Johnson & Johnson Announces Launch of its Shockwave Javelin Peripheral Intravascular Lithotripsy Catheter in Europe to Transform Treatment of Difficult-to-Cross Calcified Lesions

SANTA CLARA, Calif. - September 15, 2025 - Today, Johnson & Johnson announced the European launch of its Shockwave Javelin Peripheral IVL Catheter, a novel intravascular lithotripsy (IVL) platform designed to modify calcium in extremely narrowed vessels to expand treatments in patients suffering from peripheral artery disease (PAD). The first-of-its-kind Forward IVL platform includes a catheter with a single lithotripsy emitter placed directly behind the tip of the device and has a similar safety and effectiveness profile to legacy Shockwave IVL catheters, bolstering the company's market-leading IVL portfolio.

PAD is the narrowing or blockage of the vessels that carry blood to the legs that reduce blood flow, resulting in debilitating symptoms, ulceration and an increased risk of amputation. People suffering from PAD have an impaired quality of life and increased risk of heart attack or stroke.1 More than 230 million people worldwide and around 15 million people aged 45 and older in Europe suffer from PAD.^1,2,3 Chronic limb-threatening ischemia (CLTI), the most advanced and serious form of PAD impacting nearly 25 million patients worldwide,1 has a 40% major amputation rate at one year from initial diagnosis and a 50% mortality rate at five years, worse than most forms of cancer.1

"The Shockwave Javelin Peripheral IVL catheter helps address one of the most persistent technical barriers in complex below the knee (BTK) revascularization - the 'device-uncrossable' calcified lesion," said Dr. Narayanan Thulasidasan, Consultant Interventional Radiologist at Guy's and St Thomas' NHS Foundation Trust, London, UK.^†

"Previously, there were few reliable options for effective treatment of these uncrossable BTK vessels. The Javelin IVL catheter helps bridge a critical gap in the management of CLTI in patients with complex multi-level disease," said Dr. Ashish Patel, Consultant Vascular and Endovascular Surgeon at Guy's and St Thomas' NHS Foundation Trust and Reader in Vascular Surgery and Sciences at King's College London in London, UK.^†

The novel Javelin Forward IVL platform is designed to modify calcified occlusive disease or extremely narrowed lesions where a wire will cross but devices might not. Shockwave Javelin has a working length of 150 centimeters and features a single distal emitter that can provide120 shock waves, spherical ultrasonic acoustic pressure waves, that extend beyond the tip of the catheter. This novel design allows delivery of lithotripsy closer to occlusive calcific lesions than the balloon-based platform could enable. Despite the challenging nature of the complex patients and calcified lesions studied, the clinical outcomes from the FORWARD PAD IDE trial demonstrated that Shockwave Javelin has a similar safety and effectiveness profile to balloon-based Shockwave IVL catheters.

"Shockwave is at the forefront of IVL technology, and we continue to address unmet physician needs," said Nick West, M.D., Chief Medical Officer, Shockwave Medical. "We developed our first-of-its-kind forward IVL platform through conversations with physicians, leveraging their valuable insights to develop a platform with the capability to modify calcium and cross extremely narrowed vessels. We are proud to set the standard in generating an expansive portfolio for endovascular interventionalists to address their unmet needs and move the goalposts of what's expected from IVL technology in the reduction of risks associated with CLTI."

Intravascular Lithotripsy (IVL) is the energy-based generation of ultrasonic acoustic pressure waves for modification, fracture and fragmentation of vascular calcification. Combined with Shockwave E8, Shockwave L6 & Shockwave M5+ IVL catheters, the addition of the Shockwave Javelin Peripheral IVL catheter offers physicians a comprehensive IVL portfolio to treat challenging calcified lesions both above and below the knee, spanning the entire peripheral anatomy.

About Shockwave Medical
Shockwave Medical Inc., part of Johnson & Johnson MedTech, is a leader in the development and commercialization of innovative products that are transforming the treatment of cardiovascular disease. Its first-of-its-kind Intravascular Lithotripsy (IVL) technology has transformed the treatment of atherosclerotic cardiovascular disease by safely using sonic pressure waves to disrupt challenging calcified plaque, resulting in significantly improved patient outcomes. Its Reducer technology, which is under clinical investigation in the United States and is CE Marked in the European Union and the United Kingdom, is designed to provide relief to the millions of patients worldwide suffering from refractory angina by redistributing blood flow within the heart. Learn more at https://www.shockwavemedical.com.

Cardiovascular Solutions from Johnson & Johnson MedTech
Across Johnson & Johnson, we are tackling the world's most complex and pervasive health challenges. Through a cardiovascular portfolio that provides healthcare professionals with advanced mapping and navigation, miniaturized tech, and precise ablation, we are addressing conditions with significant unmet needs such as heart failure, coronary artery disease, stroke, and atrial fibrillation. We are the global leaders in heart recovery, circulatory restoration and the treatment of heart rhythm disorders, as well as an emerging leader in neurovascular care, committed to taking on two of the leading causes of death worldwide in heart failure and stroke.

About Johnson & Johnson
At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow and profoundly impact health for humanity. Learn more about our MedTech sector's global scale and deep expertise in cardiovascular, orthopaedics, surgery and vision solutions at https://thenext.jnjmedtech.com. Follow us at @JNJMedTechand on LinkedIn. Shockwave Medical, Inc. is a Johnson & Johnson company.

Cautions Concerning Forward-Looking Statements
This press release contains "forward-looking statements" as defined in the Private Securities Litigation Reform Act of 1995 related to Shockwave Javelin Peripheral IVL Catheter. The reader is cautioned not to rely on these forward-looking statements. These statements are based on current expectations of future events. If underlying assumptions prove inaccurate or known or unknown risks or uncertainties materialize, actual results could vary materially from the expectations and projections of Johnson & Johnson. Risks and uncertainties include, but are not limited to: competition, including technological advances, new products and patents obtained by competitors; uncertainty of commercial success for new products; the ability of the company to successfully execute strategic plans; impact of business combinations and divestitures; challenges to patents; changes in behavior and spending patterns or financial distress of purchasers of health care products and services; and global health care reforms and trends toward health care cost containment. A further list and descriptions of these risks, uncertainties and other factors can be found in Johnson & Johnson's most recent Annual Report on Form 10-K, including in the sections captioned "Cautionary Note Regarding Forward-Looking Statements" and "Item 1A. Risk Factors," and in Johnson & Johnson's subsequent Quarterly Reports on Form 10-Q and other filings with the Securities and Exchange Commission. Copies of these filings are available online at www.sec.gov, www.jnj.com, www.investor.jnj.com or on request from Johnson & Johnson. Johnson & Johnson does not undertake to update any forward-looking statement as a result of new information or future events or developments.

Footnotes
^† Dr. Patel & Dr. Thulasidasan are paid consultants for Shockwave Medical. They have not been compensated in connection with this press release.

¹ https://www.ahajournals.org/doi/full/10.1161/CIRCOUTCOMES.120.007539#core-R1-1

² PVD European data from: https://ehnheart.org/about-cvd/the-burden-of-cvd/ with applied % to get PAD segment found in https://pubmed.ncbi.nlm.nih.gov/23642926/

³ https://www.cdc.gov/heart-disease/about/peripheral-arterial-disease.html

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