Johnson & Johnson Launches Fifth-Generation Shockwave C2 Aero Intravascular Lithotripsy Catheter Globally

# What clinical pain points does C2 Aero address compared to its predecessor?

Intravascular Lithotripsy（Intravascular Lithotripsy, IVL）The mechanism of action isUltrasonic pulse sound pressure waves generated by a lithotripter built into the catheter penetrate soft tissues and fragment calcified plaques within the vascular wall, preparing for subsequent balloon dilation and stent implantation.This mechanism has been fully validated in the DISRUPT CAD series of clinical studies.

But the previous generations of products have several high-frequency pain points in clinical use.First, insufficient deliverability: In the face of severely tortuous coronary anatomy or dense calcification-induced stenosis, it is difficult for the catheter to reach and cross the target lesion. Second, repositioning difficulties: After balloon dilation, it is hard to retract tightly, limiting the catheter’s repositioning within the vessel, often leaving operators with only a unidirectional treatment strategy from distal to proximal. Third, reliance on auxiliary devices: Clinically, additional auxiliary devices (such as microcatheters, extension catheters, etc.) are often required to assist in positioning and crossing, increasing procedural complexity and duration.

C2 Aero has made corresponding upgrades for these three pain points.The catheter shaft, balloon, and marker band all adopt a more compliant design to enhance deliverability in tortuous vessels; the distal end of the catheter is equipped with a tapered tip and hydrophilic coating to improve passage through densely calcified lesions; the balloon uses new materials, allowing for a tighter profile after deflation, enabling the catheter to be repositioned bidirectionally within the vessel (movable both proximally and distally) to treat multiple lesions or recross lesions. Working length: 138cm, with two built-in lithotripsy emitters capable of delivering up to 120 pulses simultaneously (generating 240 shockwaves).

# All Four Giants Enter the Market Within Two Years: IVL Competition Landscape Officially Enters the Multi-Player Era

The timing of the C2 Aero's launch coincides with an unprecedented period of intense competition in the global IVL market.

During the two-year period from 2024 to 2026, the four major device giants successively completed their IVL layout through mergers and acquisitions—a rare occurrence on a single technology platform in the field of cardiovascular intervention.

• Johnson & JohnsonJ&JInCompleted the Acquisition of Shockwave Medical for $13.1 Billion in 2024, which was the largest M&A deal in the medical device industry that year. This transaction not only allowed Johnson & Johnson to acquire the entire product line of IVL, a high-growth category (coronary, peripheral, structural heart disease), but also included the evidence-based medical data barrier accumulated from the DISRUPT series of clinical studies. Shockwave Medical remains independently operated as a standalone brand within the Johnson & Johnson system.

• Boston ScientificInCompleted the acquisition of Bolt Medical in January 2025, with a maximum transaction value of $6.64 billion. Bolt's IVL platform is based on the mechanism of laser-induced pressure waves, differing from Shockwave's electrohydraulic lithotripsy approach. According to public reports, Bolt’s coronary IVL system received FDA approval in April 2025.

• AbbottThe IVL layout was even earlier ——Acquired Cardiovascular Systems (CSI) for $890 million in 2023After acquiring rotational atherectomy and orbital atherectomy technologies, further independent research and development of the IVL system was conducted. In March 2025, Abbott received FDA IDE approval to initiate clinical trials of its coronary IVL system in the United States.

• StrykerIs the latest entrant.Announced the acquisition of Amplitude Vascular Systems (AVS) in April 2026The transaction was completed in early May. AVS's Pulse IVL System, which utilizes pressure waves generated by pulsed CO₂, is targeted at peripheral artery disease (PAD) and is currently still in the IDE stage. Following Stryker's acquisition of Inari Medical for approximately $4.9 billion in 2025, peripheral vasculature has become a strategic growth area, with AVS representing a continuation of this strategy. Leerink Partners analyst Mike Kratky described the Pulse system as "one of the most credible next-generation challengers to Shockwave IVL."

In addition, several small and medium-sized companies are advancing IVL platforms: FastWave Medical, Elixir Medical, Vantis Vascular, etc. According to GlobalData analysis, the competing products from Abbott and Boston Scientific may not achieve commercialization until at least 2028 — meaning Johnson & Johnson still enjoys an exclusive window of at least two years in the coronary IVL field. Johnson & Johnson’s decision to launch its fifth-generation product within this timeframe, rather than waiting for competitors' products to hit the market before making passive upgrades, demonstrates a very clear strategic intent.

# China Market: Multiple IVL Certificates for Chinese-Made Products Have Been Approved; Price War Precedes Technology War

The competitive landscape of China's IVL market is completely different from overseas, characterized by "import-led cultivation, rapid domestic follow-up, and price-first exploration."

Shockwave's coronary IVL catheter received NMPA approval in 2022 and is exclusively represented by Jian Shi Medical.Subsequently, Jianwei Medical (Wuxi), a subsidiary of Jianshi Medical, completed the localization of Shockwave's coronary IVL products in China, enabling Shockwave to possess both import and locally produced registration certificates in China. According to public reports, the online listing price of Shockwave products in China is approximately 29,800 RMB per unit.

On the side of Chinese enterprises, Shenzhen Saihe Medical's coronary shockwave lithotripsy system was approved by NMPA in October 2023, becoming the first domestically produced coronary IVL product to be approved, with a listed price of approximately 19,800 yuan. Beijing Lepu Medical's coronary shockwave catheter system was approved by NMPA in January 2024, with a listed price of approximately 17,800 yuan. Lanfan Boyuan (a subsidiary of Shanghai Lanfan Medical) independently developed the Soni Cracker™-CL Coronary Intravascular Shockwave Catheter, which received NMPA approval in August 2024, offering balloon diameters starting from 2.0mm and lesion treatment specifications of 15mm in length. Other companies in the research and development phase include Puchuang Medical (Sonico system, in clinical collaboration with Fudan Zhongshan Hospital), MicroPort Medical (Melody™ Coronary Shockwave System), Zhonghui Medical (C-Wave Peripheral System), Xinkang Medical, and others. Industry insiders estimate that dozens of companies are in line to obtain certification.

Following the launch of C2 Aero by J&J, it remains to be seen whether Shockwave Medical’s product strategy in China will be updated accordingly and whether the deliverability and repositioning capabilities at the level of C2 Aero will become the benchmark for the next round of product upgrades by domestically produced enterprises.

# Heart Future·Observation

The current competitive landscape of the IVL track can be summarized in one sentence: Johnson & Johnson is leveraging product generational leadership to offset the influx of upcoming competitors.

The upgrade directions for C2 Aero—deliverability, trackability, and balloon retraction—are not "from 0 to 1" breakthroughs, but rather refined iterations "from functional to user-friendly."This is precisely the product capability that IVL needs to expand from early adopters to a broader group of operators: lowering the operational threshold, reducing reliance on auxiliary devices, and enabling more operators of moderate-complexity PCI to dare to use IVL.

For the Chinese market, the refined iteration of products like C2 Aero raises another layer of issues: domestic IVL companies currently establish differentiation mainly on price. However, when imported products continuously widen the gap in operational experience, whether the sole advantage of price can be sustained depends on whether domestic companies can catch up in the "soft power" of catheter delivery performance. The penetration rate of IVL in China’s PCI is still in its early stages, and operators' sensitivity to operational experience will rapidly increase as usage volume grows.