Medtronic's Next-Generation Micra AV2 and VR2 Wireless Pacemakers Receive CE Mark

Jan 08, 2024 18:05 CST Updated 18:05

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Source: Medical Device Innovation Network

On January 5, 2024, Medtronic announced that its two miniature leadless pacemakers, Micra AV2 and Micra VR2, had successfully obtained the European CE Mark certification. This breakthrough achievement not only highlights Medtronic's continued leadership in cardiac pacing technology but also adds another significant milestone to its innovative journey in patient care for heart disease. Since inventing the first wearable pacemaker in 1957, Medtronic has been committed to the exploration and innovation of cardiac pacing technology.

Micra AV2 and Micra VR2 Leadless Cardiac Pacemakers

1.75g Pacemaker

Micra AV2 & Micra VR2 are upgrades to Medtronic's first-generation leadless pacemakers, retaining the same appearance and most of the design features. Therefore, their surgical procedure is identical to that of the first-generation leadless pacemaker, and they also possess all the advantages of the first-generation device.

Medtronic hails it as the world’s smallest pacemaker. Compared to earlier versions, Micra AV2 and Micra VR2 offer longer battery life and more convenient programming. The battery life of these two products has increased by approximately 40% compared to the previous generation, with Medtronic estimating their battery life to reach nearly 16 and 17 years, respectively. However, Medtronic emphasizes that these devices still retain the advantage of leadless pacing, which can reduce the risk of complications compared to traditional pacemakers. According to a press release, over 80% of patients receiving Micra pacemakers may only need to use one device for their entire lifetime.

The Micra device also has remote monitoring capabilities, which are expected to reduce hospitalizations and enhance patients' sense of security. Its size is only about one-tenth that of a traditional pacemaker. Unlike conventional devices, the Micra device does not require leads or a subcutaneous surgical "pocket," thereby reducing complications associated with leads and pockets and eliminating visible device markings.

Medtronic's Vice President and General Manager of the Cardiac Rhythm Management Business, Robert C. Kowal, M.D., Ph.D., said, "For more than eight years, our Micra leadless pacemaker has provided meaningful benefits to patients who need a pacemaker. Now these patients have access to the latest in leadless pacing technology, which for most of them may be the only device they will ever need."

Global Pacemaker Market Analysis

The global market for cardiac pacemakers is rapidly expanding, particularly in China’s vast market. According to Huamei statistics, the global cardiac pacemaker market size reached $4.51 billion in 2022 and is projected to have a compound annual growth rate (CAGR) of 3.6% from 2023 to 2030. The increasing burden of cardiovascular diseases has become one of the key factors driving market growth. Forecasts indicate that by 2028, the global cardiac pacemaker market size will climb to $6.14 billion.

Data Arrangement: Huamei

Another study from WeiDu Consulting shows that in 2021, the U.S. pacemaker market size reached USD 16.179 billion, accounting for the largest global market share (45.0%). It is projected that China will become the fastest-growing pacemaker market, with a forecasted compound annual growth rate (CAGR) of 5.7% from 2021 to 2030.

Data Source: WeiDu纵横

In China's market, the penetration rate of pacemakers is relatively low. Due to factors such as technical barriers, foreign brands dominate the market. Boston Scientific, Medtronic, and Abbott are global leaders in the pacemaker industry, collectively accounting for nearly 85.0% of China’s market. By the end of 2023, only three domestically produced brands—Lepu Medical, LifeTech Scientific, and MicroPort (LeaderMed)—had received product approval. Currently, dual-chamber pacemakers have become the core product in China's pacemaker market. Statistics show that in 2021, the number of clinical implants of dual-chamber pacemakers in China reached 85,420 units, accounting for 76% of the total market.

Data Compilation: Huamei

From a product perspective, the development of commercial pacemakers is primarily dominated by five multinational companies: Medtronic, Abbott, Boston Scientific, Biotronik, and MicroPort. The table below provides a detailed comparison of these companies' main pacemaker products approved in the United States, the European Union, and China.

Policy-Driven Development

The rising incidence of cardiovascular diseases globally, coupled with the intensifying trend of aging, has led to a continuous growth trend in the pacemaker market. Each year, the World Health Organization reports approximately 41 million deaths from cardiovascular diseases worldwide, accounting for 74% of total non-communicable disease deaths, underscoring the importance and urgency of optimizing care for heart disease patients.

Therefore, in recent years, China has issued relevant policies and regulations many times, listing implantable medical devices as a key development area, strongly promoting the development of cardiovascular interventional devices, encouraging domestic innovation, and striving to break the import monopoly. At the same time, China has successively carried out centralized procurement of high-value medical consumables, with Jiangsu Province being the first to initiate the procurement of dual-chamber pacemakers, followed by Yunnan, Qinghai, Anhui, Shandong, Fujian, and other provinces gradually starting the procurement of cardiac pacemakers.

As the scale of production in China and centralized procurement expands, the price of implantable cardiac pacemakers will no longer remain excessively high. In the 2022 centralized procurement in Shaanxi Province, the average price of non-MRI-compatible cardiac pacemakers from selected manufacturers, such as Lepu Medical and CHL Medical, has dropped to around 16,000 yuan. With the improvement in patients' medical awareness, the increase in pacemaker penetration rates, and the rise in medical insurance reimbursement ratios, user acceptance of cardiac pacemakers will also continue to grow.

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