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 <P STYLE="line-height:3.0pt;margin-top:0pt;margin-bottom:2pt;border-bottom:1px solid #000000">&nbsp;</P>
<P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:18pt; font-family:Times New Roman" ALIGN="center"><B>UNITED STATES </B></P> <P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:18pt; font-family:Times New Roman" ALIGN="center"><B>SECURITIES
AND EXCHANGE COMMISSION </B></P> <P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman" ALIGN="center"><B>Washington, D.C. 20549 </B></P>
<P STYLE="font-size:12pt;margin-top:0pt;margin-bottom:0pt">&nbsp;</P><center> <P STYLE="line-height:6.0pt;margin-top:0pt;margin-bottom:2pt;border-bottom:1.00pt solid #000000;width:21%">&nbsp;</P></center>
<P STYLE="margin-top:6pt; margin-bottom:0pt; font-size:18pt; font-family:Times New Roman" ALIGN="center"><B>FORM <FONT STYLE="white-space:nowrap">8-K</FONT> </B></P> <P STYLE="font-size:6pt;margin-top:0pt;margin-bottom:0pt">&nbsp;</P><center>
<P STYLE="line-height:6.0pt;margin-top:0pt;margin-bottom:2pt;border-bottom:1.00pt solid #000000;width:21%">&nbsp;</P></center> <P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman" ALIGN="center"><B>CURRENT
REPORT </B></P> <P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman" ALIGN="center"><B>Pursuant to Section&nbsp;13 or 15(d) </B></P>
<P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman" ALIGN="center"><B>of The Securities Exchange Act of 1934 </B></P>
<P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman" ALIGN="center"><B>Date of Report (Date of earliest event reported): February&nbsp;4, 2019 </B></P>
<P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman" ALIGN="center"><B>(Date of earliest event reported) </B></P> <P STYLE="font-size:12pt;margin-top:0pt;margin-bottom:0pt">&nbsp;</P><center>
<P STYLE="line-height:6.0pt;margin-top:0pt;margin-bottom:2pt;border-bottom:1.00pt solid #000000;width:21%">&nbsp;</P></center> <P STYLE="margin-top:6pt; margin-bottom:0pt; font-size:24pt; font-family:Times New Roman" ALIGN="center"><B>ABIOMED, Inc.
</B></P> <P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman" ALIGN="center"><B>(Exact name of registrant as specified in its charter) </B></P>
<P STYLE="font-size:6pt;margin-top:0pt;margin-bottom:0pt">&nbsp;</P><center> <P STYLE="line-height:6.0pt;margin-top:0pt;margin-bottom:2pt;border-bottom:1.00pt solid #000000;width:21%">&nbsp;</P></center>
<P STYLE="font-size:12pt;margin-top:0pt;margin-bottom:0pt">&nbsp;</P>
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<TD VALIGN="top" ALIGN="center"><B>Delaware</B></TD>
<TD VALIGN="bottom">&nbsp;</TD>
<TD VALIGN="top" ALIGN="center"><B><FONT STYLE="white-space:nowrap">001-09585</FONT></B></TD>
<TD VALIGN="bottom">&nbsp;</TD>
<TD VALIGN="top" ALIGN="center"><B><FONT STYLE="white-space:nowrap">04-2743260</FONT></B></TD></TR>
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<TD VALIGN="top" ALIGN="center"> <P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:8pt; font-family:Times New Roman" ALIGN="center"><B>(State or other Jurisdiction</B></P>
<P STYLE="margin-top:0pt; margin-bottom:1pt; font-size:8pt; font-family:Times New Roman" ALIGN="center"><B>of Incorporation)</B></P></TD>
<TD VALIGN="bottom">&nbsp;</TD>
<TD VALIGN="top" ALIGN="center"> <P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:8pt; font-family:Times New Roman" ALIGN="center"><B>(Commission</B></P>
<P STYLE="margin-top:0pt; margin-bottom:1pt; font-size:8pt; font-family:Times New Roman" ALIGN="center"><B>File Number)</B></P></TD>
<TD VALIGN="bottom">&nbsp;</TD>
<TD VALIGN="top" ALIGN="center"> <P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:8pt; font-family:Times New Roman" ALIGN="center"><B>(IRS Employer</B></P>
<P STYLE="margin-top:0pt; margin-bottom:1pt; font-size:8pt; font-family:Times New Roman" ALIGN="center"><B>Identification Number)</B></P></TD></TR>
</TABLE> <P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman" ALIGN="center"><B>22 Cherry Hill Drive </B></P>
<P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman" ALIGN="center"><B>Danvers, MA 01923 </B></P>
