Why Shockwave Medical is so excited about the future of intravascular lithotripsy
Shockwave Medical, a part of Johnson & Johnson MedTech, continues to expand the scope of intravascular lithotripsy (IVL) as adoption of the technology grows across coronary and peripheral interventions, according to Nick West, MD, the company's chief medical officer.
West said IVL has rapidly moved from a niche therapy to a routine tool for treating complex calcified disease. “From the launch around 2017, certainly in the coronary space, we saw an uptick from zero to nearly 7% in only a year and a bit. And now we're north of 10% penetration in the coronary procedures,” he said, noting that this figure does not include peripheral use. He added that Shockwave recently marked a major milestone, with 1 million patients treated, calling it “a hell of a milestone for eight years in use.”
A key driver of that continued growth is the company’s focus on innovation driven by physician feedback.
“At Shockwave, we have a culture of innovation,” West said. “We are committed to delivering patients the best treatments, and that means listening to their physicians and their needs, which we need to then work on and give back to them.”
One of the company's most significant recent developments is the Javelin catheter, a first-in-class, non-balloon-based IVL device designed for lesions that are not crossable or vessels that are occluded. West explained that the catheter has a single lithotripsy emitter identical to those in the company's balloon-based platforms, but it is just behind the tip of the device. This design allows clinicians to place the emitter directly against heavily calcified lesions to treat patients that would not otherwise have been treatable. The device has completed a study presented as a late-breaking trial and is now available for peripheral use, while a coronary IDE study, the Forward CAD trial, is ongoing.
On the coronary side, Shockwave is also advancing its next-generation balloon-based platform with the C2 Aero catheter. West said feedback on earlier devices centered not on efficacy but on deliverability and ease of use.
“We've listened very carefully to physicians about the issues they have with the IVL device,” he said. “So we've made a new tip on the device. We've got a new balloon material. We've got a flexible shaft and a hydrophilic coating.”
Early experience from a limited market release has been positive, and West said the design improvements should help expand IVL use to a broader range of lesions.
Looking ahead, West emphasized that Shockwave’s research and development pipeline extends beyond coronary and peripheral interventions.
“What I can say is that we have more devices coming out for use in the structural heart space, and probably next year sometime we will see the start of a clinical trial looking at a dedicated device in the carotids,” he said.
West also highlighted ongoing programs exploring IVL for valvular applications.
“We have programs in both aortic and mitral. We're very excited about these possibilities,” he explained, adding that valvular calcification remains a major challenge for transcatheter valve therapies.
Despite increased interest from potential competitors, West expressed confidence that Shockwave will maintain its leadership position.
“We are leading the space. We are the only player at the present time. We have no intention of giving up that position,” he said.
He pointed to the company’s extensive evidence base, noting it has more than 600 published papers and more than 20,000 patient outcomes supporting Shockwave's IVL platform.
West said that combination of clinical evidence, sustained R&D investment, and physician-driven design will be critical as IVL expands into new indications.
“We are enthusiastic,” he said, adding that Shockwave aims to continue “to build on a compelling and comprehensive evidence base with novel and innovative disruptive technologies to service the needs of patients with calcific coronary disease and peripheral vascular disease.”
Dave Fornell has covered healthcare for more than 17 years, with a focus in cardiology and radiology. Fornell is a 5-time winner of a Jesse H. Neal Award, the most prestigious editorial honors in the field of specialized journalism. The wins included best technical content, best use of social media and best COVID-19 coverage. Fornell was also a three-time Neal finalist for best range of work by a single author. He produces more than 100 editorial videos each year, most of them interviews with key opinion leaders in medicine. He also writes technical articles, covers key trends, conducts video hospital site visits, and is very involved with social media. E-mail: [email protected]