<SEC-DOCUMENT>0001639691-16-000022.txt : 20160111
<SEC-HEADER>0001639691-16-000022.hdr.sgml : 20160111
<ACCEPTANCE-DATETIME>20160111090747
ACCESSION NUMBER:		0001639691-16-000022
CONFORMED SUBMISSION TYPE:	8-K
PUBLIC DOCUMENT COUNT:		3
CONFORMED PERIOD OF REPORT:	20160111
ITEM INFORMATION:		Other Events
ITEM INFORMATION:		Financial Statements and Exhibits
FILED AS OF DATE:		20160111
DATE AS OF CHANGE:		20160111

FILER:

	COMPANY DATA:	
		COMPANY CONFORMED NAME:			LivaNova PLC
		CENTRAL INDEX KEY:			0001639691
		STANDARD INDUSTRIAL CLASSIFICATION:	ELECTROMEDICAL & ELECTROTHERAPEUTIC APPARATUS [3845]
		IRS NUMBER:				000000000
		STATE OF INCORPORATION:			X0
		FISCAL YEAR END:			1231

	FILING VALUES:
		FORM TYPE:		8-K
		SEC ACT:		1934 Act
		SEC FILE NUMBER:	001-37599
		FILM NUMBER:		161335257

	BUSINESS ADDRESS:	
		STREET 1:		C/O LEGALINX LIMITED
		STREET 2:		1 FETTER LANE
		CITY:			LONDON
		STATE:			X0
		ZIP:			EC4A 1BR
		BUSINESS PHONE:		448009758080

	MAIL ADDRESS:	
		STREET 1:		C/O LEGALINX LIMITED
		STREET 2:		1 FETTER LANE
		CITY:			LONDON
		STATE:			X0
		ZIP:			EC4A 1BR

	FORMER COMPANY:	
		FORMER CONFORMED NAME:	Sand Holdco Plc
		DATE OF NAME CHANGE:	20150420

	FORMER COMPANY:	
		FORMER CONFORMED NAME:	Sand Holdco Ltd
		DATE OF NAME CHANGE:	20150415
</SEC-HEADER>
<DOCUMENT>
<TYPE>8-K
<SEQUENCE>1
<FILENAME>form8_k.htm
<DESCRIPTION>FDA APPROVAL OF PERCEVAL
<TEXT>
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<div style="MARGIN-LEFT: 0pt; DISPLAY: block; MARGIN-RIGHT: 0pt; TEXT-INDENT: 0pt" align="center"><font style="FONT-SIZE: 10pt; FONT-FAMILY: Times New Roman; FONT-WEIGHT: bold; DISPLAY: inline">CURRENT REPORT</font></div>

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<div style="MARGIN-LEFT: 0pt; DISPLAY: block; MARGIN-RIGHT: 0pt; TEXT-INDENT: 0pt" align="center"><font style="FONT-SIZE: 10pt; FONT-FAMILY: Times New Roman; DISPLAY: inline">Date of Report (Date of earliest event reported): <font style="FONT-WEIGHT: bold; DISPLAY: inline">January 11, 2016 (January 8, 2016)</font></font></div>

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<div style="MARGIN-LEFT: 0pt; DISPLAY: block; MARGIN-RIGHT: 0pt; TEXT-INDENT: 0pt" align="center"><img src="livn_logo.jpg" alt="LivaNova"></div>

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<div style="MARGIN-LEFT: 0pt; DISPLAY: block; MARGIN-RIGHT: 0pt; TEXT-INDENT: 0pt" align="center"><font style="FONT-SIZE: 10pt; FONT-FAMILY: Times New Roman; DISPLAY: inline">(Exact Name of Registrant as Specified in its Charter)</font></div>

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<div style="MARGIN-LEFT: 0pt; DISPLAY: block; MARGIN-RIGHT: 0pt; TEXT-INDENT: 0pt" align="center"><font style="FONT-SIZE: 10pt; FONT-FAMILY: Times New Roman; DISPLAY: inline">(State or Other Jurisdiction</font></div>

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<div style="MARGIN-LEFT: 0pt; DISPLAY: block; MARGIN-RIGHT: 0pt; TEXT-INDENT: 0pt" align="center"><font style="FONT-SIZE: 10pt; FONT-FAMILY: Times New Roman; DISPLAY: inline">(Commission</font></div>

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<div style="MARGIN-LEFT: 0pt; DISPLAY: block; MARGIN-RIGHT: 0pt; TEXT-INDENT: 0pt" align="left"><font style="FONT-SIZE: 10pt; FONT-FAMILY: Times New Roman; DISPLAY: inline">Check the appropriate box below if the Form&#160;8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:</font></div>