<P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:8pt; font-family:Times New Roman" ALIGN="center"><B>(Address of Principal Executive Offices, including Zip Code) </B></P>
<P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman" ALIGN="center"><B>(978) <FONT STYLE="white-space:nowrap">646-1400</FONT> </B></P>
<P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:8pt; font-family:Times New Roman" ALIGN="center"><B>(Registrant&#146;s Telephone Number, including Area Code) </B></P>
<P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman" ALIGN="center"><B>Not Applicable </B></P> <P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:8pt; font-family:Times New Roman" ALIGN="center"><B>(Former
Name or Former Address, if Changed Since Last Report) </B></P> <P STYLE="font-size:6pt;margin-top:0pt;margin-bottom:0pt">&nbsp;</P><center>
<P STYLE="line-height:6.0pt;margin-top:0pt;margin-bottom:2pt;border-bottom:1.00pt solid #000000;width:21%">&nbsp;</P></center> <P STYLE="margin-top:6pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman">Check the appropriate box below
if the <FONT STYLE="white-space:nowrap">Form&nbsp;8-K</FONT> filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions: </P>
<P STYLE="font-size:6pt;margin-top:0pt;margin-bottom:0pt">&nbsp;</P>
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<TD ALIGN="left" VALIGN="top"> <P STYLE=" margin-top:0pt ; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman; " ALIGN="left">Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425) </P></TD></TR></TABLE>
<P STYLE="font-size:6pt;margin-top:0pt;margin-bottom:0pt">&nbsp;</P>
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<TD WIDTH="4%" VALIGN="top" ALIGN="left">&#9744;</TD>
<TD ALIGN="left" VALIGN="top"> <P STYLE=" margin-top:0pt ; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman; " ALIGN="left">Soliciting material pursuant to Rule <FONT STYLE="white-space:nowrap">14a-12</FONT> under the Exchange Act (17
CFR <FONT STYLE="white-space:nowrap">240.14a-12)</FONT> </P></TD></TR></TABLE> <P STYLE="font-size:6pt;margin-top:0pt;margin-bottom:0pt">&nbsp;</P>
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<TD WIDTH="4%" VALIGN="top" ALIGN="left">&#9744;</TD>
<TD ALIGN="left" VALIGN="top"> <P STYLE=" margin-top:0pt ; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman; " ALIGN="left"><FONT STYLE="white-space:nowrap">Pre-commencement</FONT> communications pursuant to Rule <FONT
STYLE="white-space:nowrap">14d-2(b)</FONT> under the Exchange Act (17 CFR <FONT STYLE="white-space:nowrap">240.14d-2(b))</FONT> </P></TD></TR></TABLE> <P STYLE="font-size:6pt;margin-top:0pt;margin-bottom:0pt">&nbsp;</P>
<TABLE STYLE="BORDER-COLLAPSE:COLLAPSE; font-family:Times New Roman; font-size:10pt" BORDER="0" CELLPADDING="0" CELLSPACING="0" WIDTH="100%">
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<TD WIDTH="4%" VALIGN="top" ALIGN="left">&#9744;</TD>
<TD ALIGN="left" VALIGN="top"> <P STYLE=" margin-top:0pt ; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman; " ALIGN="left"><FONT STYLE="white-space:nowrap">Pre-commencement</FONT> communications pursuant to Rule <FONT
STYLE="white-space:nowrap">13e-4(c)</FONT> under the Exchange Act (17 CFR <FONT STYLE="white-space:nowrap">240.13e-4(c)</FONT> </P></TD></TR></TABLE> <P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman">Indicate
by check mark whether the registrant is an emerging growth company as defined in Rule&nbsp;405 of the Securities Act of 1933 (&#167;230.405 of this chapter) or Rule <FONT STYLE="white-space:nowrap">12b-2</FONT> of the Securities Exchange Act of 1934
<FONT STYLE="white-space:nowrap">(&#167;240.12b-2</FONT> of this chapter). </P> <P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman">Emerging growth company&nbsp;&#9744; </P>
<P STYLE="margin-top:6pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman">If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or
revised financial accounting standards provided pursuant to Section&nbsp;13(a) of the Exchange Act.&nbsp;&#9744;</P> <P STYLE="font-size:12pt;margin-top:0pt;margin-bottom:0pt">&nbsp;</P>
<P STYLE="line-height:3.0pt;margin-top:0pt;margin-bottom:2pt;border-bottom:1px solid #000000">&nbsp;</P>
