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LivaNova plc: LivaNova Receives Regulatory Approval in Japan for KORA 250



(LSE:LIVN) (the "Company"), a leading global medical technology company,
announced today the approval of its new generation of full body MRI (Magnetic
Resonance Imaging) conditional pacemakers by PMDA in Japan. KORA 250 SR and
DR pacemakers allow patients to undergo MRI scans on any region of the body.

KORA 250 also features the unique Automatic MRI Mode which makes MRI scans
safe for pacemaker patients, automatically detecting the MRI scanner's
magnetic field and ensuring appropriate pacemaker operation during the scan.
After the scan, the device automatically returns to its initial
configuration1. As a result, unlike other pacing systems, KORA 250 minimizes
the amount of time that patients experience MRI mode.

Designed to proactively manage co-morbidities, KORA 250, at only 8cc, offers
advanced therapeutic and diagnostic features including:


the only algorithm proven to safely reduce unnecessary right ventricular
pacing for patients with Atrio-Ventricular block as well as Sinus Node
Disease2, while extending longevity by 2 years3. SafeR has also been shown
to reduce the risk of heart failure and cardiac hospitalization by 51% and
the risk of the first onset of atrial fibrillation by 23%4.

Sleep Apnea Monitoring


a clinically validated tool to efficiently screen and monitor patients for
severe sleep apnea5. Recent studies have highlighted the risks of sleep
apnea, a significant co-morbidity associated with atrial fibrillation and
heart failure6,7,8.

"In collaboration with our established business partner, Japan Lifeline, we
are proud to launch our latest generation of full-body MRI conditional
pacemakers in Japan where there is a strong demand for MRI compatible medical
devices. KORA 250, with its combination of small size, extended longevity and
therapeutic solutions, is an ideal solution for Japanese patients and
physicians. With this latest launch, LivaNova is aiming to set a new
standard in pacing technology in the Japanese market," said Stefano Di Lullo,
President, CRM Business Unit.

About LivaNova

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 aims to transform medical
innovation into meaningful solutions for the benefit of patients, healthcare
professionals, and healthcare systems. 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.

LivaNova is listed on the NASDAQ stock exchange and London Stock Exchange
(LSE), under the ticker symbol "LIVN."

Safe harbor statement
This press release contains forward-looking statements within the meaning of
Section 27A of the Securities Act of 1933, as amended and Section 21E of the
Securities Exchange Act of 1934, as amended. These statements can be
identified by the use of forward-looking terminology, including "may,"
"believe," "will," "expect," "anticipate," "estimate," "plan," "intend,"
"forecast," or other similar words. Statements contained in this press
release are based on information presently available to LivaNova and
assumptions that the parties believe to be reasonable. LivaNova is not
assuming any duty to update this information if those facts change or if the
assumptions are no longer believed to be reasonable. Investors are cautioned
that all such statements involve risks and uncertainties, including without
limitation, statements concerning developing novel opportunities in heart
failure, sleep apnea and percutaneous mitral valve, creating new innovative
solutions that benefit patients, healthcare professionals, and healthcare
systems, and building significant shareholder value. Important factors that
may cause actual results to differ include, but are not limited to: risks
that the new businesses will not be integrated successfully or that the
combined companies will not realize estimated cost savings, value of certain
tax assets, synergies and growth, or that such benefits may take longer to
realize than expected; the inability of LivaNova to meet expectations
regarding the timing, completion and accounting and tax treatments; risks
relating to unanticipated costs of integration, including operating costs,
customer loss or business disruption being greater than expected; reductions
in customer spending, a slowdown in customer payments and changes in customer
demand for products and services; unanticipated changes relating to
competitive factors in the industries in which the company operates; the
ability to hire and retain key personnel; the ability to attract new
customers and retain existing customers in the manner anticipated; reliance
on and integration of information technology systems; changes in legislation
or governmental regulations affecting the company; international, national or
local economic, social or political conditions that could adversely affect
the company or its customers; conditions in the credit markets; risks to the
industries in which LivaNova operates that are described in the "Risk
Factors" section of the Annual Reports on Form 10-K, Quarterly Reports on
Form 10-Q and other documents filed from time to time with the SEC by
Cyberonics, Inc. and LivaNova and the analogous section in annual reports and
other documents filed from time to time by Sorin S.p.A. with the Italian
financial market regulator (CONSOB); risks associated with assumptions made
in connection with critical accounting estimates and legal proceedings;
LivaNova's' international operations, which are subject to the risks of
currency fluctuations and foreign exchange controls; and the potential of
international unrest, economic downturn or effects of currencies, tax
assessments, tax adjustments, anticipated tax rates, raw material costs or
availability, benefit or retirement plan costs, or other regulatory
compliance costs. The foregoing list of factors is not exhaustive. You
should carefully consider the foregoing factors and the other risks and
uncertainties that affect the parties' businesses, including those described
in Cyberonics' Annual Report on Form 10-K, as amended from time to time,
Quarterly Reports on Form 10-Q, Current Reports on Form 8-K and other
documents filed from time to time with the SEC by Cyberonics and LivaNova and
those described in Sorin's annual reports, registration documents and other
documents filed from time to time with CONSOB by Sorin. LivaNova does not
give any assurance (1) that LivaNova will achieve its expectations, or (2)
concerning any result or the timing thereof, in each case, with respect to
any regulatory action, administrative proceedings, government investigations,
litigation, warning letters, consent decree, cost reductions, business
strategies, earnings or revenue trends or future financial results.

