New balloonless IVL catheter offers an alternative to atherectomy in tight lesions, CTOs
Shockwave Medical introduced two new intravascular lithotripsy (IVL) catheters at TCT 2024 for the treatment of peripheral artery disease (PAD) and critical limb ischemia (CLI). The Javelin is a new non-balloon based IVL platform with a forward-facing emitter for treating tight lesions and chronic total occlusions (CTOs). It will be offered as new alternative to atherectomy. The new E8 catheter, meanwhile, has 8 emitters to treat longer vessel segments with greater speed.
Cardiovascular Business spoke with J.D. Corl, MD, medical director of the PAD/CLI program at The Christ Hospital in Cincinnati, to discuss his experience using both catheters. He said they are an upgrade from the previous-generation IVL catheters. The Javelin, he added, stands out for its departure from traditional balloon-based technology and previous IVL catheters, utilizing a forward-focused emitter positioned near the catheter’s tip.
"The Javelin catheter is a non balloon-based lithotripsy catheter with a forward facing, single emitter that will actually affect the calcium in front of the catheter and allow it to cross lesions that are difficult to cross, or are uncrossable, due to calcium. It allows you to get through caps and proximal calcified stenosis that you couldn't previously cross, or had difficulty crossing," Corl explained.
He said CTOs or severely occluded vessels are very common in the tibial vessels, but this new catheter facilitates passage with reduced risk of trauma.
The E8 catheter builds on Shockwave’s earlier models, featuring a longer treatment segment with eight emitters and a shaft length is 150 centimeters. Corl said this balloon-based device provides an upgrade in both deliverability and efficacy, with its extended shaft and 400 shockwaves compared to 300 on the previous M5 Plus catheter. These features allow for greater coverage of extensive calcified areas, particularly benefiting patients with PAD who require treatment over longer arterial segments.
Corl said IVL therapy has helped reduce the need for atherectomy because it can tackle calcium without releasing emboli and provides a safer treatment.
"We obviously use atherectomy when indicated, but that usage has gone down. I think lithotripsy has given us a safe, effective way to deal with these calcium. The embolic concerns, dissections, perforations with the low inflation of that balloon and let lithotripsy do the work, as opposed to a high pressure balloon inflation trying to get your lumen gain. It's a lot safer in my opinion, especially up in the iliacs. We're talking about those large vessels where you really don't want an issue up there. So it's been a nice addition compared to the old balloon angioplasty, and it's just doing the same work at lower atmospheres and less risk," Corl explained.
He has used Shockwave's IVL technology since it first gained FDA approval, described the devices as transformative. In his clinical experience with hundreds of cases, he reported no embolic events or perforations, risks commonly associated with traditional high pressure balloon angioplasty.
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: dfornell@innovatehealthcare.com