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<TD WIDTH="9%" VALIGN="top" ALIGN="left"><B>Item&nbsp;8.01</B></TD>
<TD ALIGN="left" VALIGN="top"> <P STYLE=" margin-top:0pt ; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman; " ALIGN="left"><B>Other Events. </B></P></TD></TR></TABLE>
<P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman" ALIGN="center"><B>Statement from Abiomed on RP Notification </B></P>
<P STYLE="margin-top:6pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman">Abiomed is committed to proactively sharing data to inform the medical community of best practices for use of the Impella RP<SUP
STYLE="font-size:85%; vertical-align:top">&reg;</SUP> heart pump and to continue to improve outcomes for patients.</P> <P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman">The Impella RP is the only device with
FDA PMA approval for right side support. FDA studies demonstrate that proper use and timely implantation of Impella RP increases survival with the potential for recovery of the right ventricle [i] [ii].&nbsp;The data below was published in December,
2018: </P> <P STYLE="margin-top:18pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman"><B>Impella RP PMA Cohort Study Results (N=60) </B></P> <P STYLE="font-size:12pt;margin-top:0pt;margin-bottom:0pt">&nbsp;</P>
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<TD VALIGN="bottom" STYLE="border-bottom:1.00pt solid #000000"> <P STYLE="margin-top:0pt; margin-bottom:1pt; font-size:10pt; font-family:Times New Roman"><B>Survival Rates</B></P></TD></TR>


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<TD VALIGN="top"> <P STYLE="margin-top:0pt; margin-bottom:0pt; margin-left:1.00em; text-indent:-1.00em; font-size:10pt; font-family:Times New Roman">PMA Subjects (RR + CAP + HDE PAS) &#150; full cohort (N=60)</P>
<P STYLE="margin-top:0pt; margin-bottom:0pt; margin-left:1.00em; text-indent:-1.00em; font-size:10pt; font-family:Times New Roman">&nbsp;&nbsp;&nbsp;&nbsp;Cohort A (N=31)</P>
<P STYLE="margin-top:0pt; margin-bottom:1pt; margin-left:1.00em; text-indent:-1.00em; font-size:10pt; font-family:Times New Roman">&nbsp;&nbsp;&nbsp;&nbsp;Cohort B (N=29)</P></TD>
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<TD VALIGN="top"> <P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman">73% (44/60)</P> <P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman">77% (24/31)</P>
<P STYLE="margin-top:0pt; margin-bottom:1pt; font-size:10pt; font-family:Times New Roman">69% (20/29)</P></TD></TR>
</TABLE> <P STYLE="margin-top:6pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman" ALIGN="right"><I>Journal of Heart and Lung Transplant, December 2018(37) </I></P>
<P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman">On January&nbsp;31, 2019, Abiomed proactively sent physicians who use Impella RP post-approval study (PAS) data that provides additional evidence of the
benefits of following proper protocols for placement of Impella RP.&nbsp;The data is summarized in the table below and demonstrates the importance of early placement of Impella RP, and the importance of following proper inclusion and exclusion
criteria when selecting patients for Impella RP.</P> <P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman">The PMA cohort (n=60) had 73% survival and the PAS cohort (n=23) is currently at 17%. This PAS population
has 70% (16/23) outside the recommended treatment protocol inclusion and exclusion criteria, and as a result survival rates are lower.&nbsp;These patients were critically ill and, in some cases, had been in profound shock for more than 48
hours.&nbsp;As such, these patients were statistically sicker and may not have been appropriate candidates to benefit from right side mechanical circulatory support. </P> <P STYLE="font-size:12pt;margin-top:0pt;margin-bottom:0pt">&nbsp;</P>
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<TD VALIGN="bottom" STYLE="BORDER-BOTTOM:1.00pt solid #000000"><B>Characteristics</B></TD>
<TD VALIGN="bottom" STYLE=" BORDER-BOTTOM:1.00pt solid #000000">&nbsp;&nbsp;</TD>
<TD VALIGN="bottom" COLSPAN="2" ALIGN="center" STYLE="BORDER-BOTTOM:1.00pt solid #000000"> <P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:8pt; font-family:Times New Roman" ALIGN="center"><B>Impella RP</B></P>
