Johnson & Johnson Unveils Javelin: World’s First Balloon-Free Peripheral IVL Catheter for Chronic Total Occlusions

Recently, ShockWave Medical, a subsidiary of Johnson & Johnson, officially unveiled its latest generation of balloon-free peripheral IVL catheters at TCT (the most important educational forum for researching interventional cardiology worldwide) 2024. This product is designed to "clear" completely occluded blood vessels and address the challenges of treating vascular calcification.

Vascular calcification can easily cause vascular blockage and thrombosis. If the calcified plaque ruptures, it may also lead to cardiovascular events. Moreover, in coronary interventional treatments, such as when there is coronary artery calcification, it may hinder stent placement and expansion, making it difficult for the coronary stent to be properly positioned and adhere to the vessel wall, increasing the risk of coronary rupture, thereby resulting in a lower success rate of PCI procedures and poorer prognosis.

At the same time, the incidence of diseases is also gradually increasing. For example, in the case of coronary artery calcification, according to the "Chinese Expert Consensus on Diagnosis and Treatment of Coronary Artery Calcification (2021 Edition)," the incidence of coronary artery calcification in the 40-49 age group is about 50%, while in the 60-69 age group, it has "soared" to 80%.

Whether it is coronary artery calcification or peripheral artery calcification, both are very challenging in interventional treatment, especially deep calcified lesions, which have earned the title of "the hardest bone" or "the toughest fortress." This has also attracted many enterprises at home and abroad to tackle the problem. They are trying to solve this cardiovascular treatment challenge from different technical perspectives.

At present, there are four main interventional therapies for vascular calcification in clinical practice: Cutting Balloon Angioplasty (CBA), Coronary Rotational Atherectomy (RA), Excimer Laser Coronary Atherectomy (ELCA), and Intravascular Lithotripsy (IVL).

Among them, cutting balloon angioplasty is the most common interventional treatment for vascular calcification in clinical practice. As of October this year, a total of 7 products have been approved in China, including 3 products from Boston Scientific, 2 products from Lepu Medical, 1 product from Baiyi Hui, and 1 product from Shenqi Medical.

However, cutting balloon angioplasty can only be used to address mild to moderate calcified lesions and cannot treat severe calcified vascular conditions. Therefore, some companies have begun to focus on plaque旋磨术. For example, Boston Scientific's Rotational Atherectomy System.

However, due to complications associated with plaque atherectomy and the high level of technical skill required from physicians, the market scale for plaque atherectomy has not been able to expand significantly. According to a previous report by VCBeat, although Boston Scientific’s coronary atherectomy product has been in the Chinese market for a relatively long time, it only surpassed 10,000 cases in 2021. Moreover, even in developed regions like Europe and the United States, the application rate of atherectomy products in PCI remains at only 5%.

Perhaps it is precisely because of this reason that Boston Scientific joined the list of Shockwave's acquirers. Apart from Boston Scientific, the names of Johnson & Johnson and Medtronic also appeared on the list at that time. To date, the acquisition outcome has been made public—Johnson & Johnson acquired Shockwave for a staggering $13.1 billion.

The reason why Shockwave has gained favor with giants is straightforward: its star product, "Shockwave IVL," is the only technology that offers treatment for deep calcified lesions. Its unique mechanism of action enhances surgical safety by restoring vascular elasticity and reshaping blood flow in diseased vessels while avoiding damage to the vascular intima.

Not only that, but "Shockwave IVL" has also shown outstanding performance in commercialization. It is reported that the product quickly completed its rollout in major cardiovascular disease markets, including the United States, Europe, China, and Japan. Compared to other products that require up to a decade to achieve global commercialization, the speed of IVL system’s commercialization demonstrates clinical recognition of this technology.

Shockwave's excellent commercial performance has allowed it to build strong brand influence in the IVL field, creating a tight association with IVL and establishing itself as the leading company in this area at present. This IVL leader continues to make significant progress.

Compared with the previous "Shockwave IVL," the new generation of peripheral IVL balloon-free catheter Javelin launched by Shockwave Medical has two differences.

