This advertorial is sponsored by Shockwave Medical.
Three vascular surgeons discuss how and when they deploy the transformative Shockwave Javelin first-of-its-kind Forward Intravascular Lithotripsy (IVL) Platform in cases of heavily calcified peripheral vascular occlusive disease.
Viewpoints on when and how to use Shockwave Javelin vary, but one insight unites them: prior to its emergence there were limited options available to get through the sorts of severely calcified lesions the device opens up. Or, as Sung Yup Kim (Mount Sinai Health System, New York, USA) puts it: “In the past we have used balloons, we have used orbital atherectomy, cutting balloons with no major success, nothing would track in these areas, and there were cases where we just had to abort and think about an open option. Shockwave Javelin allows us to deliver endovascular therapy for these patients.”
Paul Foley
“At the outset, how we thought we were initially going to use Shockwave Javelin is not how it has turned out to be.” The words of Paul Foley (Doylestown Hospital, Doylestown, USA) as he assesses the evolution in his use of the Shockwave Javelin, from initial study in the FORWARD PAD investigational device exemption (IDE) trial, through limited market release and, earlier this year, the launch of the platform in the USA. Understanding now what the device can do, Foley sees Shockwave Javelin as a routine IVL delivery device in tibial vessels and below the ankle, which is also able to tackle some of the most challenging disease.
That broader canvas for the Shockwave Javelin platform includes use as a primary IVL modality. In the limited market release phase of Shockwave Javelin, the conventional wisdom went that “if you had a boulder of calcium that you couldn’t get across, this was going to be the savior device,” Foley explains. “And, certainly, that’s one piece of Shockwave Javelin.”
However, after more experience Foley has found Shockwave Javelin’s role to be more nuanced and depends on the vessel bed, he says. In the femoropopliteal space, the Shockwave Javelin works best as facilitator, “modifying calcium to facilitate the next step”. In the tibial vessels, Foley continues, a good outcome is defined as successfully crossing the lesion while delivering pulses. “I don’t see Shockwave Javelin simply as a method of crossing the uncrossable anymore; I see it as way more than that. When I look at a calcified, highly stenotic tibial vessel, Shockwave Javelin is now my knee-jerk device.” Below the ankle, Foley says, the Shockwave Javelin is breaking new ground by effectively crossing through vessels previously unpassable by any other method.
Shockwave Javelin is proving to be a multi-tool for patients with CLTI, he adds. While vessel bed may vary, the success of the product lies in modifying plaque while achieving luminal gain and a reduction in diameter stenosis—and doing so safely without a high risk of angiographic complications, perforation or distal embolisation.1
Kenneth Tran
For Kenneth Tran (Stanford Health Care, Stanford, USA), Shockwave Javelin first and foremost has proven an important precursor in complex cases. “It’s not intended to be used as the primary IVL technology—I think of it as enabling me to do my next step in my treatment algorithm, where I can’t deliver the device I’m trying to deliver,” he says. In below-theknee (BTK) lesions, Tran sees its use as often initial vessel prep, such as to advance an intravascular ultrasound (IVUS) catheter or Shockwave E8 IVL balloon. However, he recognises instances in which Shockwave Javelin has a role to play as the go-to IVL catheter. “For isolated lesions that are very small, I have had success using the Shockwave Javelin as the sole lithotripsy device,” says Tran.
Sung Yup Kim
On the other hand, Kim sees Shockwave Javelin make the biggest difference in his practice in cases involving the femoropopliteal vessel bed. These patients will tend to have either a low segmental chronic total occlusion (CTO) or a couple of focal areas where no devices will track, he explains.
“These are cases where we already have a wire through, there is a rock sitting there, and, with Shockwave Javelin on that spot, we crack open the area, apply some forward pressure, and then try to crack the calcium distal to that. We maintain Shockwave Javelin for one or two cycles in one spot that is really, really calcified and heavy. Then, in the next few cycles, we are moving forward with Shockwave Javelin.”
Kim doesn’t see the platform as a crossing device. “It is not a case of when you can’t go through a CTO, and you use Shockwave Javelin and try to tunnel a channel through severe calcium,” he says. “I don’t think that’s the purpose of Shockwave Javelin.” Kim tends to encounter trouble with femoropopliteal lesions most often at the Hunter’s canal, where the artery sometimes bends at the popliteal facia. “If you have a severe calcium there, the bend is a killer with a rock-hard calcium,” Kim says.
Step forward Shockwave Javelin: in this small portion of cases, too, the device has proven successful, he adds.
Access points
Views on optimal access vary. While Kim prefers a contralateral approach for precision to traverse tough lesions, both Foley and Tran err toward an antegrade access.
“If there is no inflow disease, no disease in the common femoral artery, no disease in the femoropopliteal region that I think is significant, so that going in there is going to be a high likelihood I’m doing a below-knee or a tibial or even a pedal artery intervention, I approach all of those cases from an antegrade approach,” says Foley. “And I don’t have any hesitation to do that because I believe that, with an antegrade approach for below the knee, especially for calcified lesions, really stenotic or at least occlusive lesions, you have a much better chance of getting across them. You get much better pushability and tactile feedback than you would if you were going up and over from a contralateral approach. “But in any patient in whom I’m doing an antegrade approach where I know I’m going to be working below the knee, I always have the foot prepped out so that I have a low threshold of approaching from a retrograde pedal access as well.”
Shockwave Javelin provides more flexibility in terms of the level of support available while across a lesion, Tran says. In the BTK space, the antegrade approach allows for more pushability, but some anatomically inappropriate patients enforce the up-andover access of the contralateral approach, he adds.
The platform is a unique tool that can be used to modify calcium previously beyond what was available in his PAD toolkit, Tran says. “This has enabled treatment of more complex tibial lesions from an up-and-over approach. It has also allowed us to be able to treat more complex lesions more thoroughly with larger profile devices.”
Reference
- Corl J et al. FORWARD PAD IDE/feasibility studies: Primary endpoint analysis of a novel non–balloon-based peripheral IVL catheter. J AmColl Cardiol Intv. 2025 Feb, 18 (3) 398–399.
Updated safety information for the Shockwave advertorial: In the US: Rx Only. Prior to use, please reference Instructions For Use for information on indications, contraindications, warnings, precautions, and adverse events. www.shockwavemedical.com/IFU
Dr. Foley, Dr. Kim and Dr. Tran are paid consultants of Shockwave Medical, the views expressed are of their own opinions, reflect their daily medical practice and do not necessarily represent Shockwave Medical. SPL-78322 Rev. A