<P STYLE="margin-top:0pt; margin-bottom:1pt; font-size:8pt; font-family:Times New Roman" ALIGN="center"><B><FONT STYLE="white-space:nowrap">Pre-Market</FONT><BR>Application&nbsp;(PMA)<BR>Study<BR>(N=60 Patients)</B></P></TD>
<TD VALIGN="bottom" STYLE=" BORDER-BOTTOM:1.00pt solid #000000">&nbsp;</TD>
<TD VALIGN="bottom" STYLE=" BORDER-BOTTOM:1.00pt solid #000000">&nbsp;&nbsp;</TD>
<TD VALIGN="bottom" COLSPAN="2" ALIGN="center" STYLE="BORDER-BOTTOM:1.00pt solid #000000"> <P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:8pt; font-family:Times New Roman" ALIGN="center"><B>Impella RP</B></P>
<P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:8pt; font-family:Times New Roman" ALIGN="center"><B>Post-Market<BR>Approval</B></P>
<P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:8pt; font-family:Times New Roman" ALIGN="center"><B>(PMS)&nbsp;Report</B></P>
<P STYLE="margin-top:0pt; margin-bottom:1pt; font-size:8pt; font-family:Times New Roman" ALIGN="center"><B>(N=23&nbsp;Patients)</B></P></TD>
<TD VALIGN="bottom" STYLE=" BORDER-BOTTOM:1.00pt solid #000000">&nbsp;</TD>
<TD VALIGN="bottom" STYLE=" BORDER-BOTTOM:1.00pt solid #000000">&nbsp;&nbsp;</TD>
<TD VALIGN="bottom" COLSPAN="2" ALIGN="center" STYLE="BORDER-BOTTOM:1.00pt solid #000000"><B><FONT STYLE="white-space:nowrap">P-Value</FONT></B></TD>
<TD VALIGN="bottom" STYLE=" BORDER-BOTTOM:1.00pt solid #000000">&nbsp;</TD></TR>


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<TD VALIGN="top"> <P STYLE=" margin-top:0pt ; margin-bottom:0pt; margin-left:1.00em; text-indent:-1.00em; font-size:10pt; font-family:Times New Roman">Age</P></TD>
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<TD VALIGN="top"> <P STYLE=" margin-top:0pt ; margin-bottom:0pt; margin-left:3.00em; text-indent:-1.00em; font-size:10pt; font-family:Times New Roman">Mean&plusmn;SD(N)</P></TD>
<TD VALIGN="bottom">&nbsp;&nbsp;</TD>
<TD VALIGN="bottom">&nbsp;</TD>
<TD VALIGN="bottom" ALIGN="center">58.58&plusmn;15.12(60)</TD>
<TD NOWRAP VALIGN="bottom">&nbsp;</TD>
<TD VALIGN="bottom">&nbsp;&nbsp;</TD>
<TD VALIGN="bottom">&nbsp;</TD>
<TD VALIGN="bottom" ALIGN="center">65.61&plusmn;13.72(23)</TD>
<TD NOWRAP VALIGN="bottom">&nbsp;</TD>
<TD VALIGN="bottom">&nbsp;&nbsp;</TD>
<TD VALIGN="bottom">&nbsp;</TD>
<TD VALIGN="bottom" ALIGN="center">0.056</TD>
<TD NOWRAP VALIGN="bottom">&nbsp;</TD></TR>
<TR STYLE="page-break-inside:avoid ; font-family:Times New Roman; font-size:10pt">
<TD VALIGN="top"> <P STYLE=" margin-top:0pt ; margin-bottom:0pt; margin-left:1.00em; text-indent:-1.00em; font-size:10pt; font-family:Times New Roman">Did the patient experience an <FONT STYLE="white-space:nowrap">in-hospital</FONT> cardiac arrest
prior to Impella implant</P></TD>
<TD VALIGN="bottom" BGCOLOR="#cccccc">&nbsp;&nbsp;</TD>
<TD VALIGN="bottom" BGCOLOR="#cccccc">&nbsp;</TD>
<TD VALIGN="bottom" BGCOLOR="#cccccc" ALIGN="center">0.00% (0/60)</TD>
<TD NOWRAP VALIGN="bottom" BGCOLOR="#cccccc">&nbsp;</TD>
<TD VALIGN="bottom" BGCOLOR="#cccccc">&nbsp;&nbsp;</TD>
<TD VALIGN="bottom" BGCOLOR="#cccccc">&nbsp;</TD>
<TD VALIGN="bottom" BGCOLOR="#cccccc" ALIGN="center">56.52% (13/23)</TD>
<TD NOWRAP VALIGN="bottom" BGCOLOR="#cccccc">&nbsp;</TD>
<TD VALIGN="bottom" BGCOLOR="#cccccc">&nbsp;&nbsp;</TD>
<TD VALIGN="bottom" BGCOLOR="#cccccc">&nbsp;</TD>
<TD VALIGN="bottom" BGCOLOR="#cccccc" ALIGN="center">&lt;.001</TD>
<TD NOWRAP VALIGN="bottom" BGCOLOR="#cccccc">&nbsp;</TD></TR>
<TR STYLE="page-break-inside:avoid ; font-family:Times New Roman; font-size:10pt">
<TD VALIGN="top"> <P STYLE=" margin-top:0pt ; margin-bottom:0pt; margin-left:1.00em; text-indent:-1.00em; font-size:10pt; font-family:Times New Roman">At the time of Impella implant did the patient receive CPR/ACLS</P></TD>
<TD VALIGN="bottom" BGCOLOR="#cccccc">&nbsp;&nbsp;</TD>
<TD VALIGN="bottom" BGCOLOR="#cccccc">&nbsp;</TD>
<TD VALIGN="bottom" BGCOLOR="#cccccc" ALIGN="center">0.05% (3/60)</TD>
<TD NOWRAP VALIGN="bottom" BGCOLOR="#cccccc">&nbsp;</TD>
<TD VALIGN="bottom" BGCOLOR="#cccccc">&nbsp;&nbsp;</TD>
<TD VALIGN="bottom" BGCOLOR="#cccccc">&nbsp;</TD>
