Shockwave’s novel Javelin intravascular lithotripsy catheter focuses acoustic energy forward to clear a path through calcium-clogged blood vessels.
Shockwave Medical designed the Javelin peripheral intravascular lithotripsy (IVL) catheter to break up calcium in blood vessels through which previous IVL devices could not pass. [Illustration courtesy of Johnson & Johnson MedTech]
Johnson & Johnson MedTech’s Shockwave Medical aims to deliver intravascular lithotripsy (IVL) to a different type of blood vessel with a first-of-its-kind catheter platform.
The Javelin Peripheral IVL catheter features new technology for modifying calcium and crossing extremely narrowed vessels in patients with peripheral artery disease (PAD).
Shockwave says the novel, non-balloon IVL platform delivers a similar safety and efficacy profile as its legacy catheters, bolstering the device developer’s market-leading IVL portfolio.
“We believe this technology has the ability to transform the way that physicians are able to treat patients with peripheral vascular disease,” Shockwave Chief Medical Officer Dr. Nick West said in a Medical Design & Outsourcing interview. “We hope that we’re answering a clear unmet need not just from physicians, but from the patients they also serve.”
Shockwave’s IVL technology
The Shockwave Medical Javelin peripheral intravascular lithotripsy (IVL) system [Image courtesy of Johnson & Johnson MedTech]
Shockwave’s IVL technology uses acoustic energy to treat calcified narrowings in blood vessels. It’s an adaptation of extracorporeal shockwave lithotripsy used to treat kidney stones, but miniaturized and tuned for use inside blood vessels.
Shockwave IVL sparks an electrical current between two electrodes, traditionally encased in a balloon placed in the blood vessel. The spark enables the formation of a vapor bubble in the mixture of contrast and saline within the balloon. As the bubble collapses, it emits an acoustic pressure delivered to the tissues.
The Javelin system doesn’t have a balloon, however. It has a single emitter behind the tip of the catheter, designed to create acoustic pressure waves in the same way the balloon-based catheter does, according to West. That 120-pulse lithotripsy emitter helps enable use in sub-total occlusions or extremely narrowed vessels through 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, which has a working length of 150 cm. This approach allows modification of the obstructive calcification that facilitates device crossing.
What difference does Javelin make?
Shockwave Medical Chief Medical Officer Dr. Nick West [Photo courtesy of Johnson & Johnson MedTech]
In track and field, the javelin event can sometimes be viewed “as a kind of brute force event,” West said, but javelin throwers often aren’t “the biggest and most muscular guys.”
Similarly, Shockwave’s Javelin is “not all about brute force to get this through the lesion.”
“It’s partly about the technique,” he said, “but also we hope that it encapsulates that ability to cross those very, very difficult lesions and also modify them on the way.”
In an FDA investigational device exemption (IDE) study, Javelin’s results “closely mimic those of our balloon-based platforms, showing excellent safety and efficacy in modifying calcium and allowing the crossing of these lesions,” West said.
The big difference without a balloon is that the catheter is more deliverable, West said. And physicians are already familiar with microcatheters and catheter-based technologies for treating complex lesions, so Javelin’s design is immediately familiar to them. Additionally, the Javelin emitter is similar to those in the Shockwave balloon platform.
Effectively, the system can deliver lithotripsy capable of breaking up calcium a physician couldn’t reach with the balloon-based system.
“We transitioned that emitter technology from the balloon-based platform to this new forward IVL platform, but we’ve replicated the same efficacy and safety as that prior parent platform,” West said.
While estimates vary, West said as many as 12 million people in the U.S. have peripheral vascular disease, with many more cases globally, leaving many at risk of losing limbs and possibly their lives through heart attack or stroke. The most severe form, chronic limb-threatening ischemia (CLTI), brings even more risk.
“There is a real need to be able to treat these patients,” West says. “Endovascular treatments are not the only option available to these patients. But, should an endovascular approach be used, given the prevalence of calcification, we think this tool could really be a difference-maker in those patients that are very difficult to treat.”
