Medtronic has received regulatory approval from the Japan's Pharmaceuticals and Medical Device Agency (PMDA) for its Micra Transcatheter Pacing System (TPS).
Micra TPS is a leadless pacemaker, which is attach ed to the heart with small tines and provides electrical impulses that pace the vital organ through an electrode at the end of the device.
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Approval was based on the positive results from the single-arm, multi-centre Medtronic Micra TPS global clinical trial that assessed the safety and efficacy of the device in 744 patients at 56 centres in 19 countries.
It was found from the preliminary results of the trial that the device was implanted successfully in 99.2% of patients and has met the safety and efficacy endpoints.
Medtronic senior vice-president John Liddicoat said: "Medtronic is excited to be the first to offer a miniaturised, leadless pacemaker to patients in Japan.
"We look forward to working with Japan's Ministry of Health, Labor and Welfare to gain reimbursement for Micra so patients can gain access to this innovative technology as quickly as possible."
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By GlobalDataDesigned to be left in the body, Micra features a retrieval design and can be permanently turned off during the implantation of a new device, eliminating the risk of electrical interaction.
In April last year, Micra TPS was approved by the US Food and Drug Administration (FDA) as a single-chamber pacemaker for both 1.5 and 3 Tesla full-body magnetic resonance imaging (MRI) scans.
Medtronic is a medical technology, services and solutions company that offers technology for interventional and surgical treatment of cardiovascular disease and cardiac arrhythmias.
Image: The world headquarters of Medtronic, Fridley, Minnesota, US. Photo: courtesy of Bobak Ha'Eri/Wikipedia.
