Updated on 1 February 2016
Tokyo: London-based medical technology company LivaNova PLC has received approval for its new generation of full body Magnetic Resonance Imaging (MRI) conditional pacemakers by PMDA in Japan.
KORA 250 SR and DR pacemakers allow patients to undergo MRI scans on any region of the body. It is claimed to be the world's smallest full body MRI conditional pacing system.
LivaNova indicates that its 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, says LivaNova.
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, while extending longevity by 2 years.
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%.
Sleep Apnea Monitoring (SAM), a clinically validated tool to efficiently screen and monitor patients for severe sleep apnea. Recent studies have highlighted the risks of sleep apnea, a significant co-morbidity associated with atrial fibrillation and heart failure.
"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.