Medtronic's Micra Transcatheter Leadless Pacemaker Officially Launched in China at CIIE 2019

Recently, at the Second China International Import Expo (hereinafter referred to as the “CIIE”), Medtronic announced the official launch in the Chinese market of the Micra transcatheter pacing system, hailed as the “world’s smallest pacemaker,” for clinical application inMinimally Invasive Surgical Treatment for Arrhythmia。 

The Micra is only the size of a vitamin capsule, representing a 93% reduction in volume compared to traditional pacemakers, and weighs just approximately 2 grams. This “capsule pacemaker” will be implanted into the hearts of patients with arrhythmia via a minimally invasive approach. With no leads and no subcutaneous pocket, it is virtually imperceptible to patients, serving as an “invisible guardian” of heart health.

Despite its compact size, Micra boasts robust battery longevity and innovative features such as compatibility with 1.5 T/3.0 T whole-body MRI scans, providing stable life-sustaining power for patients with arrhythmias.

The number of patients with arrhythmia in China exceeds 10 million. As China enters an aging society, the incidence of arrhythmia is rising rapidly. Arrhythmia imposes multiple physiological and economic burdens on patients and their families, while the growing patient population also presents significant challenges to the national healthcare system.

Bradycardia, a significant type of cardiac arrhythmia, is generally defined as a heart rate of fewer than 60 beats per minute. At this frequency, the heart may fail to deliver sufficient blood to the body’s organs during daily activities or normal exercise.

Cardiac pacemakers can help patients improve cardiac function, enabling the heart to pump blood rhythmically and ensuring adequate blood supply to major organs. After implantation of a cardiac pacemaker, symptoms such as dizziness, vertigo, and syncope will be significantly alleviated, leading to a marked improvement in postoperative quality of life.

Professor Huang Dejia from West China Hospital of Sichuan University, Chairman of the Chinese Society of Cardiac Electrophysiology and Pacing, stated: “Implantation of a cardiac pacemaker is the only effective treatment for irreversible bradycardia. The approaches to arrhythmia management in China have evolved through”From traditional pacemakers, to MRI-compatible pacemakers, and then to Bluetooth-enabled pacemakers, across different stages, today finally welcomed the world's smallest volume at the CIIELeadless Cardiac Pacemaker"Deployed for clinical application in China, this achievement has synchronized the level of medical technology with international peers. The number of arrhythmia patients benefiting from cardiac pacing therapy in China annually has increased by more than thirty-fold compared to three decades ago when the treatment was first introduced. Cutting-edge innovations and breakthroughs in pacing therapy have met the growing public demand for cardiovascular healthcare services, empowering us to confidently face the severe disease challenges of the future."

According to reports, the Micra leadless pacemaker epitomizes “minimally invasive,” a new trend in the future development of medical technology. The implantation procedure for the leadless pacemaker takes approximately 30 minutes, allowing patients to quickly resume normal activities after surgery and return to their daily work and life within an estimated two days.

Micra enables leadless pacing therapy; after implantation, it attaches to the inner wall of the heart and delivers electrical impulses to restore a healthy heart rhythm, providing a stable “source of power” for life.

Zhang Shu, a member of the National Committee of the Chinese People’s Political Consultative Conference (CPPCC), Chairman of the Cardiac Electrophysiology Professional Committee of the Chinese Medical Doctor Association, and Professor at Fuwai Hospital, Chinese Academy of Medical Sciences, emphasized: “As one of the first medical centers in China to explore the use of Micra, Fuwai Hospital, together with my role as the principal investigator for the pre-market study of Micra in China, allowed us to experience the superior performance of this disruptive innovative product at the earliest opportunity and witness the benefits it brings to patients with arrhythmias.”

Guided by the human-centric philosophy of “Technology for People,” Micra empowers medical technology by innovating surgical approaches, improving patient outcomes, and reducing overall treatment costs. Through multifaceted efforts, it achieves an organic balance between therapeutic accessibility and affordability, ushering in a new era of leadless pacing for arrhythmia treatment in China.

Furthermore, patients are particularly concerned about advancements in medical security. How to optimize patient benefits—the “last mile” of health insurance coverage—presents a challenge for all stakeholders moving forward. Appropriately enhancing the level of medical insurance coverage for cardiac pacemaker therapy among urban and rural residents will not only facilitate the adoption of innovative technologies but also provide higher-quality health protection for the vast population of patients with arrhythmias.

The recently issued "Healthy China Action (2019–2030)" explicitly states that deaths attributable to four major chronic non-communicable diseases, including cardiovascular and cerebrovascular diseases, account for 88% of all deaths, while the disease burden they impose constitutes over 70% of the total disease burden. In light of these prominent public health challenges facing the nation, it is imperative to implement effective interventions that shift the focus toward prevention and early detection. Therefore, leveraging technological innovation to invigorate the foundational aspects of healthcare may well be the key to breaking the current impasse in disease prevention and control.

As one of the “star exhibits” at Medtronic’s debut at the China International Import Expo (CIIE), the Micra leadless cardiac pacing system has garnered significant attention from both media and the public.

On June 11, 2019, Micra received approval for clinical application and was launched in the Chinese market after undergoing the review process of the National Medical Products Administration. Leveraging the platform of the Second China International Import Expo, Micra’s launch not only showcased Medtronic’s advanced medical technology and innovative capabilities but, more importantly, raised public awareness about cardiac pacing therapy—a key approach to treating arrhythmias. This is expected to have a positive impact on the market adoption of Micra, enabling more patients to benefit from advanced medical technologies in a timely manner.

Professor Zhang Shu added, “The China International Import Expo (CIIE) and relevant national policies have charted the course for the development of healthcare. As partners in the advancement of cardiac pacing therapy in China, we are delighted to see leading medical technology companies such as Medtronic actively fulfilling their corporate social responsibilities and working closely with the domestic medical community to promote progress in China’s pacing field. Moving forward, we hope to join forces with stakeholders from all sectors of society to expedite the implementation of the initial batch of Micra implantation procedures at major central hospitals across China, enabling patients to benefit from this ‘CIIE achievement’ as soon as possible.”

Mr. Lin Song, Vice President of Medtronic’s Cardiac and Vascular Business in Greater China, stated, “The China International Import Expo (CIIE) has not only provided Medtronic with a platform to introduce medical technologies and innovations to the public, but also fully demonstrated China’s strong demand for the latest medical technologies under the drive of the national ‘Healthy China’ strategy. The success of Micra at the CIIE is a prime example. We look forward to leveraging the second CIIE as an opportunity to continue introducing more advanced medical technologies, and to work hand in hand with our Chinese healthcare partners to bring more high-quality medical solutions to patients, alleviating suffering, restoring health, and extending lives.”

It is reported that seven hospitals, including Fuwai Hospital of the Chinese Academy of Medical Sciences, West China Hospital of Sichuan University, Ruijin Hospital Affiliated to Shanghai Jiao Tong University School of Medicine, Zhongshan Hospital Affiliated to Fudan University, Jiangsu Province People’s Hospital, Beijing Anzhen Hospital Affiliated to Capital Medical University, and The Second Affiliated Hospital of Zhejiang University School of Medicine, have served as clinical trial centers for the pre-market launch of Micra in China. These institutions have already implemented the clinical application of this minimally invasive procedure. Approximately 80 patients with bradycardia have benefited from the novel pacemaker therapy offered by Micra, demonstrating favorable postoperative recovery. As major medical centers across China complete physician training and other preparatory work, more patients with arrhythmias are expected to access this new minimally invasive surgical treatment option in the near future.