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-----BEGIN PRIVACY-ENHANCED MESSAGE-----Proc-Type: 2001,MIC-CLEAROriginator-Name: [email protected]: MFgwCgYEVQgBAQICAf8DSgAwRwJAW2sNKK9AVtBzYZmr6aGjlWyK3XmZv3dTINen TWSM7vrzLADbmYQaionwg5sDW3P6oaM5D3tdezXMm7z1T+B+twIDAQABMIC-Info: RSA-MD5,RSA, N7O0j90Ut2SrI4bvT204ofOP0+Q3F98j+rhe5ksfuWJgxbAZOzXAF3OOpY9r3nn5 ZXfyyhuUO1MtVp0hsgf2Sg==

0000950123-10-105260.txt : 201011150000950123-10-105260.hdr.sgml : 2010111520101115060451ACCESSION NUMBER:0000950123-10-105260CONFORMED SUBMISSION TYPE:8-KPUBLIC DOCUMENT COUNT:21CONFORMED PERIOD OF REPORT:20101114ITEM INFORMATION:Regulation FD DisclosureITEM INFORMATION:Other EventsITEM INFORMATION:Financial Statements and ExhibitsFILED AS OF DATE:20101115DATE AS OF CHANGE:20101115

FILER:

COMPANY DATA:COMPANY CONFORMED NAME:HeartWare International, Inc.CENTRAL INDEX KEY:0001389072STANDARD INDUSTRIAL CLASSIFICATION:SURGICAL & MEDICAL INSTRUMENTS & APPARATUS [3841]IRS NUMBER:980498958STATE OF INCORPORATION:DEFISCAL YEAR END:1231

FILING VALUES:FORM TYPE:8-KSEC ACT:1934 ActSEC FILE NUMBER:001-34256FILM NUMBER:101189044

BUSINESS ADDRESS:STREET 1:14000 NW 57TH COURTCITY:MIAMI LAKESSTATE:FLZIP:33014BUSINESS PHONE:508-739-0841

MAIL ADDRESS:STREET 1:205 NEWBURY STREETSTREET 2:SUITE 101CITY:FRAMINGHAMSTATE:MAZIP:01701

FORMER COMPANY:FORMER CONFORMED NAME:HeartWare LTDDATE OF NAME CHANGE:20070206

8-K1c08522e8vk.htmFORM 8-K

Form 8-K

UNITED STATES
SECURITIES ANDEXCHANGE COMMISSION
Washington, D.C. 20549

FORM 8-K

CURRENT REPORT
Pursuant toSection 13 or 15(d) of the Securities Exchange Act of 1934

Date of Report (Date of earliestevent reported): November 14, 2010

HEARTWARE INTERNATIONAL,INC.
(Exact name of registrant asspecified in its charter)

Delaware 001-34256 26-3636023 (State or other Jurisdiction of Incorporation) (Commission File Number) (IRS Employer Identification No.)

205 Newbury Street, Suite101
Framingham, MA
01701 (Address of Principal Executive Offices) (Zip Code)

Registrants telephone number,including area code: 508.739.0950

(Former name or former address if changed since last report.)

Check the appropriate box below if theForm 8-K filing is intended to simultaneously satisfy the filing obligation ofthe registrant under any of the following provisions:

o Writtencommunications pursuant to Rule 425 under the Securities Act (17 CFR230.425)

o Soliciting material pursuantto Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)

o Pre-commencement communications pursuant to Rule14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))

o Pre-commencement communications pursuant to Rule13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

1

Item7.01 RegulationFDDisclosure

Exhibit99.1 attached hereto isthe slide presentation used by Keith Aaronson, MD, MS, when he presented datafrom our ADVANCE Bridge-to-Transplant clinical trial on Sunday,November14, at the American Heart Association (AHA)ScientificSessions 2010 at McCormick Place in Chicago. Dr.Aaronson, AssociateProfessor in the Division of Cardiovascular Medicine and Medical Director ofthe Heart Transplant Program and Center for Circulatory Support at theUniversity of Michigan, is a principal investigator of the ADVANCE trial. Theviews expressed in these slides by Dr.Aaronson are his individual viewsand not necessarily those of the company.

The information in this Item7.01to Current Report on Form 8-K and the Exhibit99.1 attached hereto shallnot be deemed filed for purposes of Section18 of theSecurities Exchange Act of 1934 (the Exchange Act) or otherwisesubject to the liabilities of that section, nor shall it be deemed incorporatedby reference in any filing under the Securities Act of 1933 or the ExchangeAct, regardless of any general incorporation language in such filing.

Item8.01 Other Events

HeartWare International, Inc.released apress release announcing the presentation of data from its U.S. ADVANCEBridge-to-Transplant clinical trial.

A copy of the press release is attachedhereto as Exhibit99.2 and is incorporated herein by reference.

