Boao Super Hospital Completes China's First Clinical Implant of Next-Generation Leadless Pacemaker Micra AV

Boao, September 7, 2020 /PRNewswire/ -- Recently,Medtronic's Latest DevelopmentThe leadless dual-chamber pacemaker Micra AV successfully completed its first clinical application in China at Boao Super Hospital, located within the Boao Lecheng International Medical Tourism Pilot Zone. The newly introduced Micra AV leadless dual-chamber pacemaker not only retains the advantages of the first-generation Micra VR leadless pacemaker but also achieves a pacing pattern that more closely mimics the natural heartbeat through innovative sensor technology and breakthroughs in revolutionary algorithms. The "A" and "V" stand for atrium and ventricle, respectively, with "AV" indicating the capability for atrioventricular conduction, thereby better simulating the heart's physiological conduction function and delivering physiological, precise, and patient-tailored pacing.

Professor Zhang Shu, a member of the National Committee of the Chinese People's Political Consultative Conference, Chairman of the Heart Rhythm Specialty Committee of the Chinese Medical Doctor Association, and Chief Expert at the International Center for Cardiac Medicine at Boao Super Hospital, introduced that Micra AV is the next-generation innovative product of Micra VR, a star exhibit at the previous two China International Import Expos (CIIE). Micra VR debuted at the 2018 CIIE and was hailed by the media as “the world’s smallest pacemaker.” With the care and support from leaders at all levels in Hainan Province and the Boao Lecheng Pilot Zone, and through the active efforts of Boao Super Hospital, the first clinical application in China was successfully performed at Boao Super Hospital in December of that year. This achievement strengthened confidence in the application of this new technology among Chinese patients and ushered in a new era of leadless pacing therapy in China. This year, the cardiology team at Boao Super Hospital embarked on its mission once again to transform the landscape of pacing therapy in China, achieving the first clinical application of Micra AV in the country—another significant milestone in the development of pacing therapy in China. The clinical practice of Micra AV in Hainan aligns with the province’s policy of “pilot implementation” for global innovative medical devices and pharmaceuticals. Government departments at all levels in Hainan Province, particularly the Administration Bureau of the Pilot Zone, the Provincial Medical Products Administration, and the Provincial Health Commission, have provided strong support to advance the goal of synchronizing the application of innovative medical technologies from both domestic and international sources.

The Micra AV procedure was led by Professor Wu Liqun, Director of the Department of Cardiology at Ruijin Hospital affiliated with Shanghai Jiao Tong University, Deputy Chairman of the Electrophysiology and Pacing Branch of the Chinese Medical Association, and an expert at the International Heart Medical Center of Boao Super Hospital, together with Dr. Pan Wenqi and Dr. Ling Tianyou. “Under the new normal, the public and medical professionals have gained a better understanding of the greater healthcare conveniences that internationally synchronized medical technologies, such as Micra, can bring to ordinary people,” said Professor Wu Liqun.“The implanted Micra AV is the world’s first dual-chamber leadless pacemaker. Similar to its predecessor, the Micra VR, it is only the size of a vitamin capsule, weighs approximately 2 grams, and is compatible with 1.5 T/3.0 T whole-body MRI scans. Without the leads and subcutaneous pockets associated with traditional pacemakers, it enables rapid patient recovery and eliminates the sensation of a foreign body, thereby safeguarding cardiac health.‘Invisible Guardian’What sets this dual-chamber device apart is its revolutionary new algorithm, which enables ventricular sensing following atrial pacing to achieve sequential atrioventricular conduction, thereby benefiting a broader population of patients who meet the indications for pacemaker implantation. The procedure for this patient lasted only 30 minutes, and the postoperative condition was favorable; we anticipate a swift recovery and discharge, allowing the patient to return to an unrestricted lifestyle. Thanks to the open and inclusive policies of the Hainan Provincial Government, domestic patients can access this cutting-edge global technology ahead of schedule. We hope that Micra AV will be officially launched in China at the earliest opportunity, bringing benefits to a wide range of patients with arrhythmias.。”

Gu Gang, Secretary of the Party Committee and Director of the Administration Bureau of Boao Lecheng International Medical Tourism Pilot Zone in Hainan, stated, “In the future, the Lecheng Pilot Zone will continue to promote high-level opening-up and high-quality development, aligning medical technologies, equipment, and pharmaceuticals with international advanced standards.”‘Three Synchronizations’. Recanalization‘Clinically Urgent Need’The “Green Channel” has introduced the most advanced technologies in the current pacemaker industry to China, highlighting the Boao Lecheng International Medical Tourism Pilot Zone’s commitment to its original mission of “Unleashing Global Energy,” and further demonstrating the nation’s firm resolve to advance healthcare services in Hainan and across China. By actively benchmarking against international best practices and fostering a rule-of-law-based, internationalized, and convenient business environment, the zone collaborates with companies like Medtronic to provide a showcase platform for innovative international pharmaceuticals and medical devices not yet marketed in China. This enables patients to access cutting-edge treatments and devices on par with global standards without leaving the country, thereby establishing a new window for showcasing international innovative pharmaceuticals and medical devices in China.

As China’s population ages at an accelerating pace and COVID-19 prevention and control become normalized, public demand for healthcare services has risen sharply. Minimally invasive treatments such as the Micra leadless pacing therapy represent the future trend in medical technological development. Professor Fang Pihua, Executive Vice President of Boao Super Hospital, emphasized, “The leadless pacemaker implantation procedure takes only 30 minutes, with patients discharged within two days, significantly reducing the risk of hospital-acquired infections. During the fight against the COVID-19 pandemic, the benefits of minimally invasive surgery for patients have become even more pronounced. The advent of leadless pacing therapy has enabled numerous patients with arrhythmias to free themselves from the burden of disease and return to normal life.””If the first-generation Micra ushered in the era of leadless pacing therapy in China, then the new-generation Micra AV will continue to lead China’s pacing therapies to a higher level of precision treatment.

Professor Zhang Shu stated, “Leveraging the momentum of the ‘Nine National Measures’ policy, Boao Super Hospital has become a forefront gateway for introducing cutting-edge international medical devices, pharmaceuticals, and vaccines into China. It shoulders the mission of promoting the integration of China’s healthcare sector with global standards and is committed to building a world-class platform for medical technology innovation. We have never ceased our efforts to introduce innovative medical technologies to benefit patients. The priority introduction of Micra AV signifies that the International Heart Center at Boao Super Hospital remains steadfast in its goal of achieving ‘triple synchronization’ with advanced international levels in medical technology, equipment, and pharmaceuticals. In the face of challenges in the new era, the national stance on openness, cooperation, and win-win outcomes will remain unwavering. Looking ahead, we anticipate that an increasing number of globally leading innovative medical devices, such as Micra AV, which meet the healthcare demands of the new era, will be simultaneously applied in clinical practice at Boao Super Hospital, thereby contributing to the advancement of pacing therapy and other disease-related medical standards in China.””

Ms. Huang Fang, Vice President of Medtronic’s Cardiac Rhythm and Heart Failure Business for Greater China, stated, “As a global leader in medical technology, Medtronic is honored to once again partner with Boao Super Hospital to introduce numerous innovations aligned with international standards to China, thereby continuously contributing to the development of China’s healthcare sector. We recognize that we are at a historic juncture in healthcare reform, with the national government prioritizing public health as a strategic development priority. Looking ahead, Medtronic remains committed to its strategy of being rooted in and serving China. We will continue to fulfill our corporate social responsibility by introducing innovative global medical technologies, helping more Chinese patients alleviate suffering, restore health, and extend life.””