<TD VALIGN="bottom" BGCOLOR="#cccccc" ALIGN="center">30.43% (7/23)</TD>
<TD NOWRAP VALIGN="bottom" BGCOLOR="#cccccc">&nbsp;</TD>
<TD VALIGN="bottom" BGCOLOR="#cccccc">&nbsp;&nbsp;</TD>
<TD VALIGN="bottom" BGCOLOR="#cccccc">&nbsp;</TD>
<TD VALIGN="bottom" BGCOLOR="#cccccc" ALIGN="center">&lt;.001</TD>
<TD NOWRAP VALIGN="bottom" BGCOLOR="#cccccc">&nbsp;</TD></TR>
<TR STYLE="page-break-inside:avoid ; font-family:Times New Roman; font-size:10pt">
<TD VALIGN="top"> <P STYLE=" margin-top:0pt ; margin-bottom:0pt; margin-left:1.00em; text-indent:-1.00em; font-size:10pt; font-family:Times New Roman">Was there evidence of hypoxicischemic brain injury prior to Impella implant</P></TD>
<TD VALIGN="bottom" BGCOLOR="#cccccc">&nbsp;&nbsp;</TD>
<TD VALIGN="bottom" BGCOLOR="#cccccc">&nbsp;</TD>
<TD VALIGN="bottom" BGCOLOR="#cccccc" ALIGN="center">0.00% (0/60)</TD>
<TD NOWRAP VALIGN="bottom" BGCOLOR="#cccccc">&nbsp;</TD>
<TD VALIGN="bottom" BGCOLOR="#cccccc">&nbsp;&nbsp;</TD>
<TD VALIGN="bottom" BGCOLOR="#cccccc">&nbsp;</TD>
<TD VALIGN="bottom" BGCOLOR="#cccccc" ALIGN="center">14.29% (3/21)</TD>
<TD NOWRAP VALIGN="bottom" BGCOLOR="#cccccc">&nbsp;</TD>
<TD VALIGN="bottom" BGCOLOR="#cccccc">&nbsp;&nbsp;</TD>
<TD VALIGN="bottom" BGCOLOR="#cccccc">&nbsp;</TD>
<TD VALIGN="bottom" BGCOLOR="#cccccc" ALIGN="center">0.016</TD>
<TD NOWRAP VALIGN="bottom" BGCOLOR="#cccccc">&nbsp;</TD></TR>
<TR STYLE="page-break-inside:avoid ; font-family:Times New Roman; font-size:10pt">
<TD VALIGN="top"> <P STYLE=" margin-top:0pt ; margin-bottom:0pt; margin-left:1.00em; text-indent:-1.00em; font-size:10pt; font-family:Times New Roman">Was the patient supported with inotrope or vasopressors prior to Impella implant</P></TD>
<TD VALIGN="bottom">&nbsp;&nbsp;</TD>
<TD VALIGN="bottom">&nbsp;</TD>
<TD VALIGN="bottom" ALIGN="center">98.33% (59/60)</TD>
<TD NOWRAP VALIGN="bottom">&nbsp;</TD>
<TD VALIGN="bottom">&nbsp;&nbsp;</TD>
<TD VALIGN="bottom">&nbsp;</TD>
<TD VALIGN="bottom" ALIGN="center">86.96% (20/23)</TD>
<TD NOWRAP VALIGN="bottom">&nbsp;</TD>
<TD VALIGN="bottom">&nbsp;&nbsp;</TD>
<TD VALIGN="bottom">&nbsp;</TD>
<TD VALIGN="bottom" ALIGN="center">0.063</TD>
<TD NOWRAP VALIGN="bottom">&nbsp;</TD></TR>
<TR STYLE="page-break-inside:avoid ; font-family:Times New Roman; font-size:10pt">
<TD VALIGN="top"> <P STYLE=" margin-top:0pt ; margin-bottom:0pt; margin-left:2.00em; text-indent:-1.00em; font-size:10pt; font-family:Times New Roman">If yes, Indicate total number of inotrope or vasopressors</P></TD>
<TD VALIGN="bottom">&nbsp;&nbsp;</TD>
<TD VALIGN="bottom"></TD>
<TD VALIGN="bottom"></TD>
<TD VALIGN="bottom"></TD>
<TD VALIGN="bottom">&nbsp;&nbsp;</TD>
<TD VALIGN="bottom"></TD>
<TD VALIGN="bottom"></TD>
<TD VALIGN="bottom"></TD>
<TD VALIGN="bottom">&nbsp;&nbsp;</TD>
<TD VALIGN="bottom"></TD>
<TD VALIGN="bottom"></TD>
<TD VALIGN="bottom"></TD></TR>
<TR STYLE="page-break-inside:avoid ; font-family:Times New Roman; font-size:10pt">
<TD VALIGN="top"> <P STYLE=" margin-top:0pt ; margin-bottom:0pt; margin-left:3.00em; text-indent:-1.00em; font-size:10pt; font-family:Times New Roman">Mean&plusmn;SD(N)</P></TD>
<TD VALIGN="bottom" BGCOLOR="#cccccc">&nbsp;&nbsp;</TD>
<TD VALIGN="bottom" BGCOLOR="#cccccc">&nbsp;</TD>
<TD VALIGN="bottom" BGCOLOR="#cccccc" ALIGN="center">3.37&plusmn;1.24(59)</TD>
<TD NOWRAP VALIGN="bottom" BGCOLOR="#cccccc">&nbsp;</TD>
<TD VALIGN="bottom" BGCOLOR="#cccccc">&nbsp;&nbsp;</TD>
<TD VALIGN="bottom" BGCOLOR="#cccccc">&nbsp;</TD>
<TD VALIGN="bottom" BGCOLOR="#cccccc" ALIGN="center">4.38&plusmn;1.56(13)</TD>
<TD NOWRAP VALIGN="bottom" BGCOLOR="#cccccc">&nbsp;</TD>
<TD VALIGN="bottom" BGCOLOR="#cccccc">&nbsp;&nbsp;</TD>
<TD VALIGN="bottom" BGCOLOR="#cccccc">&nbsp;</TD>
<TD VALIGN="bottom" BGCOLOR="#cccccc" ALIGN="center">0.014</TD>
<TD NOWRAP VALIGN="bottom" BGCOLOR="#cccccc">&nbsp;</TD></TR>
<TR STYLE="page-break-inside:avoid ; font-family:Times New Roman; font-size:10pt">
<TD VALIGN="top"> <P STYLE=" margin-top:0pt ; margin-bottom:0pt; margin-left:3.00em; text-indent:-1.00em; font-size:10pt; font-family:Times New Roman">Median</P></TD>
<TD VALIGN="bottom">&nbsp;&nbsp;</TD>
<TD VALIGN="bottom">&nbsp;</TD>
<TD VALIGN="bottom" ALIGN="center">3.00</TD>
