Shockwave Medical has introduced the Shockwave Javelin Peripheral IVL Catheter in the United States. This innovative intravascular lithotripsy (IVL) platform is designed to modify calcium and navigate through severely narrowed vessels in patients with peripheral artery disease (PAD).
The new device expands the company’s IVL portfolio and maintains the established safety and effectiveness of previous Shockwave IVL catheters.
PAD is a condition where blood vessels carrying blood from the heart to the legs become narrowed or blocked, reducing circulation. It affects more than eight million people over the age of 40 in the United States.
In its most severe form, known as chronic limb-threatening ischaemia (CLTI), PAD leads to serious complications, including a high risk of amputation and mortality rates worse than many forms of cancer.
Treating complex calcified lesions in narrowed peripheral vessels remains a challenge for physicians. There is an increasing need for improved treatment options.
The Shockwave Javelin IVL catheter is designed to assist in these cases by modifying calcium deposits and crossing heavily narrowed vessels where standard devices may struggle.
The catheter has a working length of 150 centimetres and features a single distal emitter capable of delivering up to 120 shockwave pulses. Each pulse generates a spherical energy field that reaches calcium deposits more effectively than balloon-based platforms.
The FORWARD PAD IDE trial, which evaluated the device, demonstrated that it has a comparable safety and effectiveness profile to balloon-based IVL catheters.
The introduction of this new technology aims to improve procedural efficiency and optimise outcomes for patients, particularly those with complex CLTI.
The launch of the Shockwave Javelin Peripheral IVL Catheter marks a significant advancement in the treatment of complex calcified lesions, reinforcing Shockwave Medical’s commitment to innovation and improved patient care.
