Medtronic's Aurora EV-ICD Receives NMPA Approval as World’s First Extravascular Implantable Cardioverter Defibrillator

Recently, the National Medical Products Administration approved the registration application for Medtronic's innovative extravascular implantable cardioverter defibrillator.

Source of the image: NMPA official website

The World's First
Innovative Therapies Launched in China

The vascular extraneous implantable cardioverter defibrillator approved for marketing this time —— Aurora EV-ICD is another breakthrough innovative product by Medtronic. According to the introduction on the NMPA official website, this product consists of an implantable cardioverter defibrillator and a torque wrench, forming a vascular extraneous implantable cardioverter defibrillation system when combined with vascular extraneous implantable cardiac defibrillation electrode leads.

Image Source: Medtronic

It is worth mentioning that this product features a groundbreaking design concept, distinct from traditional ICD products. The Aurora EV-ICD is placed beneath the sternum, allowing the lead to entirely avoid the heart and vascular system. This design also fundamentally alters the traditional pathway approach of ICD technology that has been followed for many years. Traditional transvenous ICDs (TV-ICDs), which involve implanting leads into the right ventricle of the heart via the subclavian vein, come with significant risks—vascular damage, occlusion, infections, and other complications that loom over patients like the Sword of Damocles. In contrast, the Aurora EV-ICD, based on this innovative design, avoids some of the risks associated with traditional TV-ICDs, such as vascular injuries and bloodstream infections.

In addition, Aurora EV-ICD also has multiple advantages:

With a volume of only 33 cubic centimeters, it can deliver up to 40 joules of current;

Antitachycardia Pacing (ATP), which terminates ventricular arrhythmias with low-energy pulses, avoiding the painful effects of high-energy shocks;

Its lead adopts a unique "ε-shaped lead" structure, which includes 2 pacing/sensing electrodes and 2 defibrillation coil segments (each 4 cm), bound together to form an 8 cm overall defibrillation coil, ensuring precise sensing and efficient treatment of arrhythmias.

With an ultra-long lifespan of 11.7 years, extending the replacement cycle by 60% compared to similar devices;

Can meet the clinical MRI examination needs of patients at 1.5T and 3.0T field strengths, solving the imaging examination challenges for patients with implants.

In the EV ICD Pivotal study published by Medtronic, the product's efficacy and safety exceeded expected key outcomes. Moreover, in June 2024, thanks to the "pilot first" policy in Boao Lecheng Pilot Zone in Hainan, China completed its first extravenous implantable cardioverter-defibrillator (EV-ICD) surgery. The patient recovered well post-surgery, validating the safety of EV-ICD in the Asian population.

Currently, Aurora EV-ICD has obtained the EU CE certification in August 2023 and the US FDA certification in October 2023. Moreover, its accompanying products: extravascular implantable cardioverter-defibrillator leads and extravascular implantable cardioverter-defibrillator lead introducers, have passed the innovative product registration application of NMPA on April 17 this year.

Import ratio 92.31%
The Process of Domestic Substitution Needs to Be Accelerated

According to public data, in China, sudden cardiac death claims more than 540,000 lives each year, with less than 1% success rate for out-of-hospital resuscitation. This fatal condition, often triggered by ventricular tachycardia or ventricular fibrillation, frequently occurs without any warning. Currently, ICDs are the "mainstay" treatment for sudden cardiac death.

Based on the large patient population, increasing health awareness, and continuously advancing technological levels, the market share of implantable cardioverter defibrillators is further expanding, with the potential to reach a market size of approximately 3 billion by 2030.

However, at present, due to the late start of ICD enterprises in China, the Chinese ICD market has long been dominated by foreign brands. Medtronic occupies nearly 50% of the market share, followed closely by overseas giants such as Abbott, Boston Scientific, and Biotronik. Technical barriers have once become an insurmountable mountain for domestic companies.

Fortunately, in recent years, China's technological level has been increasing, and innovative medical device companies that have already laid out ICD products are taking the lead. In 2024, CH pacemaker Medical’s PLATINIUM™ series of Implantable Cardioverter Defibrillators (ICD) were approved for marketing, becoming the first Chinese-produced ICD product to be approved in China. This approval includes two models: the dual-chamber PLATINIUM DR 1540 (with an expected service life of over 13 years) and the single-chamber PLATINIUM VR 1240 (with an expected service life of over 14 years).

According to the Pharma Intelligence medical device data query, 14 ICD products have been approved for marketing in China. However, among them, only one ICD product from Chuangling Cardiac Rhythm Management is domestically produced. Currently, imported products hold an absolute advantage of 92.31%, while domestically produced ones account for only 7.69%.

Image Source: PharmCube Medical Device Data

Currently, the approval of Aurora EV-ICD™ has cast a stone into China's vast ICD market. On one hand, it reinforces the technological advantage of foreign enterprises in the high-end medical device field; on the other hand, it also provides a new benchmark for China-produced innovations to catch up.

Conclusion

Currently, the cumulative number of innovative medical devices listed in China has reached 354. Medtronic's Aurora EV-ICD Extravascular Implantable Cardioverter Defibrillator has opened a new frontier in ICD treatment methods and will also bring more advanced treatments to patients in China.

References:
1. Medtronic Official Website

Editor: Mu Mian

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