Nasdaq GlobeNewswire

LivaNova Receives Regulatory Approval in Japan for KORA 250

Del

WORLD’S SMALLEST FULL BODY MRI CONDITIONAL PACING SYSTEM

WITH ITS UNIQUE COMBINATION OF SMALL SIZE, EXTENDED LONGEVITY, AND PROPRIETARY TECHNOLOGIES DESIGNED TO IMPROVE PATIENT OUTCOMES, KORA 250 ENABLES PATIENTS TO UNDERGO FULL BODY MRI SCANS

LONDON, Jan. 28, 2016 (GLOBE NEWSWIRE) -- LivaNova, PLC (NASDAQ:LIVN) (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:

SafeR, 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 (SAM), 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:
Vivid Sehgal 
Chief Financial Officer 
e-mail: investor.relations@livanova.com
Investor Relations and Media:
Greg Browne
Senior Vice President, Finance 
Phone: +1 (281) 228-7262
Fax: +1 (281) 218-9332
e-mail: corporate.communications@livanova.com


1 KORA 250 MRI solutions manual (U641 KORA 250) available at www.sorinmanuals.com

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 ), iii24

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.

Om Nasdaq GlobeNewswire

Nasdaq GlobeNewswire
Nasdaq GlobeNewswire
One Liberty Plaza - 165 Broadway
NY 10006 New York

+1 212 401 8700http://www.nasdaqomx.com

NASDAQ (NASDAQ: NDAQ) is a leading provider of trading, exchange technology, information and public company services across six continents.

Følg saker fra Nasdaq GlobeNewswire

Registrer deg med din epostadresse under for å få de nyeste sakene fra Nasdaq GlobeNewswire på epost fortløpende. Du kan melde deg av når som helst.

Siste saker fra Nasdaq GlobeNewswire

Tier1CRM Receives Significant Equity Capital to Accelerate Growth11.12.2017 23:28Pressemelding

Raises $34 Million (USD) from Leading Financial and Strategic Investors to Continue Building on Recent Successes TORONTO and NEW YORK, Dec. 11, 2017 (GLOBE NEWSWIRE) -- Tier1CRM (Tier1), a provider of cloud-based customer relationship management (CRM) solutions for the capital markets industry, announced today that it raised $34 million (USD) in growth equity financing from a group of investors led by Wavecrest Growth Partners, with participation from MassMutual Ventures and Salesforce Ventures. Founded in 2008 by Mark Notten and Phil Dias and based in Toronto, Tier1 is a leading provider of CRM and customer engagement SaaS solutions to sell-side and buy-side financial services clients spanning sales and trading desks, investment banks and investment managers. Major global financial institutions leverage the Tier1 platform to efficiently and more profitably manage client relationships, improve internal transparency and collaboration, manag

Minerva Neurosciences Names Richard Russell President11.12.2017 22:40Pressemelding

WALTHAM, Mass., Dec. 11, 2017 (GLOBE NEWSWIRE) -- Minerva Neurosciences, Inc. (NASDAQ:NERV), a clinical-stage biopharmaceutical company focused on the development of therapies to treat central nervous system (CNS) disorders, today announced the appointment of Rick Russell as President.  Dr. Remy Luthringer will continue as Chief Executive Officer of Minerva while resigning his position as President. Mr. Russell has more than 20 years of experience leading commercial operations, including developing and implementing sales and marketing activities for major biotechnology and pharmaceutical brands in North America and the European Union.  His experience encompasses several therapeutic areas, including CNS disorders, neurodegenerative disorders, cardiovascular disease and women's health. "We welcome Rick Russell to Minerva, where his wide-ranging commercial expertise will help ensure the effective transition from late-stage clinical development to the market for our product c

Sonoco-Alcore to Increase Paperboard Prices in Europe11.12.2017 22:30Pressemelding

