Johnson & Johnson Unveils Next-Gen IVL Technology with FDA-Approved Shockwave E8, Disrupting the $200B Vascular Intervention Market

Recently, Johnson & Johnson announced that its subsidiaryLatest Shockwave Balloon Shockwave E8 Approved by FDA for Market Launch, and began full-scale promotion in the United States.

It is reported that the Shockwave E8 approved this time is currently the longest shock wave balloon, and alsoThe World's FirstBased on the Shockwave balloonIterative UpgradeThe product, by emitting sound pressure waves to act on the calcified area, effectively loosens or fractures the calcified lesion, providing patients with arterial vascular disease a better stent treatment option.

In fact, Shockwave E8 is Johnson & JohnsonAcquired for $13.1 billion (approximately RMB 94.8 billion)And come.

Such a large-scale acquisition is precisely because the first-generation Shockwave intravascular lithotripsy balloon catheter pioneered a completely new treatment method for peripheral arterial vascular calcification—IVL (Intravascular Lithotripsy), which is also the most promising emerging interventional technology in the field of vascular intervention.

Currently, Peripheral Artery Disease (PAD) has become a significant global public health issue. As an atherosclerotic occlusive disease of the lower limb arteries, it affects millions worldwide.289 million patientsThe quality of life, with its most severe manifestation being chronic limb-threatening ischemia (CLTI), which has a high mortality rate and is clinically more challenging to treat than most cancers.

Traditional treatment methods areThrough intraluminal balloon dilation and stent implantation to restore the arterial lumen, achieving the reconstruction of the blood flow transport channel. However, these methods can only address the superficial calcification of the vascular intima.Unable to handle calcified nodules or severe calcification; At the same time, calcified plaques are usually difficult to be expanded by ordinary balloons, which also affects the subsequent use of drug-coated balloons and stents.

AndIVL TreatmentBy releasing pulsed acoustic pressure waves to the affected area,High Efficiency and SafetySuperficial and Deep Calcification Disruption。This technique is also referred to in the "Chinese Expert Consensus on Diagnosis and Treatment of Coronary Artery Calcification (2021 Edition)" as"The Terminator" of Arterial Calcification.

Johnson & Johnson's acquisition of Shockwave technology has established its leading position in the IVL field and provided it with a unique technical understanding of IVL.

Currently, the Shockwave intravascular lithotripsy balloon has been used globally for nearly400,000 patientsProviding treatment, its clinical performance has always been extremely outstanding.

As early as 2021, Shockwave intravascular lithotripsy balloon technology was introduced into clinical use in the United States and was approved for marketing in China in 2022. In China, medical institutions such as Guangdong Cliff Hospital and Xiangtan Central Hospital were among the first to carry out related clinical trials, andHas achieved remarkable results.

And with the advent of the latest generation Shockwave E8, its groundbreaking shock wave length,Will help more doctors refine their treatment algorithms, better supporting patients with severeChallenging patients with calcified diseases.

According toPresident and Chief Commercial Officer of Johnson & Johnson's Shockwave Medical stated"Shockwave E8 represents a commitment to physician-guided innovation while maintaining the simplicity and effectiveness of IVL technology."

"We have received very positive feedback from doctors on the Shockwave E8 and look forward to establishing it as our new main peripheral IVL catheter, providing doctors with solutions for both above-the-knee and below-the-knee calcium challenges."

As an innovative treatment for arterial vascular diseases, since the invention of Intravascular Lithotripsy (IVL) technology by Shockwave in 2018, its products have been successively approved in the United States for peripheral artery and coronary artery calcium indications. With its safe and effective clinical outcomes, as well as easy-to-use intraoperative procedures, it is considered by the industry to be...A Great Leap Forward in the Treatment of Calcified Lesions.

Behind Johnson & Johnson's entry into the Shockwave balloon market lies a significant driving force in the rapid development of the IVL market. According to iData Research, the global IVL market was valued at$25.87 billion (RMB 182.29 billion), with a compound annual growth rate of 9.3%, indicating significant market potential.

After divesting its consumer health business, Johnson & Johnson has been focusing on the medical device field. Johnson & Johnson, which is in a period of transition, continues toSeeking Growth Opportunities with Stronger Momentum。

Among them, Johnson & Johnson's large-scale acquisition this year to boost its stake in Shockwave Medical, a vascular calcification technology company, demonstrates its confidence and ambition in the IVL device market.

According to Johnson & Johnson's latest financial data, the revenue of Johnson & Johnson's cardiovascular business in the first half of 2024 was $3.679 billion, a year-on-year increase of 17.8%. This growth was mainly driven byIntegration and Expansion of Vascular Intervention Business After the Acquisition of Shockwave.

And Shockwave, one month after being acquired by Johnson & Johnson,Sales also reached 77 million US dollars., a substantial increase in performance, demonstrating the competitiveness and clinical acceptance of its products in the market.

Compared to other products that require up to a decade to achieve global commercialization, the rapid commercialization of the IVL system demonstrates clinical recognition of this technology. With its high growth momentum, it is expected to become a major hit in the vascular intervention field.

