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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): December 4, 2008</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 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>
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  <TD style="border-bottom: #000000 1px solid"><B>205 Newbury Street<BR>
Framingham, MA<BR>
</B></TD>
  <TD>&nbsp;</TD>
  <TD style="border-bottom: #000000 1px solid"><B>01701</B></TD>
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  <TD>(Address of Principal Executive Offices)</TD>
  <TD>&nbsp;</TD>
  <TD>(Zip Code)</TD>
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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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  <TD style="border-bottom: #000000 1px solid" nowrap><B>&nbsp;</B></TD>
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  <TD nowrap>(Former name or former address if changed since last report.)</TD>
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<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;7.01Regulation&nbsp;FD Disclosure</B>

<P style="font-size: 10pt" align="left">On December&nbsp;5, 2008 Australian Eastern Standard Time (December&nbsp;4,
2008 US Eastern Standard Time), HeartWare International, Inc. (ASX: HIN) announced, via an Australian Securities
Exchange (&#8220;ASX&#8221;) announcement, the completion of patient enrolment in the international clinical trial of
the HeartWare<SUP>&#174;</SUP> Ventricular Assist System (HVAD<SUP>&#8482;</SUP>). A total of 50 patients were enrolled
in the trial across 5 participating centres in Europe and Australia.

<P style="font-size: 10pt" align="left">The 50 patients who have been implanted with the HeartWare<SUP>&#174;</SUP>
HVAD have been supported by the system for an average of 250&nbsp;days each. A total of 12 patients have received heart
transplants after being supported for an average of 266&nbsp;days each. Three patients had their device removed after
recovery of their heart function. Four patients died on support within the first 180&nbsp;days of their implant. One
additional patient death occurred beyond 180&nbsp;days. 31 patients have successfully met the endpoint of the trial
(180&nbsp;days or transplant). A further 15 patients remain on support but have yet to reach the 180&nbsp;day endpoint.

<P style="font-size: 10pt" align="left">HeartWare&#8217;s application to apply the CE Mark to the
HeartWare<SUP>&#174;</SUP> System was based on data from the first 25 patients and this data is presently under
independent clinical review. HeartWare reiterates its expectation that CE Mark will be granted in the weeks ahead. With
the completion of the international trial, HeartWare&#8217;s two core areas of focus are now to manage the
Company&#8217;s US clinical trial and, in parallel, to drive an effective commercial launch and subsequent rollout in
Europe and Australia following receipt of CE Mark.

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

<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 ASX announcement dated December&nbsp;5, 2008, Australian
Eastern Standard Time.

<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.

<P style="font-size: 10pt; margin-left: 46%" align="left">HeartWare Limited

<P style="font-size: 10pt" align="left">Date: December&nbsp;04, 2008

<P style="margin-top: -11pt; font-size: 10pt; margin-left: 46%" align="left">By: <U><B>/</B>s/ David
McIntyre&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;</U>
<BR>
Name: David McIntyre <BR>
Title: Chief Financial Officer and Chief Business Officer

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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): December 4, 2008
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
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 7.01Regulation FD Disclosure
On December 5, 2008 Australian Eastern Standard Time (December 4,
2008 US Eastern Standard Time), HeartWare International, Inc. (ASX: HIN) announced, via an Australian Securities
Exchange ("ASX") announcement, the completion of patient enrolment in the international clinical trial of
the HeartWare
®
Ventricular Assist System (HVAD
™
). A total of 50 patients were enrolled
in the trial across 5 participating centres in Europe and Australia.
The 50 patients who have been implanted with the HeartWare
®
HVAD have been supported by the system for an average of 250 days each. A total of 12 patients have received heart
transplants after being supported for an average of 266 days each. Three patients had their device removed after
recovery of their heart function. Four patients died on support within the first 180 days of their implant. One
additional patient death occurred beyond 180 days. 31 patients have successfully met the endpoint of the trial
(180 days or transplant). A further 15 patients remain on support but have yet to reach the 180 day endpoint.
HeartWare's application to apply the CE Mark to the
HeartWare
®
System was based on data from the first 25 patients and this data is presently under
independent clinical review. HeartWare reiterates its expectation that CE Mark will be granted in the weeks ahead. With
the completion of the international trial, HeartWare's two core areas of focus are now to manage the
Company's US clinical trial and, in parallel, to drive an effective commercial launch and subsequent rollout in
Europe and Australia following receipt of CE Mark.
A complete copy of the announcement is attached as an exhibit.
Item 9.01 Financial Statements and Exhibits
Exhibit 99.1 ASX announcement dated December 5, 2008, Australian
Eastern Standard Time.
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 Limited
Date: December 04, 2008
By:
/
s/ David
McIntyre
Name: David McIntyre
Title: Chief Financial Officer and Chief Business Officer