Johnson & Johnson Launches Javelin Forward-Facing Intravascular Lithotripsy Catheter in Europe for Peripheral Artery Disease

Johnson & Johnson announces the launch of peripheral in EuropeIntravascular Forward Shock Wave Catheter---Javelin，Aimed at improving calcified lesions in extremely narrow blood vessels, providing a new treatment option for patients with peripheral artery disease (PAD). This follows the FDA approval in the first half of the year.JavelinAnother milestone later.

Expert Evaluation

"The Shockwave Javelin peripheral IVL catheter is expected to address the most stubborn technical barrier in below-the-knee (BTK) revascularization—calcified lesions that 'devices cannot cross.'"

---Narayanan Thulasidasan  King’s College London

"In the past, there was a lack of reliable treatment options for non-crossable infrapopliteal vessels. Javelin fills a significant gap in the treatment of CLTI for patients with complex multi-segment lesions."

---Ashish Patel  King’s College London

Executive Assessment

"Shockwave has always been at the forefront of IVL technology development, continuously addressing unmet clinical needs. Through in-depth exchanges with the physician community, we have gathered valuable clinical insights, ultimately developing this pioneering forward IVL platform capable of modifying calcified lesions and navigating extremely narrow vessels. We are proud to set a new standard in the field of vascular intervention, expanding our product portfolio to help interventional physicians address unmet needs and push the boundaries of current IVL technology in reducing CLTI-related risks."

---Nick West  Chief Medical Officer of Shockwave Medical

Peripheral Artery Disease (PAD) refers to the narrowing or blockage of blood vessels that supply blood to the lower limbs, leading to reduced blood flow, debilitating symptoms, ulcers, and an increased risk of amputation. PAD not only impairs quality of life but also significantly raises the risk of myocardial infarction or stroke. Globally, over 230 million people suffer from PAD, with approximately 15 million individuals aged 45 and above in Europe affected by this condition. Critical Limb-Threatening Ischemia (CLTI), the most severe end-stage of PAD, impacts nearly 25 million patients worldwide. Within one year of diagnosis, the major amputation rate for CLTI reaches 40%, and the five-year mortality rate is as high as 50%, with a prognosis even worse than most cancers.

JavelinIt is a new type of shockwave catheter, which is different from the traditional balloon-type shockwave catheter mainly in that it has no balloon, andThe shock wave generator is set at the distal end of the catheter, thereby achievingTransmit shock waves to the front of the catheter, using shock waves to open occluded blood vessels.

• The pressurized chamber can be filled with saline to achieve the predetermined treatment pressure.

• Flushing the catheter lumen allows for irrigation of the treatment area with saline solution;

• The guidewire lumen is used for passing through aA 0.014" (0.36 mm) guidewire to facilitate passage through occluded vessel segments under guidewire guidance.