Currently, Shockwave Medical has established direct sales points in the United States, Germany, Austria, and Switzerland. And in North America and South America, Europe, the Middle East, Asia, Africa, and Australia.A distributor network has been established in more than 50 countries.。

In the U.S., the main battlefield, there are approximately 8 million PAD (peripheral artery disease) patients, of which 20% are troubled by CLTI (chronic limb-threatening ischemia). The recently approved Shockwave E8 from Johnson & Johnson,The commercial prospects are also bound to be very strong.

The huge commercial prospects will inevitably not be dominated by Johnson & Johnson alone. In the IVL track,Abbott, Medtronic, Boston ScientificGiants like Johnson & Johnson are also eyeing the market, actively making strategic moves.

Last year,AbbottAnnounced on the official websiteInvested 6.1 billion yuanCompletion of the acquisition of Cardiovascular Systems (hereinafter referred to as CSI)Acquisition. And the acquired party, CSI, is precisely ShockWave's direct competitor.

As an innovative company, CSI also holds a significant position in the field of treating vascular and coronary artery diseases, and its innovative technology for treating complex arterial diseases was a key factor in Abbott's acquisition.

It is reported that the Diamondback 360 series products under CSI are the two most popular vascular calcification cutting systems, and in 2007First approved by the FDA for the treatment of peripheral calcification."The acquisition of CSI is an important part of our overall investment in the vascular product portfolio," said the Executive Vice President of Abbott Medical Devices.

AndMedtronicAndBoston ScientificAlthough it failed in the bidding war against Johnson & Johnson for Shockwave Medical in April this year, it has also been actively developing products in the vascular calcification field to capture the market:

These products are devices used to treat vascular stenosis and calcification, helping to restore the natural patency of blood vessels. From Johnson & Johnson to Abbott, Medtronic, and Boston Scientific, it is clear that,IVL has become a battleground for leading cardiovascular companies.

So, what is the situation like in the Chinese market for the golden track that the giants in the international market are investing heavily in?

According to statistics, the number of patients with peripheral arterial disease in China increased from 47.113 million in 2017 to 51.872 million in 2021, with a compound annual growth rate of 2.43%. It is estimated that by 2030,The number of patients will increase to 62.3044 million., with a compound annual growth rate (CAGR) of 2.06% from 2021 to 2030.

Under the huge market scale, China's broader peripheral intervention market space has also been spurred. According to a forecast by Frost & Sullivan,It is estimated that by 2030, the peripheral intervention market will grow to 30 billion yuan.

But in reality, this forecasted outcome might arrive earlier. As early as 2022, numerous enterprises in China witnessed substantial revenue growth in the peripheral intervention sector.The average increase reached over 200%:

And with the aging population in China, the increasing incidence of chronic diseases such as diabetes, the prevalence of peripheral arterial disease is also on the rise, and the peripheral interventional IVL market will also see growth.Product and Commercialization New Growth。

In fact, since Jianshi Medical introduced the Shockwave product to China for the first time in 2021, the competitive landscape of the domestically produced IVL sector has been opened up.

May 2022,Gian HealthcareThe IVL product from the U.S.-based ShockWave company has been successfully approved for marketing in China. Subsequently, the product has rapidly expanded across the country and has already reached grassroots county-level hospitals, with plans to achieve further milestones in China.Full Commercialization。

Subsequently,Lepu MedicalThe first case of severe calcified popliteal artery lesion opening surgery using the Angiocrack™ pulsed acoustic wave balloon system for peripheral arteries has been successfully completed. Clinical enrollment has been finished, and efforts to advance product registration are currently underway.

In June this year,Saihe MedicalThe LiqMagic® Peripheral Shockwave Catheter released clinical research for peripheral arterial vascular calcified lesions, confirming the effectiveness of intravascular shockwave treatment for calcified lesions and the significant immediate lumen gain after shockwave application.

In addition, there are nearly 10 medical device companies in China currently conducting research, clinical trials, or registration, with R&D enthusiasm continuing to rise. Chinese-produced peripheral interventional IVL products are about to experience a major boom.

In fact, the accelerated layout of IVL products made in China is also due to encountering"Normalization of Volume-based Procurement"Accelerate the trend of domestic substitution.

Since 2020, important products for interventional surgeries such as stents, balloons, catheters, and guidewires have been included in multiple rounds of centralized procurement price cuts, marking the beginning.High-Value Non-Powered Consumables Procurement in ChinaThe bugle call.

And amid the storm of centralized procurement,Active interventional devices represented by IVL products, as a cutting-edge innovative technology at present, can effectively avoid the risks associated with centralized procurement and ensure profitability in the short term. Such products have promising development prospects in China and also mark a significant opportunity for domestically produced products.Market Expansion and Volume IncreaseA perfect opportunity.

On the global IVL track, cardiovascular giants such as Johnson & Johnson, Medtronic, and Abbott have embarked on a comprehensive competitive journey. In China’s emerging IVL peripheral intervention market, imported and domestically produced products are almost on the same starting line. Apart from leveraging favorable policy support, enhancing product innovation capabilities and strengthening commercialization strategies will be key to the rise of China-produced IVL enterprises.