First, as the name suggests, the Javelin catheter does not have a balloon design. It mainly consists of a flushing catheter lumen, a guidewire lumen, a pressurizing lumen, and a shockwave generator. Among these, the pressurizing lumen can be filled with saline solution to achieve the predetermined treatment pressure. The flushing catheter allows the treatment area to be flushed with saline, while the guidewire lumen is used for the passage of a 0.36mm guidewire. The shockwave generator of this catheter is designed at the farthest end of the catheter, enabling the transmission of shockwaves directly forward. These shockwaves deliver 12 rounds of shockwaves (10 times per round, totaling 120 times) to "impact" the occluded blood vessels.

Secondly, the Javelin catheter is currently used to "recanalize" completely occluded vessels and is only applicable for delivering shockwaves and crossing calcified lesions in peripheral arteries, including the iliac artery, femoral artery, iliofemoral artery, popliteal artery, and infrapopliteal artery. It has not been used for calcified coronary artery lesions. It is expected that Shockwave will further expand its indications for coronary arteries in the future, potentially addressing one of the two most challenging "fortresses" in cardiology: the CTO problem.

At TCT2024, J.D. Corl from Christ Hospital also shared a case. In this case, after treatment with the Javelin catheter, an 85-year-old woman with a 92mm severe calcified lesion in her left anterior tibial artery not only achieved patency of the left anterior tibial artery, but her minimum lumen diameter on angiography also reached 1.9mm.

As Shockwave Medical intensifies its efforts in the treatment of completely occluded vessels, domestic companies in China have also made breakthroughs in the IVL field.

In October 2023, Saihe Medical's self-developed coronary intravascular shockwave treatment system received NMPA approval, becoming the first approved domestically produced coronary shockwave treatment system in China. The system consists of the LiqMagic® C14 single-use coronary intravascular shockwave catheter and the ISL100 Pro intravascular shockwave treatment device. By providing pulsed driving electrical energy to its shockwave catheter, it can output divergent, low-intensity shockwave energy outward in a 360° full circumferential and intermittent manner, thereby exerting a fracturing effect on calcified plaques, improving vascular compliance, and preparing for subsequent treatments.

In addition, to fully meet the diverse clinical treatment needs, LiqMagic® C14 disposable intracoronary lithotripsy catheter also features more pulses (100 times), higher pressure resistance (RBP reaching 14atm), and a more comprehensive range of specifications (2.5-4.0mm, with a total of 7 specifications).

In March this year, the coronary intravascular lithotripsy system independently developed by Pulson Medical also received NMPA approval. The system consists of the SONICO-CX® single-use coronary intravascular lithotripsy catheter and the intravascular lithotripsy device. By providing pulsed driving electrical energy to the lithotripsy catheter, it releases shockwaves circumferentially at 360° and intermittently. The acoustic energy directly targets and fractures calcified plaques within the intima and media, thereby restoring vascular compliance.

In addition, C-Wave® Intravascular Lithotripsy Catheter and Generator System of Zhong Hui Medical, a wholly-owned subsidiary of Huihe Medical, has also received NMPA approval. It can be used in conjunction with its manufactured intravascular lithotripsy treatment device to perform balloon dilation and pre-treatment on adult patients with calcified lesions in the iliac artery, femoral artery, iliofemoral artery, popliteal artery, renal artery, and infrapopliteal artery.

Blue Sail Medical's subsidiary, Blue Sail Boyuan, has also developed a high-performance coronary calcium shock wave system. This system innovatively designs high-efficiency electrodes, ensuring sufficiently high acoustic pressure energy distribution between the two electrodes, making it suitable for long lesion treatment. Additionally, Blue Sail Medical's dual-layer balloon material provides higher post-dilation capability after acoustic pressure treatment, allowing for more thorough vascular pre-treatment. For IVL catheters, Blue Sail Boyuan offers a wide range of IVL catheter models and specifications to more precisely meet the needs of complex lesion pre-treatment, assisting clinicians in managing longer calcified lesions.

Blue Sail Medical, Pu Chuang Medical, Sai He Medical, Pei Jia Medical... Domestic companies frequently appear in the IVL track. However, facing international leaders with more mature commercialization and beginning to focus on more细分 treatment scenarios, what surprises can domestic companies bring in the future?