Johnson & Johnson has announced the European launch of its Shockwave Javelin Peripheral IVL Catheter, an intravascular lithotripsy (IVL) platform aimed at addressing calcium buildup in severely narrowed blood vessels.
This launch is expected to broaden treatment options for patients affected by peripheral artery disease (PAD).
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The Forward IVL platform features a catheter equipped with a single lithotripsy emitter positioned directly behind the tip of the device.
This design offers a safety and effectiveness profile comparable to that of the established Shockwave IVL catheters, stated the company.
PAD is characterised by the narrowing or blockage of blood vessels that supply blood to the legs. This condition leads to reduced blood flow, which can cause debilitating symptoms, ulcerations, and a heightened risk of amputation.
The Javelin Forward IVL platform is specifically engineered to address calcified occlusive disease or severely narrowed lesions where a guide wire can pass, but other devices may struggle.
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By GlobalDataThe Shockwave Javelin boasts a working length of 150cm and is equipped with a single distal emitter capable of delivering 120 shock waves. These spherical ultrasonic acoustic pressure waves extend beyond the catheter’s tip.
Its design facilitates the delivery of lithotripsy closer to occlusive calcific lesions than what is achievable with traditional balloon-based platforms.
Despite the complexities associated with the patients and calcified lesions involved in the study, the clinical outcomes from the FORWARD PAD IDE trial revealed that the Shockwave Javelin exhibits a safety and effectiveness profile comparable to that of balloon-based Shockwave IVL catheters, stated the company.
Shockwave Medical’s chief medical officer Nick West said: 鈥淪hockwave is at the forefront of IVL technology, and we continue to address unmet physician needs.
鈥淲e 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.
鈥淲e 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鈥檚 expected from IVL technology in the reduction of risks associated with CLTI.鈥�
IVL utilises energy to generate ultrasonic acoustic pressure waves, which effectively modify, fracture, and fragment vascular calcifications.
When paired with the Shockwave E8, Shockwave L6, and Shockwave M5+ IVL catheters, the introduction of the Shockwave Javelin Peripheral IVL catheter provides physicians with a comprehensive portfolio for treating complex calcified lesions throughout the entire peripheral anatomy, both above and below the knee, the company added.