Item9.01 Financial Statementsand Exhibits

Exhibit99.1 Slide Presentation ofDr.Keith Aaronson dated November14, 2010
Exhibit99.2HeartWare International, Inc. press release dated November14, 2010

2

SIGNATURES

Pursuant to the requirements of theSecurities Exchange Act of 1934, the registrant has duly caused this report tobe signed on its behalf by the undersigned hereunto duly authorized.

HeartWare International, Inc.
Date: November15, 2010


By:
/s/ David McIntyre

Name: David McIntyre

Title: Chief Operating Officer
& ChiefFinancial Officer

3

EX-99.12c08522exv99w1.htmEXHIBIT 99.1

Exhibit 99.1

Exhibit 99.1

Keith Aaronson, Mark Slaughter, Edwin McGee,William Cotts, Michael Acker, Mariell Jessup,Igor Gregoric, Pranav Loyalka, Valluvan Jeevanandam,Allen Anderson, Robert Kormos, Jeffrey Teuteberg,Francis Pagani, Steven Boyce, David Hathaway,Leslie Miller for the HeartWare ADVANCE Investigators

Evaluation of the HeartWare HVAD LeftVentricular Assist System for theTreatment of Advanced Heart Failure:Results of the ADVANCE Bridge toTransplant Trial

American Heart Association Scientific Sessions 2010

Presenter Disclosure Information

Keith Aaronson, MD, MSFINANCIAL DISCLOSUREResearch Support: HeartWare*, Thoratec*, TerumoClinical Steering Committee: HeartWarePersonal remuneration: none* My activities with HeartWare and Thoratec have beenreviewed and approved by the University of MichiganMedical School Conflict of Interest Board and a managementplan is in place.UNLABELED/UNAPPROVED USES DISCLOSUREI will discuss investigational use of the HeartWare HVAD

HeartWare Ventricular Assist System

HVAD miniaturized implantable blood pumpPericardial placement - no pump pocketProvides up to 10 L/min of flowCentrifugal design, continuous flowHybrid magnetic / hydrodynamic impellersuspensionOptimizes flow, pump surface washing, andhemocompatibilityThin (4.2 mm), flexible driveline with fatigueresistant cables

Multi-site (30), prospective trial to evaluate the HeartWare HVADas a bridge-to-transplant in the USEnrollment period was August 2008 to February 2010All patients were followed for ^ 180 days following implant or untilearlier cardiac transplantation, device explant for recovery or deathTreatment group was compared to a contemporaneous controlgroup consisting of patients enrolled in the Interagency Registry forMechanically Assisted Circulatory Support (INTERMACS) whoreceived a commercially-available, durable, left ventricular assistdevice as a BTT

ADVANCE Trial Design

Adult patients who received a primary LVADas a BTT during the enrollment periodListed for transplant at time of implantBSA ^ 1.2m2Serum creatinine ^ 5 without dialysisNot on ventilatorFirst VADIABP only allowable preop circulatorysupport

Treatment Group (n=137)

Inclusion Criteria: age >18 years,BSA >1.2m2, NYHA Class IV, listedUNOS Status 1A or 1BStandard LVAD/transplant exclusioncriteriaIABP only allowable preop circulatorysupport

INTERMACS Control (n=499)

* 2 excluded for liver enzymes >3x normal, 1 excluded for participation in another trial

Derivation of Treatment & Control Populations

Patients excluded whodid not meetcriteria for primaryanalysis cohort

- - Screen failures (17)

= Intent to Treat (140)

- - 3 patients*

= Per Protocol Pop.

Primary OutcomeSuccess*, defined as survival on the originally implanted device,transplant or explant for ventricular recovery (must survive 60 days post-explant) at 180 daysAnalysis adjusted by propensity scorePredictors: age, gender, BUN, creatinine, BSA, right atrial pressure,prior sternotomy, INTERMACS profile

Secondary OutcomesComparison of survival between treatment and control groupsFunctional and QoL outcomes and AEs in the treatment groupFunctional status changes, measured by 6-min walk testQoL changes, measured by KCCQ and EuroQoL EQ-5DIncidence of SAEs

* Per Protocol cohort

ADVANCE Trial: Analyses

Control(n=499) P value 52.2 +- 12.2 0.19 120 (24%) 0.36 2.07 +- 0.3 0.59 28.9 +- 20.9 0.94 11.5 +- 5.0 0.53 1.4 +- 0.6 0.89

ADVANCE Trial: Baseline Characteristics

PropensityScore

INTERMACSPatient Profile

* Safety Population (N=140) for INTERMACS Patient Profile;Per Protocol Population (N=137) for Propensity Score

INTERMACS & Propensity Score

Control Group Success: 90.1%Treatment Group Success: 92.0%Difference: -1.9%95% Upper Confidence Limit (UCL) on difference 0.9%

Principal Analysis: Noninferiority The UCL, 0.9%, is less than the prespecified 15% noninferioritymargin. Treatment group success is noninferior to control 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