Medtronic's Global First-in-Class Aurora EV-ICD Launches in China with Successful First Implant

Recently, according to the news released by the Lecheng Pilot Zone Administration, a team led by Professor Tang Baopeng, the vice president of the First Affiliated Hospital of Xinjiang Medical University, successfully completedChina's First Clinical Application of the Extravascular Implantable Cardioverter Defibrillator Aurora EV-ICD™。

It is reported that this extravascular implantable cardioverter defibrillator, Aurora EV-ICD™From Medtronic, an international medical device giant, which received FDA approval in October last year, isThe World's FirstAn extravascular ICD that can provide complete defibrillation, cardioversion, and anti-tachycardia pacing therapy for patients with sudden cardiac death (SCD).

Due to the sudden onset of cardiac sudden death and the difficulty in obtaining timely rescue, the survival rate is often extremely low. The advent of defibrillators has given humanity a chance to save lives when facing the "grim reaper," especially with the implantable cardioverter-defibrillator (ICD).

ICD monitors the patient's heart rhythm for 24 hours, and once arrhythmias such as ventricular fibrillation or cardiac arrest occur, it can deliver an electric shock for defibrillation within 10 to 20 seconds., ensuring the effectiveness of sudden cardiac death prevention reaches 80%, gradually becoming the gold standard for preventing SCD., known as a portable "ambulance".

However, as clinical data continues to accumulate, although the safety and efficacy of the defibrillation function have been confirmed, the risks caused by lead damage and infection after surgery are gradually being magnified.

How to avoid infection after ICD surgery has become a key focus of industry exploration.

In this clinical battle, Medtronic, which holds half of the global cardiac rhythm management market, successfully broke through with its unparalleled technical advantages in the pacemaker field.Not only has it overcome the clinical challenge of lead infections associated with traditional ICDs, but it has also introduced the Aurora EV-ICD™, a vascular implantable cardioverter defibrillator that simultaneously offers defibrillation, epicardial pacing, and ATP treatment functions.。

Aurora EV-ICD™

Traditional transvenous ICDs typically implant the pulse generator between the pectoralis major and pectoralis minor muscles, with leads entering the right ventricle of the heart through the subclavian vein to detect electrocardiographic signals and identify arrhythmias.

The pulse generator of the EV-ICD is implanted subcutaneously near the mid-axillary line, with the defibrillation lead placed beneath the sternum and outside the heart and veins.Cleverly addressing certain complications associated with transvenous leads, such as vascular injury and vascular occlusion (vein narrowing, blockage, or compression), marks a significant innovative breakthrough in ICD technology.

And besides the change in the product implantation site, Medtronic has also made innovations in product design.Fully taking into account the patients' experience and financial burden.

Dr. Bradley Knight, Distinguished Professor of Cardiology, once stated:Aurora EV-ICD is a significant step forward in implantable defibrillator technology, enabling us to further advance safe and effective ICD technology.

It is worth mentioning that the completion of the first clinical application of Aurora EV-ICD in China is mainly due to the "Pilot First" policy in Lecheng, China.

Public information shows that in 2013, the State Council approved the establishment of Boao Lecheng International Medical Tourism Pilot Zone in Hainan. In 2018, the State Council further granted additional privileges to the medical institutions within the Lecheng Pilot Zone.Approval authority for the use of internationally innovative drugs and medical devices that have been marketed abroad but not yet in China。

Currently, 28 medical institutions have opened and are operating in Lecheng, exceeding400 Special Licensed Medical Devices Achieve "First Use in China" in LechengLecheng is gradually becoming a new approach and method for the reform of the national drug and medical device review and approval system, accelerating the accessibility of global innovative products in clinical use in China.

And as a global leading medical device giant, how could Medtronic miss such an opportunity?

In 2020, Medtronic, which had been eyeing the "huge cake" of China's medical market, targeted the policy high ground of Lecheng. It signed a "Strategic Cooperation Memorandum" with the Administration Bureau of Boao Lecheng International Medical Tourism Pilot Zone, establishing a comprehensive and in-depth strategic partnership in the fields of medical innovation and medical technology.

According to statistics,Currently, 10 cardiovascular products of Medtronic have been implemented in the Boao Lecheng Pilot Zone., including AFA Pro Cryoballoon Ablation System, Micra Leadless Pacemaker, Renal Artery Sympathetic Nerve Multi-Pole Radiofrequency Ablation Catheter System, etc.

Since entering the Chinese market in 1989, Medtronic has been developing in China for 30 years. Today, China has become the largest single market for Medtronic globally, outside of the U.S. market.In addition to accelerating the implementation of innovative products, in recent years, Medtronic has also made frequent moves to seek broader development in this fertile land.

In June 2023, Medtronic held the groundbreaking ceremony for its first production line in Lingang New Area, Shanghai, which will focus on the research, development, and industrialization of products related to cardiovascular diseases.

In March this year,The first product for heart disease therapy on this production line has successfully come off the line., which not only accelerates Medtronic's localization innovation pace in the Chinese market but also further promotes the quality development and enhancement of China's high-end medical device industry.

In addition, as an international medical device giant, Medtronic has also invested a large amount of resources in the path of clinical training empowerment.

Medtronic has established innovation centers in Shanghai and Chengdu. It is reported that these two centers are equipped with complete simulation training facilities, including operating rooms, catheter labs, etc., aiming to provide clinical physicians with a more realistic surgical training experience.Approximately 15,000 medical professionals can be trained annually on average.

It can be seen that, driven by multiple factors such as market expansion, technological innovation, and clinical empowerment, Medtronic has successfully created a distinctive development system tailored for China's clinical needs by taking advantage of national policies. It has built a localized medical ecosystem in China, encompassing research and development, production, and training.The debut of the world's first extravascular implantable cardioverter defibrillator also signifies that Medtronic's localization strategy will enter a new phase.

And returning to the ICD market in China, since ICD products incorporate highly sophisticated technologies such as electrocardiophysiology, biomedical engineering, integrated circuits, and wireless communication, they have always been the "technological peak" in the cardiac rhythm management (CRM) field.Currently, China is still in a blank state in this field and has not yet achieved a breakthrough from zero in domestic production.

A highly promising yet untapped "virgin land" has naturally attracted the coveting of many multinational medical device companies besides Medtronic, such as Boston Scientific, Abbott, and Biotronik, which have long been ahead in strategic layout.

With the entry of giants and the rise of domestically produced devices, it's not hard to see that ICDs are gradually becoming another hot field following cardiac pacemakers.

However, at the same time, the importance of quality issues with ICD products is gradually becoming apparent.

In the past two years, Medtronic, Boston Scientific, Abbott and others have encountered several serious Class I recalls on ICD products, which is undoubtedly a wake-up call for companies in China. While focusing on technological innovation, it is essential to pay high attention to product quality issues and strengthen quality management and development.Issue, ensuring the safety and effectiveness of ICD products are fully guaranteed.