1 Overview............................................................................................................. 20 3.4.2 First-Generation Devices ....................................................................................
    [Show full text]
  • IMACS Implant Printable Form
    Implant Device Information Additional indication for VAD: Failure to wean from CPB Post Cardiac Surgery None Enter cardiac operation: Device Type: LVAD RVAD Both (in the same OR visit) Total Artificial Heart Implant Date: Device Type (LVAD) Device Brand: Berlin Heart EXCOR Adult Berlin Heart EXCOR Pediatric Berlin Heart INCOR Circulite Synergy EvaHeart LVAS Heartmate II LVAS Heartmate IP Heartmate VE Heartmate XVE Heartware HVAD Jarvik 2000 Levacor LVAD Medos VAD Micromed Debakey VAD – Child Micromed HeartAssist 5 Novacor PC Novacor PCq Terumo Duraheart Thoratec IVAD Thoratec PVAD Device Type (RVAD) Device Brand: Berlin Heart EXCOR Adult Berlin Heart EXCOR Pediatric Berlin Heart INCOR Heartware HVAD Jarvik 2000 Medos VAD Thoratec IVAD Thoratec PVAD 1 of 3 Device Type – Total Artificial Heart Device Brand: SynCardia CardioWest AbioCor TAH Associated Findings (Surgical PFO/ASD observations or Intraoperative TEE): Aortic Insufficiency Tricuspid Insufficiency None Aortic Insufficiency: Mild Moderate Severe Tricuspid Insufficiency: Mild Moderate Severe Antibiotic Prophylaxis at time of Yes implant: No Unknown If yes, Select antibiotics/antifungals Amikacin days: ____________ given as prophylaxis at the Amphotericin days: ____________ time of Implant: Anidulafungin days: ____________ Aztreonam days: ____________ Caspafungin days: ____________ Cefazolin days: ____________ Cefuroxime days: ____________ Ceftazidime days: ____________ Ceftriaxone days: ____________ Cefepime days: ____________
    [Show full text]
  • Results of a Multicenter Clinical Trial with the Thoratec Implantable Ventricular Assist Device*
    View metadata, citation and similar papers at core.ac.uk brought to you by CORE Slaughter et al Cardiopulmonary Support and Physiology provided by Elsevier - Publisher Connector Results of a multicenter clinical trial with the Thoratec Implantable Ventricular Assist Device* Mark S. Slaughter, MD,a Steven S. Tsui, MD,b Aly El-Banayosy, MD,c Benjamin C. Sun, MD,d Robert L. Kormos, MD,e Dale K. Mueller, MD,f H. Todd Massey, MD,g Timothy B. Icenogle, MD,h David J. Farrar, PhD,i and J. Donald Hill, MD,j on behalf of the IVAD Study Group Objective: The Thoratec Implantable Ventricular Assist Device (Thoratec Corpo- Supplemental material is ration, Pleasanton, Calif) can be used for univentricular or biventricular support in available online. patients with a body surface area as low as 1.3 m2. Results of the multicenter clinical trial are reviewed. Methods: Between October 2001 and June 2004, a total of 39 patients at 12 institutions were supported with the Thoratec Implantable Ventricular Assist De- vice. Twenty-four patients (62%) received left ventricular assist devices and 15 (38%) received biventricular assist devices. Indications included bridge to trans- plantation (n ϭ 30) and postcardiotomy failure (n ϭ 9). The control group included 100 patients from the Food and Drug Administration approval submissions for the paracorporeal version of the ventricular assist device. From Advocate Christ Medical Center, Oak Results: Twenty-eight male and 11 female patients, with mean age of 48 years a Lawn, Ill ; Papworth Hospital, Cambridge, (16–71 years) and body surface area of 1.9 m2 (1.3–2.4 m2) were supported for 3938 UKb; Heart Center NRW, Bad Oeynhausen, Germanyc; Ohio State University, Colum- patient-days (10.8 patient-years).
    [Show full text]
  • Thoratec® Because There Are More Than Two Sides to the Story THORATEC CORPORATION
    Products & Technology Thoratec® Because there are more than two sides to the story THORATEC CORPORATION THORATEC LABORATORIES AND THERMO CARDIOSYSTEMS HAVE MERGED TO CREATE A NEW COMPANY OFFERING SURGEONS, CARDIOLOGISTS AND HOSPITALS THE WIDEST RANGE OF CIRCULATORY SUPPORT SOLUTIONS AVAILABLE FOR THE TREATMENT OF CONGESTIVE HEART FAILURE. Table of Contents Introduction ...............................................1 More Ways to Manage CHF..........................2 HeartMate® LVAS ........................................4 Thoratec® VAD System ................................6 Thoratec Vascular Graft Products .................8 Support and Technology Resources ............10 ITC Products ............................................12 We offer the widest range of circulatory support solutions. More than a Cardiac Assist Company Cardiovascular diseases are the world’s leading cause of death. One of the most prevalent is Congestive Heart Failure (CHF). In the U.S. alone, an estimated five million people suffer from CHF, with another half-million or more diagnosed each year. The five-year mortality rate is estimated at 50 percent. Thoratec is committed to lowering that figure. In that effort, we provide two complementary cardiac assist product lines—the Thoratec Ventricular Assist Device (VAD) System for short-term cardiac support and the HeartMate Left Ventricular Assist System (LVAS) for longer-term support. Together, these products address more indications than the products of any other cardiac assist device company. Our cardiac assist products, along with our unique family of vascular grafts, our ITC blood coagulation measurement products, and a large and growing pipeline of next-genera- tion devices in clinical trials or under development, make Thoratec a central resource for treatment offerings for cardiac surgeons, cardiologists and their patients. More Ways to Manage CHF More than short-term heart failure assistance.
