The system is designed to modify calcium and cross extremely narrowed vessels in patients with peripheral artery disease (PAD). Shockwave said its novel, non-balloon IVL platform delivers a similar safety and efficacy profile to its legacy catheters, bolstering its market-leading IVL portfolio.
Santa Clara, California-based Shockwave designed Javelin with a single 120-pulse lithotripsy emitter at the distal tip of the catheter. The company developed it for use in sub-total occlusions or extremely narrowed vessels. These are vessels in which a wire can cross but devices can not. With this new platform, the sonic pressure waves expand spherically from the forward-shifted emitter beyond the tip of the catheter. It allows modification of the obstructive calcification that facilitates device crossing.
Javelin has a working length of 150 centimeters. Each shockwave pulse creates a spherical energy field that extends beyond the tip of the catheter. The novel design delivers lithotripsy closer to calcium than the balloon-based platform. Shockwave last fall shared that the system met its primary endpoints in a clinical trial.
Shockwave commentary on Javelin
Last year — prior to Johnson & Johnson’s $13 billion acquisition of Shockwave — the company outlined its hopes for Javelin. Former CEO Doug Godshall said it offers an alternative to the company’s currently available balloon-based platform.
Godshall said Javelin “sort of shifts the energy to the front of the catheter for really difficult-to-cross lesions, which is a subset of patients we just really can’t treat today.”
“As the pioneer of IVL technology, our goal is to continue to deliver innovations that address the unmet needs of the physicians that we serve,” said Dr. Nick West, chief medical officer, Shockwave Medical. “By listening to and leveraging their valuable insights, we developed our transformational forward IVL platform with the unique capability to both modify calcium and cross extremely narrowed vessels.
“We are proud to be leading the charge in offering endovascular interventionalists more flexibility to address critical treatment needs and potentially reduce the risks associated with [chronic limb-threatening ischemia] for their patients.”