<TD NOWRAP VALIGN="bottom">&nbsp;</TD>
<TD VALIGN="bottom">&nbsp;&nbsp;</TD>
<TD VALIGN="bottom">&nbsp;</TD>
<TD VALIGN="bottom" ALIGN="center">4.00</TD>
<TD NOWRAP VALIGN="bottom">&nbsp;</TD>
<TD VALIGN="bottom">&nbsp;&nbsp;</TD>
<TD VALIGN="bottom"></TD>
<TD VALIGN="bottom"></TD>
<TD VALIGN="bottom"></TD></TR>
<TR STYLE="page-break-inside:avoid ; font-family:Times New Roman; font-size:10pt">
<TD VALIGN="top"> <P STYLE=" margin-top:0pt ; margin-bottom:0pt; margin-left:1.00em; text-indent:-1.00em; font-size:10pt; font-family:Times New Roman">Range (Min, Max)</P></TD>
<TD VALIGN="bottom">&nbsp;&nbsp;</TD>
<TD VALIGN="bottom">&nbsp;</TD>
<TD VALIGN="bottom" ALIGN="center">(1.00,6.00)</TD>
<TD NOWRAP VALIGN="bottom">&nbsp;</TD>
<TD VALIGN="bottom">&nbsp;&nbsp;</TD>
<TD VALIGN="bottom">&nbsp;</TD>
<TD VALIGN="bottom" ALIGN="center">(2.00,8.00)</TD>
<TD NOWRAP VALIGN="bottom">&nbsp;</TD>
<TD VALIGN="bottom">&nbsp;&nbsp;</TD>
<TD VALIGN="bottom"></TD>
<TD VALIGN="bottom"></TD>
<TD VALIGN="bottom"></TD></TR>
<TR STYLE="page-break-inside:avoid ; font-family:Times New Roman; font-size:10pt">
<TD VALIGN="top"> <P STYLE=" margin-top:0pt ; margin-bottom:0pt; margin-left:1.00em; text-indent:-1.00em; font-size:10pt; font-family:Times New Roman">Patients in shock &gt;=48 hours</P></TD>
<TD VALIGN="bottom" BGCOLOR="#cccccc">&nbsp;&nbsp;</TD>
<TD VALIGN="bottom" BGCOLOR="#cccccc">&nbsp;</TD>
<TD VALIGN="bottom" BGCOLOR="#cccccc" ALIGN="center">0.00% (0/34)</TD>
<TD NOWRAP VALIGN="bottom" BGCOLOR="#cccccc">&nbsp;</TD>
<TD VALIGN="bottom" BGCOLOR="#cccccc">&nbsp;&nbsp;</TD>
<TD VALIGN="bottom" BGCOLOR="#cccccc">&nbsp;</TD>
<TD VALIGN="bottom" BGCOLOR="#cccccc" ALIGN="center">26.09% (6/23)</TD>
<TD NOWRAP VALIGN="bottom" BGCOLOR="#cccccc">&nbsp;</TD>
<TD VALIGN="bottom" BGCOLOR="#cccccc">&nbsp;&nbsp;</TD>
<TD VALIGN="bottom" BGCOLOR="#cccccc">&nbsp;</TD>
<TD VALIGN="bottom" BGCOLOR="#cccccc" ALIGN="center">&lt;.001</TD>
<TD NOWRAP VALIGN="bottom" BGCOLOR="#cccccc">&nbsp;</TD></TR>
<TR STYLE="page-break-inside:avoid ; font-family:Times New Roman; font-size:10pt">
<TD VALIGN="top" STYLE="BORDER-BOTTOM:1px solid #000000"> <P STYLE=" margin-top:0pt ; margin-bottom:0pt; margin-left:1.00em; text-indent:-1.00em; font-size:10pt; font-family:Times New Roman">IABP used prior to Impella implant</P></TD>
<TD VALIGN="bottom" BGCOLOR="#cccccc" STYLE=" BORDER-BOTTOM:1px solid #000000">&nbsp;&nbsp;</TD>
<TD VALIGN="bottom" STYLE="BORDER-BOTTOM:1px solid #000000" BGCOLOR="#cccccc">&nbsp;</TD>
<TD VALIGN="bottom" STYLE="BORDER-BOTTOM:1px solid #000000" BGCOLOR="#cccccc" ALIGN="center">0.00% (0/60)</TD>
<TD NOWRAP VALIGN="bottom" STYLE="BORDER-BOTTOM:1px solid #000000" BGCOLOR="#cccccc">&nbsp;</TD>
<TD VALIGN="bottom" BGCOLOR="#cccccc" STYLE=" BORDER-BOTTOM:1px solid #000000">&nbsp;&nbsp;</TD>
<TD VALIGN="bottom" STYLE="BORDER-BOTTOM:1px solid #000000" BGCOLOR="#cccccc">&nbsp;</TD>
<TD VALIGN="bottom" STYLE="BORDER-BOTTOM:1px solid #000000" BGCOLOR="#cccccc" ALIGN="center">30.43% (7/23)</TD>
<TD NOWRAP VALIGN="bottom" STYLE="BORDER-BOTTOM:1px solid #000000" BGCOLOR="#cccccc">&nbsp;</TD>
<TD VALIGN="bottom" BGCOLOR="#cccccc" STYLE=" BORDER-BOTTOM:1px solid #000000">&nbsp;&nbsp;</TD>
<TD VALIGN="bottom" STYLE="BORDER-BOTTOM:1px solid #000000" BGCOLOR="#cccccc">&nbsp;</TD>
<TD VALIGN="bottom" STYLE="BORDER-BOTTOM:1px solid #000000" BGCOLOR="#cccccc" ALIGN="center">&lt;.001</TD>
<TD NOWRAP VALIGN="bottom" STYLE="BORDER-BOTTOM:1px solid #000000" BGCOLOR="#cccccc">&nbsp;</TD></TR>
</TABLE> <P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman">Abiomed encourages all clinicians to review proper inclusion and exclusion criteria for Impella RP.&nbsp;To help physicians
determine if Impella RP is right for their patients, Abiomed has created an <FONT STYLE="white-space:nowrap">FDA-approved</FONT> checklist to guide treatment decisions and encourages the use of physician guidelines such as the National Cardiogenic
Shock Initiative (<U>https://www.henryford.com/cardiogenicshock/protocol</U>) and the Shock Care Pathway Algorithms (<U>http://www.onlinejacc.org/content/72/16/1972</U>). The checklist is available at <U>https://www.protectedpci.com/resources/</U>.