    [Show full text]
  • Bradley Cooper, Et Al. V. Thoratec Corporation, Et Al. 14-CV-00360
    Case4:14-cv-00360-CW Document28 Filed06/20/14 Page1 of 67 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 Liaison Counsel for Lead Plaintiff and the Class 7 8 Jeremy A. Lieberman Patrick V. Dahlstrom POMERANTZ LLP Leigh Handelman Smollar 600 Third Avenue, 20th Floor Mark Bryan Goldstein New York, New York 10016 POMERANTZ LLP Telephone: (212) 661-1100 Ten South La Salle Street, Suite 3505 11 Facsimile: (212) 661-8665 Chicago, Illinois 60603 12 Telephone: (312) 377-1181 Facsimile: (312) 377-1184 [email protected] [email protected] [email protected] Counsel for Lead Plaintiff and the Class UNITED STATES DISTRICT COURT NORTHERN DISTRICT OF CALIFORNIA OAKLAND DIVISION BRADLEY COOPER, Individually and On Case No. 4:14-cv-00360-CW Behalf of All Others Similarly Situated, CLASS ACTION Plaintiffs, AMENDED CLASS ACTION v. COMPLAINT FOR VIOLATIONS OF THE FEDERAL SECURITIES LAWS THORATEC CORPORATION, GERHARD F. BURBACH, TAYLOR C. HARRIS, and DEMAND FOR JURY TRIAL ROXANNE OULMAN, Defendants Case4:14-cv-00360-CW Document28 Filed06/20/14 Page2 of 67 Lead Plaintiff Bradley Cooper (“Plaintiff”), individually and on behalf of all others similarly 1 2 situated, by his undersigned attorneys, for the Amended Complaint against Defendants Thoratec 3 Corporation (“Thoratec” or the “Company”), Gerhard F. Burbach (“Burbach”), Taylor C.
    [Show full text]
  • Current State-Of-The-Art of Device Therapy for Advanced Heart Failure
    View metadata, citation and similar papers at core.ac.uk brought to you by CORE provided by Harvard University - DASH Current state-of-the-art of device therapy for advanced heart failure The Harvard community has made this article openly available. Please share how this access benefits you. Your story matters. Citation Lee, Lawrence S., and Prem S. Shekar. 2014. “Current state-of- the-art of device therapy for advanced heart failure.” Croatian Medical Journal 55 (6): 577-586. doi:10.3325/cmj.2014.55.577. http://dx.doi.org/10.3325/cmj.2014.55.577. Published Version doi:10.3325/cmj.2014.55.577 Accessed February 17, 2015 11:31:15 AM EST Citable Link http://nrs.harvard.edu/urn-3:HUL.InstRepos:13890710 Terms of Use This article was downloaded from Harvard University's DASH repository, and is made available under the terms and conditions applicable to Other Posted Material, as set forth at http://nrs.harvard.edu/urn-3:HUL.InstRepos:dash.current.terms- of-use#LAA (Article begins on next page) ADVANCED HEART FAILURE 577 Croat Med J. 2014;55:577-86 doi: 10.3325/cmj.2014.55.577 Current state-of-the-art of Lawrence S. Lee, Prem S. Shekar device therapy for advanced Division of Cardiac Surgery, Brigham and Women’s Hospital, heart failure Harvard Medical School, Boston, MA, USA Heart failure remains one of the most common causes of morbidity and mortality worldwide. The advent of me- chanical circulatory support devices has allowed signifi- cant improvements in patient survival and quality of life for those with advanced or end-stage heart failure.
    [Show full text]
  • Total Artificial Hearts and Implantable Ventricular Assist Devices
    Name of Blue Advantage Policy: Total Artificial Hearts and Implantable Ventricular Assist Devices Policy #: 033 Latest Review Date: September 2020 Category: Surgery Policy Grade: A BACKGROUND: Blue Advantage medical policy does not conflict with Local Coverage Determinations (LCDs), Local Medical Review Policies (LMRPs) or National Coverage Determinations (NCDs) or with coverage provisions in Medicare manuals, instructions or operational policy letters. In order to be covered by Blue Advantage the service shall be reasonable and necessary under Title XVIII of the Social Security Act, Section 1862(a)(1)(A). The service is considered reasonable and necessary if it is determined that the service is: 1. Safe and effective; 2. Not experimental or investigational*; 3. Appropriate, including duration and frequency that is considered appropriate for the service, in terms of whether it is: • Furnished in accordance with accepted standards of medical practice for the diagnosis or treatment of the patient’s condition or to improve the function of a malformed body member; • Furnished in a setting appropriate to the patient’s medical needs and condition; • Ordered and furnished by qualified personnel; • One that meets, but does not exceed, the patient’s medical need; and • At least as beneficial as an existing and available medically appropriate alternative. *Routine costs of qualifying clinical trial services with dates of service on or after September 19, 2000 which meet the requirements of the Clinical Trials NCD are considered reasonable and necessary by Medicare. Providers should bill Original Medicare for covered services that are related to clinical trials that meet Medicare requirements (Refer to Medicare National Coverage Determinations Manual, Chapter 1, Section 310 and Medicare Claims Processing Manual Chapter 32, Sections 69.0-69.11).
    [Show full text]