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<TITLE>Filed by Bowne Pure Compliance</TITLE>
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<P style="font-size: 14pt" align="center"><B>UNITED STATES<BR>
SECURITIES AND
EXCHANGE COMMISSION<BR>
<FONT style="font-size: 12pt">Washington, D.C. 20549
</FONT></B>

<P style="font-size: 18pt" align="center"><B>FORM 8-K</B>

<P style="font-size: 12pt" align="center"><B>CURRENT REPORT<BR>
Pursuant to
Section 13 or 15(d) of the Securities Exchange Act of 1934</B>

<P style="font-size: 10pt" align="center"><B>Date of Report (Date of earliest
event reported): January 30, 2009</B>


<P style="font-size: 24pt" align="center"><B>HEARTWARE INTERNATIONAL,
INC.<BR>
</B><FONT style="font-size: 10pt">(Exact name of registrant as
specified in its charter) </FONT>
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  <TD width="32%">&nbsp;</TD>
  <TD width="1%">&nbsp;</TD>
  <TD width="33%">&nbsp;</TD>
  <TD width="1%">&nbsp;</TD>
  <TD width="32%">&nbsp;</TD>
 </TR>
 <TR valign="bottom">
  <TD style="border-bottom: #000000 1px solid"><B>Delaware</B></TD>
  <TD>&nbsp;</TD>
  <TD style="border-bottom: #000000 1px solid"><B>000-52595</B></TD>
  <TD>&nbsp;</TD>
  <TD style="border-bottom: #000000 1px solid"><B>26-3636023</B></TD>
 </TR>
 <TR valign="top">
  <TD>(State or other Jurisdiction of Incorporation)</TD>
  <TD>&nbsp;</TD>
  <TD>(Commission File Number)</TD>
  <TD>&nbsp;</TD>
  <TD>(IRS Employer Identification No.)</TD>
 </TR>

</TABLE>
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cellpadding="0" width="100%" border="0">

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  <TD width="49%">&nbsp;</TD>
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  <TD width="49%">&nbsp;</TD>
 </TR>
 <TR valign="bottom">
  <TD style="border-bottom: #000000 1px solid"><B>205 Newbury Street, Suite
101<BR>
Framingham, MA<BR>
</B></TD>
  <TD>&nbsp;</TD>
  <TD style="border-bottom: #000000 1px solid"><B>01701</B></TD>
 </TR>
 <TR valign="top">
  <TD>(Address of Principal Executive Offices)</TD>
  <TD>&nbsp;</TD>
  <TD>(Zip Code)</TD>
 </TR>

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<P style="font-size: 10pt" align="center">Registrant&#8217;s telephone number,
including area code: <B>508.739.0950</B>
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cellpadding="0" width="30%" border="0">

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  <TD style="border-bottom: #000000 1px solid" nowrap><B>&nbsp;</B></TD>
 </TR>
 <TR>
  <TD nowrap>(Former name or former address if changed since last report.)</TD>
 </TR>

</TABLE>


<P style="font-size: 10pt" align="left">Check the appropriate box below if the
Form 8-K filing is intended to simultaneously satisfy the filing obligation of
the registrant under any of the following provisions:

<P style="font-size: 10pt" align="left"><FONT face="Wingdings">o</FONT> Written
communications pursuant to Rule 425 under the Securities Act (17 CFR
230.425)<BR>
<BR>
<FONT face="Wingdings">o</FONT> Soliciting material pursuant
to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)<BR>
<BR>
<FONT
face="Wingdings">o</FONT> Pre-commencement communications pursuant to Rule
14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))<BR>
<BR>
<FONT
face="Wingdings">o</FONT> Pre-commencement communications pursuant to Rule
13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))<BR>


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<P style="font-size: 10pt" align="left"><B>Item&nbsp;7.01 Regulation&nbsp;FD
Disclosure</B>

<P style="font-size: 10pt" align="left">On January&nbsp;30, 2009 the Company
announced, via an Australian Securities Exchange (&#8220;ASX&#8221;)
announcement, that it has received Conformite Europeene (&#8220;CE&#8221;) Mark
approval for its HeartWare<SUP
style="font-size: 85%; vertical-align: text-top">&#174;</SUP> Ventricular
Assist System. The system features a miniaturized, full-output, implantable
heart pump designed to treat patients suffering from advanced heart failure.
Receipt of CE Mark enables HeartWare to initiate commercial sales of the system
throughout the European Union.

<P style="font-size: 10pt" align="left">As previously advised, HeartWare has
begun to establish the necessary infrastructure in Europe to drive a commercial
rollout of the system and to support new customers on the continent. HeartWare
will focus initially on its existing trial sites and will expand to key new
target hospitals over the ensuing months.

<P style="font-size: 10pt" align="left">A copy of the complete ASX announcement
is attached.

