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February 20, 2017

Medtronic gains Japanese PMDA approval for Micra TPS

Medtronic has received regulatory approval from the Japan's Pharmaceuticals and Medical Device Agency (PMDA) for its Micra Transcatheter Pacing System (TPS).

Medtronic has received regulatory approval from the Japan's Pharmaceuticals and Medical Device Agency (PMDA) for its Micra Transcatheter Pacing System (TPS). 

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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.

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."

Designed 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.

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GlobalData's APAC Medical Devices Industry Landscape – 2022 free study breaks down the APAC medical devices market by segment and region and includes insights on local and global competitors, pipeline product developments, clinical trials studies, and significant deals in the industry. The APAC medical device industry witnessed significant developments, launches, implementations, and adoption of new medical device technologies in the past decade, however the high cost of devices, regulatory hurdles, reimbursement pressure, and healthcare budget constraints have challenged market expansion across various territories and segments. APAC is the fastest growing regional market for medical device clinical trials, with China and Japan emerging as major clinical trial hotspots. The growth in medical device clinical trials in the APAC region is attributed to an increase in research partnerships between biopharma companies and clinical research organizations (CROs). This report also provides an in-depth analysis of the medical device market's opportunities and challenges, the influence of COVID-19 on the market, and government activities aimed to develop the APAC medical device market.
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