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<div style="MARGIN-LEFT: 36pt; DISPLAY: block; MARGIN-RIGHT: 0pt; TEXT-INDENT: 0pt" align="left"><font style="FONT-SIZE: 10pt; FONT-FAMILY: Times New Roman; DISPLAY: inline"><font style="DISPLAY: inline" face="Wingdings">o</font> Written communications pursuant to Rule&#160;425 under the Securities Act (17 CFR 230.425)</font></div>

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<div style="MARGIN-LEFT: 0pt; DISPLAY: block; MARGIN-RIGHT: 0pt; TEXT-INDENT: 36pt" align="left"><font style="FONT-SIZE: 10pt; FONT-FAMILY: Times New Roman; DISPLAY: inline">On January 11, 2016, LivaNova PLC (the &#8220;Company&#8221;) announced that, on January 8, 2016, the Company received approval from the United States Food and Drug Administration (&#8220;FDA&#8221;) for the Perceval Sutureless Heart Valve (&#8220;Perceval&#8221;).&#160;&#160;The approval is effective immediately, and the Company will begin commercial distribution of the device in the U.S. over the coming quarter.</font></div>

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<div style="MARGIN-LEFT: 0pt; DISPLAY: block; MARGIN-RIGHT: 0pt; TEXT-INDENT: 36pt" align="left"><font style="FONT-SIZE: 10pt; FONT-FAMILY: Times New Roman; DISPLAY: inline">A copy of the Company&#8217;s press release dated January 11, 2016 announcing the FDA approval of the Perceval is included in this filing as Exhibit 99.1.</font></div>

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<div style="MARGIN-LEFT: 0pt; DISPLAY: block; MARGIN-RIGHT: 0pt; TEXT-INDENT: 0pt" align="left"><font style="FONT-SIZE: 10pt; FONT-FAMILY: Times New Roman; DISPLAY: inline">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.</font></div>

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<div style="MARGIN-LEFT: 0pt; DISPLAY: block; MARGIN-RIGHT: 0pt; TEXT-INDENT: 0pt" align="left"><font style="FONT-SIZE: 10pt; FONT-FAMILY: Times New Roman; DISPLAY: inline">Date:&#160;&#160;January 11, 2016</font></div>
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<div style="MARGIN-LEFT: 0pt; DISPLAY: block; MARGIN-RIGHT: 0pt; TEXT-INDENT: 0pt" align="left"><font style="FONT-SIZE: 10pt; FONT-FAMILY: Times New Roman; DISPLAY: inline">/s/ Brian Sheridan</font></div>
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<div style="MARGIN-LEFT: 0pt; DISPLAY: block; MARGIN-RIGHT: 0pt; TEXT-INDENT: 0pt" align="left"><font style="FONT-SIZE: 10pt; FONT-FAMILY: Times New Roman; DISPLAY: inline">Press Release issued by LivaNova PLC dated January 11, 2016</font></div>
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<TYPE>EX-99.1
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<DESCRIPTION>PRESS RELEASE OF LIVANOVA PLC DATED JANUARY 11, 2016
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<div style="MARGIN-LEFT: 0pt; DISPLAY: block; MARGIN-RIGHT: 0pt; TEXT-INDENT: 0pt" align="justify"><font style="FONT-SIZE: 10pt; FONT-FAMILY: Times New Roman; DISPLAY: inline"><img src="livn_logo.jpg" alt="LivaNova"></font></div>

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<div style="MARGIN-LEFT: 0pt; DISPLAY: block; MARGIN-RIGHT: 0pt; TEXT-INDENT: 0pt" align="right"><font style="FONT-SIZE: 10pt; FONT-FAMILY: Times New Roman; DISPLAY: inline">PRESS RELEASE</font></div>

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<div style="MARGIN-LEFT: 0pt; DISPLAY: block; MARGIN-RIGHT: 0pt; TEXT-INDENT: 0pt" align="left"><font style="FONT-SIZE: 12pt; FONT-FAMILY: Times New Roman; DISPLAY: inline">LivaNova PLC Announces Approval of Perceval</font></div>

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<div style="MARGIN-LEFT: 0pt; DISPLAY: block; MARGIN-RIGHT: 0pt; TEXT-INDENT: 0pt" align="justify"><font style="FONT-SIZE: 10pt; FONT-FAMILY: Times New Roman; DISPLAY: inline">LONDON, January 11, 2016 -- LivaNova PLC (NASDAQ:LIVN) (LSE:LIVN) (the &#8220;Company&#8221;) announced that, on January 8, 2016, the Company received approval from the United States Food and Drug Administration (&#8220;FDA&#8221;) for the Perceval Sutureless Heart Valve (&#8220;Perceval&#8221;).&#160;&#160;The approval is effective immediately, and the Company will begin commercial distribution of the device in the U.S. over the coming quarter.</font></div>