<P style="font-size: 10pt" align="left"><B>Item&nbsp;9.01 Financial Statements
and Exhibits</B>

<P style="font-size: 10pt" align="left">Exhibit&nbsp;99.1 HeartWare
International, Inc. ASX announcement, dated January&nbsp;30, 2009

<P style="font-size: 10pt" align="left"><B>SIGNATURES</B>

<P style="font-size: 10pt" align="left">Pursuant to the requirements of the
Securities Exchange Act of 1934, the registrant has duly caused this report to
be signed on its behalf by the undersigned hereunto duly authorized.
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  <TD valign="top">&nbsp;</TD>
  <TD>&nbsp;</TD>
  <TD valign="top" align="left" colspan="3">HeartWare International, Inc.</TD>
 </TR>
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  <TD valign="top">
<DIV style="margin-left: 0px; text-indent: 0px"><BR>Date: January&nbsp;30, 2009
</DIV>
</TD>
  <TD>&nbsp;</TD>
  <TD valign="top" align="left"><BR>By: </TD>
  <TD>&nbsp;</TD>
  <TD valign="top" align="left"><BR>/s/ David McIntyre</TD>
 </TR>
 <TR style="font-size: 1px">
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<DIV style="margin-left: 0px; text-indent: 0px">&nbsp;</DIV>
</TD>
  <TD>&nbsp;</TD>
  <TD valign="top" align="left">&nbsp;</TD>
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  <TD style="border-top: #000000 1px solid" valign="top"
align="left">&nbsp;</TD>
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</TD>
  <TD>&nbsp;</TD>
  <TD valign="top" align="left">&nbsp;</TD>
  <TD>&nbsp;</TD>
  <TD valign="top" align="left">Name: David McIntyre</TD>
 </TR>
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  <TD valign="top">
<DIV style="margin-left: 0px; text-indent: 0px">&nbsp;</DIV>
</TD>
  <TD>&nbsp;</TD>
  <TD valign="top" align="left">&nbsp;</TD>
  <TD>&nbsp;</TD>
  <TD valign="top" align="left">Title: Chief Financial Officer and Chief
Operating Officer</TD>
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<P style="font-size: 10pt" align="center">&nbsp;

<P style="display: none; font-size: 10pt" align="center">2
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{"company-data": {"conformed-name": "HeartWare International, Inc.", "cik": "0001389072", "assigned-sic": "3841", "irs-number": "980498958", "state-of-incorporation": "DE", "fiscal-year-end": "1231"}, "filing-values": {"form-type": "8-K", "act": "34", "file-number": "000-52595", "film-number": "09557228"}, "business-address": {"street1": "14000 NW 57TH COURT", "city": "MIAMI LAKES", "state": "FL", "zip": "33014", "phone": "508-739-0841"}, "mail-address": {"street1": "205 NEWBURY STREET", "street2": "SUITE 101", "city": "FRAMINGHAM", "state": "MA", "zip": "01701"}, "former-company": {"former-conformed-name": "HeartWare LTD", "date-changed": "20070206"}}
Filed by Bowne Pure Compliance
UNITED STATES
SECURITIES AND
EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 8-K
CURRENT REPORT
Pursuant to
Section 13 or 15(d) of the Securities Exchange Act of 1934
Date of Report (Date of earliest
event reported): January 30, 2009
HEARTWARE INTERNATIONAL,
INC.
(Exact name of registrant as
specified in its charter)
Delaware
000-52595
26-3636023
(State or other Jurisdiction of Incorporation)
(Commission File Number)
(IRS Employer Identification No.)
205 Newbury Street, Suite
101
Framingham, MA
01701
(Address of Principal Executive Offices)
(Zip Code)
Registrant's telephone number,
including area code:
508.739.0950
(Former name or former address if changed since last report.)
Check the appropriate box below if the
Form 8-K filing is intended to simultaneously satisfy the filing obligation of
the registrant under any of the following provisions:
o
Written
communications pursuant to Rule 425 under the Securities Act (17 CFR
230.425)
o
Soliciting material pursuant
to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)
o
Pre-commencement communications pursuant to Rule
14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))
o
Pre-commencement communications pursuant to Rule
13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))
Item 7.01 Regulation FD
Disclosure
On January 30, 2009 the Company
announced, via an Australian Securities Exchange ("ASX")
announcement, that it has received Conformite Europeene ("CE") Mark
approval for its HeartWare
®
Ventricular
Assist System. The system features a miniaturized, full-output, implantable
heart pump designed to treat patients suffering from advanced heart failure.
Receipt of CE Mark enables HeartWare to initiate commercial sales of the system
throughout the European Union.
As previously advised, HeartWare has
begun to establish the necessary infrastructure in Europe to drive a commercial
rollout of the system and to support new customers on the continent. HeartWare
will focus initially on its existing trial sites and will expand to key new
target hospitals over the ensuing months.
A copy of the complete ASX announcement
is attached.
Item 9.01 Financial Statements
and Exhibits
Exhibit 99.1 HeartWare
International, Inc. ASX announcement, dated January 30, 2009
SIGNATURES
Pursuant to the requirements of the
Securities Exchange Act of 1934, the registrant has duly caused this report to
be signed on its behalf by the undersigned hereunto duly authorized.
HeartWare International, Inc.
Date: January 30, 2009
By:
/s/ David McIntyre
Name: David McIntyre
Title: Chief Financial Officer and Chief
Operating Officer