Right side failure remains a more difficult diagnosis than left side failure based on clinical experience and lower occurrence in clinical practice. </P> <P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman">As a
leader in post-market surveillance to improve patient outcomes, Abiomed tracks outcomes on nearly 100% of its Impella RP patients. The manufacturers of other technologies for right side support are cleared for less than 6 hours of support (ECMO,
TandemLife<SUP STYLE="font-size:85%; vertical-align:top">&reg;</SUP>) and as a result, do not have regulatory responsibility to track and publically report a post approval study (PAS) on their patient outcomes. Abiomed will
</P>
</DIV></Center>


<p Style='page-break-before:always'>
<HR  SIZE="3" style="COLOR:#999999" WIDTH="100%" ALIGN="CENTER">


<Center><DIV STYLE="width:8.5in" align="left">
 <P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman">
continue to focus on improving clinical outcomes for both left and right ventricular failure by advancing innovation, identifying best practices and providing 24x7
<FONT STYLE="white-space:nowrap">on-site</FONT> and <FONT STYLE="white-space:nowrap">on-call</FONT> support to address the clinical crisis of cardiogenic shock in today&#146;s healthcare system. </P>
<P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman">[i] <I>Journal of Heart and Lung Transplant, December 2015(34)</I> </P>
<P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman">[ii] <I>Journal of Heart and Lung Transplant, December 2018(37)</I> </P>
</DIV></Center>


<p Style='page-break-before:always'>
<HR  SIZE="3" style="COLOR:#999999" WIDTH="100%" ALIGN="CENTER">


<Center><DIV STYLE="width:8.5in" align="left">
 <P STYLE="line-height:1.0pt;margin-top:0pt;margin-bottom:2pt;border-bottom:1.00pt solid #000000">&nbsp;</P>
<P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman" ALIGN="center"><B>SIGNATURES </B></P> <P STYLE="margin-top:6pt; margin-bottom:0pt; text-indent:4%; font-size:10pt; font-family:Times New Roman">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 thereunto duly authorized. </P>
<P STYLE="font-size:12pt;margin-top:0pt;margin-bottom:0pt">&nbsp;</P><DIV ALIGN="right">
<TABLE CELLSPACING="0" CELLPADDING="0" WIDTH="40%" BORDER="0" STYLE="BORDER-COLLAPSE:COLLAPSE; font-family:Times New Roman; font-size:10pt">


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<TD WIDTH="92%"></TD></TR>


<TR STYLE="page-break-inside:avoid ; font-family:Times New Roman; font-size:10pt">
<TD VALIGN="top" COLSPAN="3">Abiomed, Inc.</TD></TR>
<TR STYLE="font-size:1pt">
<TD HEIGHT="16"></TD>
<TD HEIGHT="16" COLSPAN="2"></TD></TR>
<TR STYLE="page-break-inside:avoid ; font-family:Times New Roman; font-size:10pt">
<TD VALIGN="top">By:</TD>
<TD VALIGN="bottom" STYLE=" BORDER-BOTTOM:1px solid #000000">&nbsp;</TD>
<TD VALIGN="top" STYLE="BORDER-BOTTOM:1px solid #000000">/s/ Todd A. Trapp</TD></TR>
<TR STYLE="page-break-inside:avoid ; font-family:Times New Roman; font-size:10pt">
<TD VALIGN="top"></TD>
<TD VALIGN="bottom">&nbsp;</TD>
<TD VALIGN="bottom"> <P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman">Todd A. Trapp</P> <P STYLE="margin-top:0pt; margin-bottom:1pt; font-size:10pt; font-family:Times New Roman">Vice President and Chief
Financial Officer</P></TD></TR>
</TABLE></DIV> <P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman">Date:&nbsp;February 4, 2019 </P>
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</BODY></HTML>
[{"type": "8-K", "sequence": "1", "filename": "d705404d8k.htm", "description": "8-K", "secsgml_size_bytes": 32108}]
{"company-data": {"conformed-name": "ABIOMED INC", "cik": "0000815094", "assigned-sic": "3841", "irs-number": "042743260", "state-of-incorporation": "DE", "fiscal-year-end": "0331"}, "filing-values": {"form-type": "8-K", "act": "34", "file-number": "001-09585", "film-number": "19563576"}, "business-address": {"street1": "22 CHERRY HILL DR", "city": "DANVERS", "state": "MA", "zip": "01923", "phone": "9787775410"}, "mail-address": {"street1": "22 CHERRY HILL DRIVE", "city": "DANVERS", "state": "MA", "zip": "01923"}}
8-K
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): February 4, 2019
(Date of earliest event reported)
ABIOMED, Inc.
