Johnson & Johnson has announced the European launch of its Shockwave Javelin Peripheral Intravascular Lithotripsy (IVL) Catheter, a new device designed to help treat patients with peripheral artery disease (PAD). The catheter is intended to address severely narrowed blood vessels by using lithotripsy technology to modify calcified lesions that are difficult for other devices to cross.
Peripheral artery disease affects more than 230 million people globally and about 15 million people aged 45 and older in Europe. The most advanced form of PAD, chronic limb-threatening ischemia (CLTI), impacts nearly 25 million patients worldwide and is associated with high rates of amputation and mortality. According to recent data, CLTI carries a major amputation rate of 40% within one year of diagnosis and a five-year mortality rate of 50%, which exceeds that of most cancers.
Dr. Narayanan Thulasidasan, Consultant Interventional Radiologist at Guy’s and St Thomas’ NHS Foundation Trust in London, said: “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.”
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, added: “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.”
The new platform features a single lithotripsy emitter positioned directly behind the tip, enabling delivery of up to 120 shock waves beyond the end of the catheter. This design allows physicians to target hard-to-reach occlusive calcific lesions more closely than previous balloon-based platforms. Results from the FORWARD PAD IDE trial indicate that Shockwave Javelin offers safety and effectiveness similar to existing balloon-based Shockwave IVL catheters.
Nick West, M.D., Chief Medical Officer at Shockwave Medical, stated: “Shockwave is at the forefront of IVL technology, and we continue to address unmet physician needs. 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.”
Shockwave Medical Inc., part of Johnson & Johnson MedTech, develops products aimed at improving cardiovascular treatments through technologies like intravascular lithotripsy—using sonic pressure waves for plaque disruption—and is also investigating Reducer technology for refractory angina relief.
Johnson & Johnson MedTech provides healthcare professionals with cardiovascular solutions such as mapping systems, miniaturized devices, ablation tools, as well as being active in heart recovery and neurovascular care.
Cautionary statements note that forward-looking statements about product performance or commercial success involve risks such as competition from new technologies or changes in healthcare spending patterns. Additional risk information can be found on Johnson & Johnson’s investor website or filings with regulators.
For further information on PAD prevalence:
- Global statistics on PAD can be found at https://www.ahajournals.org/doi/full/10.1161/CIRCOUTCOMES.120.007539#core-R1-1.
- European data on vascular diseases are available via https://ehnheart.org/about-cvd/the-burden-of-cvd/.
- Information on PAD from U.S. health authorities can be accessed at https://www.cdc.gov/heart-disease/about/peripheral-arterial-disease.html.