LivaNova Receives Regulatory Approval in Japan for KORA 250
Date: 28.1.2016
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 configuration 1 . 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 Disease 2 , while extending longevity by 2 years 3 . 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 apnea 5 . Recent studies have highlighted the risks of sleep apnea, a significant co-morbidity associated with atrial fibrillation and heart failure 6 , 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."
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.
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Source: LivaNova plc via GlobeNewswire