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<div style="MARGIN-LEFT: 0pt; DISPLAY: block; MARGIN-RIGHT: 0pt; TEXT-INDENT: 0pt" align="justify"><font style="FONT-SIZE: 10pt; FONT-FAMILY: Times New Roman; DISPLAY: inline">Perceval is a surgical aortic valve with a unique self-anchoring frame that enables the surgeon to replace the diseased valve without suturing it into place. The valve&#8217;s functional component is made of bovine pericardium and is mounted on a super-elastic alloy frame. Clinical results in patients implanted with Perceval have shown a significant reduction in surgical procedural time for both isolated and complex aortic valve replacement with aortic cross-clamp times typically reduced by at least 50%.</font></div>

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<div style="MARGIN-LEFT: 0pt; DISPLAY: block; MARGIN-RIGHT: 0pt; TEXT-INDENT: 0pt" align="justify"><font style="FONT-SIZE: 10pt; FONT-FAMILY: Times New Roman; DISPLAY: inline">&#8220;We are excited to bring this important product to the U.S. market,<font style="FONT-FAMILY: Times New Roman; DISPLAY: inline">&#160;</font>which will provide real value to patients and physicians,&#8221; said Andr&#233;-Michel Ballester, Chief Executive Officer.&#160;&#160;&#8220;The rapid acceptance of Perceval in Europe, an increasing number of positive publications on the product, and the solid preparation of our U.S. sales team, all provide a strong base for the achievement of our short and long term plans,&#8221; concluded Mr. Ballester.</font></div>

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<div style="MARGIN-LEFT: 0pt; DISPLAY: block; MARGIN-RIGHT: 0pt; TEXT-INDENT: 0pt" align="justify"><font style="FONT-SIZE: 10pt; FONT-FAMILY: Times New Roman; DISPLAY: inline">Perceval is indicated for the replacement of diseased, damaged, or malfunctioning native or prosthetic aortic valves.&#160;&#160;The sale and distribution of the Perceval heart valve is limited to prescription use by specially-trained practitioners, and the Company has developed a nationwide training and proctoring program to help ensure the safety and effectiveness of the device.</font></div>

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<div style="MARGIN-LEFT: 0pt; DISPLAY: block; MARGIN-RIGHT: 0pt; TEXT-INDENT: 0pt" align="justify"><font style="FONT-SIZE: 10pt; FONT-FAMILY: Times New Roman; FONT-WEIGHT: bold; DISPLAY: inline">About LivaNova</font></div>

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<div style="MARGIN-LEFT: 0pt; DISPLAY: block; MARGIN-RIGHT: 0pt; TEXT-INDENT: 0pt" align="justify"><font style="FONT-SIZE: 10pt; FONT-FAMILY: Times New Roman; DISPLAY: inline">LivaNova PLC, headquartered in London, UK, is a global medical technology company formed by the merger of Sorin S.p.A, a leader in the treatment of cardiovascular diseases, and Cyberonics Inc., a medical device company with core expertise in neuromodulation. LivaNova transforms medical innovation into meaningful solutions for the benefit of patients, healthcare professionals, and healthcare systems.&#160;&#160;The company employs approximately 4,500 employees worldwide. With a presence in more than 100 countries, LivaNova operates as three business units: Cardiac Rhythm Management, Cardiac Surgery, and Neuromodulation, with operating headquarters in Clamart (France), Mirandola (Italy) and Houston (U.S.A.), respectively.</font></div>

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<div style="MARGIN-LEFT: 0pt; DISPLAY: block; MARGIN-RIGHT: 0pt; TEXT-INDENT: 0pt" align="justify"><font style="FONT-SIZE: 10pt; FONT-FAMILY: Times New Roman; DISPLAY: inline">LivaNova is listed on NASDAQ and listed on the Official List of the UK&#8217;s Financial Conduct Authority and traded on London Stock Exchange (LSE) under the ticker symbol &#8220;LIVN&#8221;.</font></div>

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<div style="MARGIN-LEFT: 0pt; DISPLAY: block; MARGIN-RIGHT: 0pt; TEXT-INDENT: 0pt" align="justify"><font style="FONT-SIZE: 10pt; FONT-FAMILY: Times New Roman; DISPLAY: inline">For more information, please visit <font style="TEXT-DECORATION: underline; DISPLAY: inline">www.livanova.com</font>, or contact:</font></div>

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<div style="MARGIN-LEFT: 0pt; DISPLAY: block; MARGIN-RIGHT: 0pt; TEXT-INDENT: 0pt" align="justify"><font style="FONT-SIZE: 10pt; FONT-FAMILY: times new roman; FONT-WEIGHT: bold; DISPLAY: inline">Greg Browne</font></div>

<div style="MARGIN-LEFT: 0pt; DISPLAY: block; MARGIN-RIGHT: 0pt; TEXT-INDENT: 0pt" align="left"><font style="FONT-SIZE: 10pt; FONT-FAMILY: times new roman; DISPLAY: inline">Senior Vice President, Finance</font></div>

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