Release Details

KORA 250, combining small size, extended battery longevity and Automatic MRI Mode, is powered by intelligent algorithms designed to improve patient outcome.

Tokyo, JAPAN, March 22, 2016 - Japan Lifeline, LivaNova’s established business partner in Japan, has announced the first implant of the KORA 250 full body MRI pacemaker.

In combination with the Screwvine active fixation pacing lead, the first KORA 250 in Japan has been successfully implanted by Professor Y. Nakazato, Director of the Cardiology department at the Juntendo University Urayasu Hospital, Japan, in a 79-year-old patient with symptomatic bradyarrhythmias.

Professor Nakazato commented: "The small size and long-lasting battery of KORA 250 will be very much appreciated by my patients. Besides the full body MRI compatibility which is strongly required in Japan, I have chosen a pacemaker from the KORA 250 family because it offers algorithms like Sleep Apnea Monitoring and SafeR which allow me to effectively manage comorbidities and reduce long-term risk.”

KORA 250 is equipped with the unique Automatic MRI Mode which makes MRI scans safe for pacemaker patients enabling the automatic detection of the MRI scanner’s magnetic field. As a result, unlike other pacing systems, KORA 250 ensures that the patient will be paced in asynchronous mode for the least amount of time.

Professor Nakazato concluded “Our patients deserve the highest standard of care and I am very glad they can benefit from the latest and most advanced technical solutions.”

KORA 250 also features advanced therapeutic and diagnostic solutions including:

Sleep Apnea Monitoring (SAM), a clinically validated tool to efficiently screen and monitor patients for severe sleep apnea¹, a significant cardiovascular comorbidity associated with atrial fibrillation and heart failure.²,^3,4

SafeR, the only algorithm proven to safely manage patients with Atrio-Ventricular block, excessively long AV conduction times and Sinus Node Disease⁵. SafeR has 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%⁶. Moreover it extends the longevity of the pacemaker and reduces the need for device replacement⁷.

For further information, please click here: KORA 250.

1 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.

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

3 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.

4 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.

5 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.

6 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

7 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.