Ames Gross, Pacific Bridge Medical
Ameing for Asia

Cutting-Edge Atrial Fibrillation Devices Revitalize Japanese Market

By Ames Gross
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Ames Gross, Pacific Bridge Medical

MRI-compatible pacemakers are among the technologies gaining traction.

Atrial fibrillation (AF), a life threatening heart disorder, is on the rise among Japan’s aging population, providing opportunities for manufacturers of innovative devices that aim to manage and treat the irregular, rapid heart palpitations characteristic of the condition. Makers and distributors of a range of medical devices have responded to the growing need, introducing a new generation of treatment options over the past two years to a market that had plateaued.

The newly promising market in Japan for devices and technologies to manage and treat atrial fibrillation mirrors the same trend around the world. Globally, the atrial fibrillation market is forecast to grow at a combined annual growth rate of 4.5% per year. In the major markets of the United States, France, Germany, Italy, Spain, Great Britain, Japan and Canada, combined sales of AF-related devices are projected to hit $12 billion in 2022.

Atrial Fibrillation Increasingly Widespread in Japan

Triggered by abnormal electrical signals in the upper chambers of the heart, atrial fibrillation causes a quivering, unsteady heartbeat. Untreated, atrial fibrillation doubles the risk of heart-related death and increases a person’s chance of having a stroke fivefold.

According to the American College of Cardiology, which teamed up with Japanese researchers to study the disorder last year, AF afflicts more than 800,000 Japanese, most over the age of 65. By 2020, 1 million Japanese, or 1.1% of the nation’s population, will be living with atrial fibrillation.

Medications are typically the first-line treatment for the condition. Anti-arrhythmic medicines can be used to restore and maintain a normal heart rhythm. Blood thinners, also called anticoagulants, are often prescribed to prevent blood clots associated with atrial fibrillation. But for many patients, drug therapies are ineffective or cause negative side effects. Alternatives include electrical cardioversion, radiofrequency catheter ablation and pacemakers.

Traditional pacemakers have been on the market in various forms for decades. What is revolutionizing the market for the devices in Japan is the growing presence of the increasingly popular magnetic resonance imaging (MRI)-compatible variety. Unlike traditional pacemakers, MRI-compatible pacemakers have built-in safeguards to block magnetic and radio waves emitted during magnetic resonance imaging. The new pacemaker devices allow patients to undergo MR imaging exams without harm to the device or changes to the device settings.

Foreign Manufacturers Big Players in Japan’s MRI-Compatible Pacemaker Market

Six years ago, in 2012, medical device manufacturer Medtronic (Minneapolis, Minnesota) launched the first MRI-compatible pacemaker in Japan. Others followed, among them Berlin, Germany-based Biotronik, Inc. and Italian device maker Sorin Group. Since then, the devices have been adopted faster in Japan than in any other country. Indeed, the sale of MRI-compatible pacemakers in Japan reaped device manufacturers more than $80 million in revenue between 2013 and 2015. The market for the pacemakers is expected to continue growing at a compound growth rate of 13% through the end of 2019.

The popularity of MRI-compatible pacemakers in Japan is driven by two factors: An aging population, and the widespread and frequent use of MRIs. In Japan, a majority of people over age 65 undergo at least one MRI scan per year to diagnose potential medical conditions. There are more MRI scanners per million population in Japan than anywhere else in the world.

Biotronik introduced Edora, a new, smaller, more fully automated MRI-compatible pacemaker in Japan in January 2017, five months before it was launched on the U.S. market. One month later, competitor Medtronic began sales in Japan of an even smaller device, the Micra, a miniature pill-sized pacemaker placed directly inside the heart.

Japan Lifeline, a Tokyo-based medtech distributor, followed suit, launching an MRI-compatible pacemaker manufactured by LivaNova (London, UK). The pacemaker, the KORA 250, grew sales of pacemakers distributed by Lifeline by 9% in fiscal 2017 over the previous fiscal year.

Catheter Ablation and Cardioversion Device Market Also Experience Growth in Japan

Cardiac ablation involves using radio frequency energy, extreme cold, or heat to make small scars in heart tissue. The scars can stop abnormal electrical signals from causing the organ to beat irregularly.

Catheter ablation technologies are increasingly in use in Japan, and manufacturers of a range of devices that aim to de-activate the errant electrical signals that cause AF are moving rapidly into the market. Overall, sales for ablation systems in Japan grew 16% in fiscal 2017.

In 2016, St. Jude Medical, Inc. (St. Paul, Minnesota) introduced a new cardiac ablation device, the TactiCath Quartz Irrigated Ablation Catheter, in Japan, after it was approved by the Japan’s Ministry of Health, Labor and Welfare. St. Jude Medical also produces an MRI-compatible implantable cardioverter defibrillator device, called Ellipse, that delivers electrical shocks to the heart to control life-threatening arrhythmias. It has already been on the market in Japan since March 2016.

In January, medical device maker CardioFocus, Inc. (Marlborough, Massachusetts) announced a partnership with Japan Lifeline Co, Ltd., a Japanese distributor, to sell their balloon ablation catheter technology in Japan. The catheter, the HeartLight X3 System, uses an inflatable balloon and targeted laser energy to ablate, or destroy, a large area of tissue. The system is scheduled to be distributed in Japan this summer.

Meanwhile, Medtronic plans to enter the market soon with its Arctic Front Advance Cardiac Cryoballoon Catheter. The company has released a clinical study finding that the system reduced complications and slowed the rate of repeat cardiac ablation procedures by 33% compared to radiofrequency ablation.

The Japanese market for cardiac rhythm management devices, including pacemakers and ablation systems, is a mature market. Until recently, it had experienced very little new growth. But in the last two to three years, new technologies have revitalized the market. As Japan’s population continues to age, this new generation of atrial fibrillation devices—smaller, safer for use with MR imaging machines, and easier to use effectively—is projected for continued growth.

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