Exploring major trends as IVL keeps evolving
Advances in calcified coronary plaque modification are increasingly centered on intravascular lithotripsy (IVL) because the technology reduces the risk of complications such as vessel trauma and perforation compared to more traditional techniques. Cardiovascular Business spoke with interventional cardiologist Samin K. Sharma, MD, director of the Mount Sinai Fuster Heart Hospital Cardiovascular Clinical Institute, about keys trends and advances in IVL.
While Shockwave Medical was the only IVL vendor with a U.S. Food and Drug Administration (FDA)-approved device for many years, that changed when Boston Scientific announced it had commercially launched its FDA-cleared IVL system for peripheral artery disease (PAD). There is also a growing pipeline of IVL devices from other companies.
Shockwave's chief medical officer, Nick West, MD, said his company's IVL system is now used in more than 10% of coronary procedures in the U.S. Atherectomy is still more widely used due to cost and anatomical considerations, Sharma noted, though the two technologies are also regularly used together.
IVL uses acoustic energy to fracture calcified plaque at low balloon pressures, which helps lower the risk of vessel perforation. Sharma said the technology “works very well,” but Shockwave's high cost is the main factory limiting wider adoption.
“It’s about $4,700, since it’s the only device in the market,” Sharma said, adding that current reimbursement does not fully cover the device cost. However, he said the price point may decrease from competition as more IVL companies enter the market.
New IVL devices working toward commercialization
While rotational, orbital and laser atherectomy all remain established tools, Sharma noted that most development today involves only small, incremental changes. By contrast, IVL has seen rapid growth and innovation since its initial introduction by Shockwave. Sharma pointed to numerous IVL devices now in development, including two already being actively used in India.
Newer IVL technologies aim to address the key limitation of current systems, which is deliverability in very tight or totally occluded lesions. Sharma said Shockwave's recent launch of the balloon-free Javelin catheter with an acoustic emitter on the tip may help in this area. He also highlighted several investigational devices, including Fastwave's laser-based IVL platform that is currently being studied for a clinical trial at Mount Sinai and other sites. Other companies, including Abbott and Amplitude Vascular Systems (AVS), are exploring alternative mechanisms to deliver acoustic or sound-wave energy to fracture calcium using lower-profile catheters.
“The advantage will be more and more cases of the calcium lesions can be done without using atherectomy,” Sharma said.
Use of rota-shock procedures in tight lesions
Despite IVL optimism, Sharma emphasized that atherectomy continues to play an important role, mainly in tight lesions IVL catheters cannot cross. In those cases, operators may use a combined approach, sometimes referred to as “rota-shock,” where limited rotational atherectomy is performed first to allow IVL catheter entry.
"In almost 30–40% of cases we have to do atherectomy to get the IVL catheter in,” Sharma said of the experience at his center. He expects this number decline as lower-profile IVL devices become available and costs drop.
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]