Shockwave Medical unveils first clinical outcomes of new IVL catheter platform

Shockwave Medical, Inc., part of Johnson & Johnson MedTech and a global leader in the field of circulatory restoration, announced today the first clinical outcomes associated with the Shockwave Javelin Peripheral IVL Catheter, a novel, non-balloon-based lithotripsy platform designed to modify calcium and cross extremely narrowed vessels in patients with peripheral artery disease (PAD). Despite the challenging nature of the calcified lesions studied, the 30-day results met both prespecified performance goals while showing a similar safety and effectiveness profile to balloon-based Shockwave IVL catheters. 

The Shockwave Javelin Peripheral IVL Catheter is a novel, non-balloon-based device that features a single 120-pulse lithotripsy emitter at the distal tip of the catheter. It is designed for use in sub-total occlusions or extremely narrowed vessels in which a wire will cross but devices will not. With this new platform, the sonic pressure waves expand spherically from the forward-shifted emitter beyond the tip of the catheter, allowing modification of the obstructive calcification that facilitates device crossing. 

The Shockwave Javelin Peripheral IVL Catheter met both prespecified safety and effectiveness endpoints, with a major adverse event rate of 1.1 percent at 30 days, and a technical acute procedural success rate of 99 percent. Additionally, at final angiography, angiographic complications were restricted to a single case of dissection with no reported perforations, abrupt vessel closure, distal embolization or no-reflow.

The technology has received U.S. FDA clearance for patients with peripheral arterial disease. The results, which helped support U.S. Food and Drug Administration clearance of the technology last month, were presented as a late-breaker today at the annual Vascular InterVentional Advances (VIVA) meeting.