Today, Shockwave Medical announced the U.S. launch of its Shockwave Javelin peripheral intravascular lithotripsy (IVL) catheter, a platform designed to modify calcium and cross narrowed vessels in patients with peripheral artery disease (PAD).
The platform is designed to modify calcium and cross calcified occlusive disease or extremely narrowed lesions where a wire will cross but devices might not.
Shockwave Javelin has a working length of 150cm and features a single distal emitter that creates up to 120 shockwave pulses. Each shockwave pulse creates a spherical energy field that extends beyond the tip of the catheter. This novel design delivers lithotripsy closer to calcium than the balloon-based platform, the company reports.
Despite the challenging nature of the calcified lesions studied, the clinical outcomes from the FORWARD PAD investigational device exemption (IDE) trial demonstrated that Shockwave Javelin has a similar safety and effectiveness profile to balloon-based Shockwave IVL catheters, a press release states.