BRUSSELS, Belgium, Dec. 11, 2017 (GLOBE NEWSWIRE) -- Sonoco-Alcore S.a.r.l. today announced it will again raise prices by a further €50 per tonne on all recycled paperboard grades sold in the Company's Central European regions. The price change is effective with shipments on or after the 1st January 2018. "The continued strong demand for core board across Europe, along with expectations that already elevated raw material and energy prices will continue to rise into the New Year, leave us little choice but to implement this increase," said Phil Woolley, Director - Paper Europe. Sonoco-Alcore S.a.r.l. is wholly-owned by Sonoco (NYSE:SON) and operates 29 tubes and cores plants and four paperboard mills in Europe. Contact: Roger Schrum +843/339-6018 roger.schrum@sonoco.com     This announcement is distributed by Nasdaq Corporate Solutions on behalf of Nasdaq Corpor

Minerva Neurosciences Elects William Doyle and Hans Peter Hasler to Board of Directors11.12.2017 14:15Pressemelding

WALTHAM, Mass., Dec. 11, 2017 (GLOBE NEWSWIRE) -- Minerva Neurosciences, Inc. (NASDAQ:NERV), a clinical-stage biopharmaceutical company focused on the development of therapies to treat central nervous system (CNS) disorders, today announced the election of William F. Doyle and Hans Peter Hasler to the Board of Directors of the Company. "Bill Doyle and Hans Peter Hasler bring distinguished leadership backgrounds and complementary sets of expertise to Minerva's Board of Directors," said Dr. Fouzia Laghrissi-Thode, Board member and chairperson of the search committee at Minerva.  "Their bio-pharma industry-specific experience, which encompasses strategic development, partnering, licensing, product launches, marketing and commercialization, will benefit Minerva as the foundation is laid for the commercialization of the Company's products currently in advanced clinical development.  We look forward to Bill's and Hans's entrepreneurial and operational perspectives on how Minerva can b

Sabina Gold & Silver Announces Commencement of the Review of its Water License Applications for the Back River Project11.12.2017 13:30Pressemelding

VANCOUVER, British Columbia, Dec. 11, 2017 (GLOBE NEWSWIRE) -- Sabina Gold & Silver Corp (TSX:SBB.T), ("Sabina" or the "Company") is pleased to announce that the Nunavut Water Board (NWB) has commenced public review of the Type A and Type B water license applications related to initial development, mine construction and operation of the Back River Project (the "Project" or "Back River"). As announced on December 6, 2017, the Minister of Indigenous and Northern Affairs Canada, on behalf of the five responsible federal Ministers, accepted Nunavut Impact Review Board's recommendation for the Project to proceed to the regulatory and licensing phase.  The NIRB has advised that the final Project Certificate will be issued on or before January 4, 2018. The Type B water license would enable Sabina to commence certain initial pre-development activities in 2018 including onsite construction of service roads and laydown pads, and the mobilization of fuel, supplies and equipment at t

Standard Lithium Provides Development Update on California Lithium Project11.12.2017 11:00Pressemelding

VANCOUVER, British Columbia, Dec. 11, 2017 (GLOBE NEWSWIRE) -- Standard Lithium Ltd. ("Standard Lithium" or the "Company") (TSX-V:SLL) (FRA:S5L) (OTCQX:STLHF) is pleased to provide an update on the development work taking place at the Company's California Lithium Project; comprising the Bristol Dry Lake and the Cadiz Dry Lake lithium brine properties located in the Mojave Desert, California. A total of six new separate evaporation ponds have been installed on the Bristol Dry Lake Property to further assess the role that short-duration passive solar evaporation may play in processing the lithium brines encountered at the project.  Previous work demonstrated that, owing to extremely high evaporation rates in the project area, it is possible to concentrate brines from initial lithium concentrations of 146 mg/L to concentrations of 686 mg/L in approximately 7 weeks (note, this average lithium concentration was previously reported as 556 mg/L in news release dated 10th Oct 2017,

I vårt presserom finner du alle våre siste saker, kontaktpersoner, bilder, dokumenter og annen relevant informasjon om oss.

Besøk vårt presserom