(Exact name of registrant as specified in its charter)
Delaware
001-09585
04-2743260
(State or other Jurisdiction
of Incorporation)
(Commission
File Number)
(IRS Employer
Identification Number)
22 Cherry Hill Drive
Danvers, MA 01923
(Address of Principal Executive Offices, including Zip Code)
(978)
646-1400
(Registrant's Telephone Number, including Area Code)
Not Applicable
(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:
☐
Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
☐
Soliciting material pursuant to Rule
14a-12
under the Exchange Act (17
CFR
240.14a-12)
☐
Pre-commencement
communications pursuant to Rule
14d-2(b)
under the Exchange Act (17 CFR
240.14d-2(b))
☐
Pre-commencement
communications pursuant to Rule
13e-4(c)
under the Exchange Act (17 CFR
240.13e-4(c)
Indicate
by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule
12b-2
of the Securities Exchange Act of 1934
(§240.12b-2
of this chapter).
Emerging growth company ☐
If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or
revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐
Item 8.01
Other Events.
Statement from Abiomed on RP Notification
Abiomed is committed to proactively sharing data to inform the medical community of best practices for use of the Impella RP
®
heart pump and to continue to improve outcomes for patients.
The Impella RP is the only device with
FDA PMA approval for right side support. FDA studies demonstrate that proper use and timely implantation of Impella RP increases survival with the potential for recovery of the right ventricle [i] [ii]. The data below was published in December,
2018:
Impella RP PMA Cohort Study Results (N=60)
Survival Rates
PMA Subjects (RR + CAP + HDE PAS) – full cohort (N=60)
Cohort A (N=31)
Cohort B (N=29)
73% (44/60)
77% (24/31)
69% (20/29)
Journal of Heart and Lung Transplant, December 2018(37)
On January 31, 2019, Abiomed proactively sent physicians who use Impella RP post-approval study (PAS) data that provides additional evidence of the
benefits of following proper protocols for placement of Impella RP. The data is summarized in the table below and demonstrates the importance of early placement of Impella RP, and the importance of following proper inclusion and exclusion
criteria when selecting patients for Impella RP.
The PMA cohort (n=60) had 73% survival and the PAS cohort (n=23) is currently at 17%. This PAS population
has 70% (16/23) outside the recommended treatment protocol inclusion and exclusion criteria, and as a result survival rates are lower. These patients were critically ill and, in some cases, had been in profound shock for more than 48
hours. As such, these patients were statistically sicker and may not have been appropriate candidates to benefit from right side mechanical circulatory support.
Characteristics
Impella RP
Pre-Market
Application (PMA)
Study
(N=60 Patients)
Impella RP
Post-Market
Approval
(PMS) Report
(N=23 Patients)
P-Value
Age
Mean±SD(N)
58.58±15.12(60)
65.61±13.72(23)
0.056
Did the patient experience an
in-hospital
cardiac arrest
prior to Impella implant
0.00% (0/60)
56.52% (13/23)
<.001
At the time of Impella implant did the patient receive CPR/ACLS
0.05% (3/60)
30.43% (7/23)
<.001
Was there evidence of hypoxicischemic brain injury prior to Impella implant
0.00% (0/60)
14.29% (3/21)
0.016
Was the patient supported with inotrope or vasopressors prior to Impella implant
98.33% (59/60)
86.96% (20/23)
0.063
If yes, Indicate total number of inotrope or vasopressors
Mean±SD(N)
3.37±1.24(59)
4.38±1.56(13)
0.014
Median
3.00
4.00
Range (Min, Max)
(1.00,6.00)
(2.00,8.00)
Patients in shock >=48 hours
0.00% (0/34)
26.09% (6/23)
<.001
IABP used prior to Impella implant
0.00% (0/60)
30.43% (7/23)
<.001
Abiomed encourages all clinicians to review proper inclusion and exclusion criteria for Impella RP. To help physicians
determine if Impella RP is right for their patients, Abiomed has created an
FDA-approved
checklist to guide treatment decisions and encourages the use of physician guidelines such as the National Cardiogenic
Shock Initiative (
https://www.henryford.com/cardiogenicshock/protocol
) and the Shock Care Pathway Algorithms (
http://www.onlinejacc.org/content/72/16/1972
). The checklist is available at
https://www.protectedpci.com/resources/
.
Right side failure remains a more difficult diagnosis than left side failure based on clinical experience and lower occurrence in clinical practice.
As a
leader in post-market surveillance to improve patient outcomes, Abiomed tracks outcomes on nearly 100% of its Impella RP patients. The manufacturers of other technologies for right side support are cleared for less than 6 hours of support (ECMO,
TandemLife
®
) and as a result, do not have regulatory responsibility to track and publically report a post approval study (PAS) on their patient outcomes. Abiomed will
continue to focus on improving clinical outcomes for both left and right ventricular failure by advancing innovation, identifying best practices and providing 24x7
on-site
and
on-call
support to address the clinical crisis of cardiogenic shock in today's healthcare system.
[i]
Journal of Heart and Lung Transplant, December 2015(34)
[ii]
Journal of Heart and Lung Transplant, December 2018(37)
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 thereunto duly authorized.
Abiomed, Inc.
By:
/s/ Todd A. Trapp
Todd A. Trapp
Vice President and Chief
Financial Officer
Date: February 4, 2019