Medtronic's First Global New Product

Approved for NMPA Marketing

Recently (June 6, 2025), according to the information on the official website of the National Medical Products Administration, it officially approvedMedtronicCompany'sExtravascular Implantable Cardioverter DefibrillatorInnovative Product Registration Application.

It is reported that the extravascular implantable cardioverter defibrillator, Aurora EV-ICD™, received FDA approval as early as October 2023.Currently available in nearly 30 countries worldwide, isThe world's first extravascular ICD product capable of providing complete defibrillation, cardioversion, and antitachycardia pacing therapy for patients with sudden cardiac death (SCD)., which is of pioneering significance in the field of cardiac disease treatment.

In June last year, thanks to the policy boost of China's Boao Lecheng "Pilot Program",Aurora EV-ICD™ Successfully Completes China's First Clinical Application Implant Surgery at Ruijin Hainan Hospital in Boao, Hainan, not only allowed patients in China to experience the benefits of this globally advanced technology ahead of time, but also laid a solid clinical foundation for the successful approval of this product.

At the same time, paired with the Aurora EV-ICD™Extravascular Implantable Cardioverter Defibrillator Leads and Extravascular Implantable Cardioverter Defibrillator Lead Introducers,It has also been approved by the NMPA for marketing in April this year.

The approval of this series of complementary products marks that Aurora EV-ICD™ will officially enter the Chinese market, bringing better, safer, and more comprehensive treatment options for SCD patients in China, and advancing the level of cardiac disease treatment in China to new heights.

ICD Technological Innovation

Aurora EV-ICD™: A New Chapter in Safe Therapy

Sudden Cardiac Death (SCD) is one of the most common causes of death in cardiovascular diseases.Implantable Cardioverter Defibrillator (ICD) is the gold standard for preventing SCD., known as a portable "ambulance," which monitors the patient's heart rhythm 24 hours a day and can deliver an electric shock for defibrillation within 10 to 20 seconds if arrhythmias such as ventricular fibrillation or cardiac arrest occur.Ensure the effectiveness of sudden cardiac death prevention reaches 80%.

It is no exaggeration to say that the advent of ICD has given humanity a fighting chance against the "grim reaper."

However, traditional transvenous ICDs usually implant the pulse generator between the patient's pectoralis major and pectoralis minor muscles, and deliver the lead into the right ventricle of the heart via the subclavian vein to achieve ECG signal detection and arrhythmia recognition.Due to the long-term contact of the leads with the heart and veins, serious complications such as vascular injury, occlusion, and blood infection may occur at any time., posing a significant threat to patients' health.

Based on this, Aurora EV-ICD™ choosesThe pulse generator is implanted subcutaneously near the mid-axillary line, and the defibrillation lead is placed beneath the sternum, outside the heart and veins., avoiding direct contact between the leads and the heart and veins, significantly reducing the risk of postoperative complications caused by lead damage and infection,A major innovative breakthrough in the ICD technology field.

Aurora EV-ICD™

Not only that, but the Aurora EV-ICD™ alsoFully considering the patient's experience and economic burden, striving to ensure treatment efficacy while also making the treatment more comfortable for patients to undergo.

Medtronic once published a prospective, multicenter, single-group, non-randomized, pre-market clinical study on the Aurora EV-ICD™ in The New England Journal of Medicine, recruiting 356 patients across 46 centers in 17 countries worldwide.The research results show:

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

Undoubtedly, the advent of Aurora EV-ICD has pointed out the technical direction for the development of ICD products, opening a new chapter in global SCD safety treatment.

Centralized Procurement Support, Domestic Breakthrough
The Next Big Hit in Heart Failure Management Ignites a Billion-Dollar Market!

In the field of cardiovascular treatment, rhythm management is undoubtedly a "blue ocean track" with enormous wealth potential. Medtronic, Abbott, and Boston Scientific, the three major giants in this field, have already reaped huge profits as early as 2022.Achieved a brilliant record of over 10 billion US dollars in revenue,Among them, Medtronic accounted for the majority, generating revenue of $5.783 billion (equivalent to 41.54 billion RMB).

Looking at the performance of products in the global cardiac rhythm management market, pacemakers are undoubtedly the "star product," with implantation volumes far exceeding those of ICDs. According to the MicroPort Cardiac Rhythm招股说明书, in 2021, there were 1.2673 million pacemaker implants globally, compared to only 294,400 ICD implants.

But even so,The market size of ICD is comparable to that of cardiac pacemakers.According to statistics, the global pacemaker market was $3.597 billion in 2021.The ICD market size has reached 3.384 billion US dollars (equivalent to over 24.3 billion RMB).

This data hides the huge market potential and commercial value of ICD.Expected to become the next blockbuster product in the field of rhythm management.

Focusing on the ICD market in China,According to the data from the "Report on Cardiovascular Diseases in China" released by the National Center for Cardiovascular Diseases, the incidence rate of sudden cardiac death in China is 41.84 per 100,000, with a total annual death toll of 544,000, ranking first in the world.，Preventing sudden cardiac death has always been a key focus of China's national health work.

However, the penetration rate of ICD therapy in China is still at a relatively low level. In 2021, the global number of ICD implantation surgeries reached 290,000, while in China, there were only 8,200 such procedures. This gap highlights the significant room for growth in China’s ICD market.

In recent years, as bulk procurement projects for ICDs and other pacemakers have been successively implemented in multiple provinces across China, the price of ICDs has significantly dropped, which has not only reduced the financial burden on patients,It also creates favorable conditions for the increase in sales and market penetration of related products.

It is worth mentioning that, with the support of numerous favorable policies, China-produced innovative medical device companies have achieved a historic leap from nothing to something in the high-end technology field of ICD.

In October 2024, Medtronic's PLATINIUM™ series ICD products were successfully approved for marketing by NMPA, becomingThe first domestically produced ICD approved for marketing in China.

In addition, the ICD independently developed by Wushuang Medical officially entered China's special review process for innovative medical devices in 2023, with performance indicators reaching basically international leading levels.Expected to be launched in 2026,Injects new vitality into the ICD market in China.

Obviously, for medical device distributors in China, the market is about to stage a thrilling "duel between two giants," whether it is Medtronic's world-first extravascular ICD, which boasts both brand influence and technological innovation, or the domestically produced ICDs that are rapidly gaining prominence driven by the volume increase from centralized procurement.Will become a "powerful tool" for dealers to tap into the billion-dollar equipment market!

At present, with the continuous advancement of ICD technology and the increasing attention to sudden cardiac death, the market is in a golden period of vigorous development, undoubtedly making it an excellent time to enter the industry. Dealer partners can not only leverage the superior products of Medtronic or domestically-produced ICDs to achieve rapid business growth and sustainable development, but also play a key role in promoting the development of China’s ICD market, contributing significantly to improving the health standards of the Chinese population.