For more information, please visit www.livanova.com, or contact:

| Investor Relations: Investor Relations and Media: |
| |
| |
| |
|Vivid Sehgal Greg Browne |
| |
| |
| |
| Senior Vice President, Finance |
|Chief Financial Officer Phone: +1 (281) 228-7262 |
|e-mail: investor.relations@livanova.com Fax: +1 (281) 218-9332 |
| e-mail: corporate.communications@livanova.com |
1 KORA 250 MRI solutions manual (U641 KORA 250) available at

2 Stockburger M et al. Longterm clinical effects of ventricular pacing
reduction with a changeover mode to minimize ventricular pacing in general
population (ANSWER study). Eur Heart J.2015; 36 (3): 151-157.

3 Stockburger M et al. Safety and efficiency of ventricular pacing prevention
with an A AI-DDD changeover mode in patients with sinus node disease or
atrioventricular block: impact on battery longevity-a sub-study of the ANSWER
trial. Europace, 2015.

4 Boveda S et al. Minimized ventricular pacing to prevent the first onset of
AF in pacemaker patients without atrial arrhythmia history: results from the
ANSWER study, Europace Abstracts Supplement. ( 2015 ) 17 ( Supplement 3 ),

5 Defaye P et al. A pacemaker transthoracic impedance sensor with an advanced
algorithm to identify severe sleep apnea: The DREAM European study. Heart
Rhythm. 2014; 11: 842-8.

6 Lee W et al. Epidemiology of Obstructive Sleep Apnea: a Population-based
Perspective. Expert Rev Respir Med. 2008; 2(3): 349-364.

7 Gottlieb DJ et al. Prospective study of obstructive sleep apnea and incident
coronary heart disease and heart failure: the sleep heart health study.
Circulation. 2010; 122(4): 352-60.

8 Mehra R et al. Association of nocturnal arrhythmias with sleep-disordered
breathing: The Sleep Heart Health Study. Am J Respir Crit Care Med. 2006;
173(8): 910-6.


This announcement is distributed by NASDAQ OMX Corporate Solutions on behalf of NASDAQ OMX Corporate Solutions clients.
The issuer of this announcement warrants that they are solely responsible for the content, accuracy and originality of the information contained therein.
Source: LivaNova plc via Globenewswire


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