Intravascular lithotripsy (IVL) is a pioneering treatment for calcified plaque in the coronary and peripheral arteries. The technology behind IVL has been FDA-cleared to treat peripheral arteries since 2016, and to treat coronary arteries since 2021.(1) Today, exciting new advances in IVL are improving treatments and outcomes, and paving the way for the next generation of IVL procedures and techniques. In this article we take a look at some of the most promising recent advances in IVL technology and practice.

The Promising Future of Intravascular Lithotripsy 

Current endovascular treatment methods like balloon angioplasty, stenting, and atherectomy are often ineffective against complex artery diseases defined by hard medial calcium. Intravascular lithotripsy is at the forefront of the interventional landscape, showing immense promise for the future.

Shockwave Medical has been the biggest innovator in the IVL space to date, pioneering IVL’s peripheral and coronary applications. Today, younger companies like Fastwave Medical, a clinical-stage IVL startup, are leading the charge to continuously improve and elevate IVL. There is a concentrated effort across the industry to refine IVL technologies and broaden the potential applications of IVL. Key areas of focus include addressing challenges like treating long, profuse calcium and extending the scope of treatment.

This article gives a look at some of the leading IVL products and IVL companies like Shockwave and FastWave Medical. You can learn more about IVL’s current indications and uses in this article.

Areas for Improvement in Current IVL Technology

IVL systems have proven to be important innovations in managing vascular calcium, but there is still plenty of room for improvement. Feedback from leading interventional physicians has revealed issues with the deliverability and crossability of existing IVL catheters, especially for coronary applications. This means the balloon may have difficulty tracking through tortuous, diseased anatomy. This imposes a significant limit on the treatment's effectiveness, suggesting a need for new and enhanced delivery solutions. 

Interventionalists have also expressed a desire for longer-length balloons and the ability to deliver a greater number of therapeutic pulses with a single device, allowing for a more comprehensive treatment. In addition, current IVL catheters fail due to balloon rupture at a rate of 10-20%. This is a relatively high failure rate considering the high cost of current IVL devices, and should be improved upon in the coming years.

Innovations in IVL Systems are Advancing the Treatment of Calcified Arteries

IVL procedures have proven to be a safe, effective way to treat calcified lesions, even when dealing with the toughest, hardest plaque.(2) This article breaks down step-by-step what happens during an IVL procedure. Despite the success of IVL in treating plaque in the coronary and peripheral arteries, companies like FastWave Medical are continuing to innovate in the hopes of improving outcomes and lowering IVL costs.

Advancing the Capabilities of IVL Catheters and Balloons is Crucial

One of FastWave’s focus areas is enhancing the capabilities of IVL catheters. There are several areas of IVL catheter design that can be improved upon, including optimizing the shaft for better pushability. Using a differentiated balloon design could also improve rupture resistance, which is crucial when dealing with hard, jagged calcium deposits. FastWave is also working to improve the energy delivery within the balloon, which could lead to more consistent and predictable sonic output, giving physicians ever more control over the results of IVL treatments.

A Slimmer, More Durable IVL Balloon Could Make it Easier to Treat Calcified Arteries

Creating a slimmer profile for IVL balloons has the potential to be a major treatment advance, making it easier to cross heavily calcified arteries and position the device in the optimal location for treatment of hard plaque. Developing longer, more rupture-resistant balloons could also improve IVL outcomes. Today, there are a limited number of balloon sizes available for IVL procedures, which rupture at reasonably high rates, limiting its utilization in long, diffuse vascular disease.

Improving IVL System Usability to Help Physicians

Existing IVL systems can be improved, especially when it comes to usability by physicians. FastWave is trying to improve IVL catheter performance by increasing the number of energy pulses available to medical professionals during a treatment. More pulses could lead to a more effective modification of the plaque and a more successful treatment of CAD or PAD. 

FastWave is also developing a more user-friendly generator interface that delivers real-time, intra-procedural information to interventionalists. For example, current systems only display the number of energy pulses that have already been used; FastWave’s interface improves upon this limitation so physicians can strategize how to best distribute available shock waves.

Currently, IVL systems are DC-powered by battery, and cannot be used while recharging. This leads to gaps in care when IVL systems are unavailable. Existing IVL systems also rely on cumbersome reusable cables to connect the generator to the catheter. These dongles are often thrown away, leading to hassle and lost time for medical professionals and patients. FastWave’s IVL systems are aimed at solving for some of these usability gaps while also providing physicians more therapy activation options.

Potential Future Uses of IVL are Under Investigation

The medical community is hoping to broaden the approved applications of IVL beyond only the coronary and peripheral arteries in the coming years. Other potential uses for IVL that are being investigated and explored include interventions involving the major arteries of the aortic arch as well as structural heart applications. New research is even showing that IVL has the potential to aid in transvenous lead removal.(3)

To ensure patient safety, IVL should never be used for purposes beyond its specific approved indications. Today, those indications remain solely the modification of plaque in the coronary and peripheral arteries.

Improving IVL Will Brighten Its Future

In the IVL field, some areas still warrant improvement to reach the full potential of the technology for patients. Ongoing research and development play a crucial role in addressing existing challenges, which can further strengthen IVL's position as a preferred treatment for patients with calcified plaque in both coronary and peripheral arteries.

The next generation of IVL advances will not only aim to improve performance, but should also seek to improve the technology’s safety profile. Today, IVL has established itself as a safe, effective treatment for CAD and PAD with minimal complications. Further improving safety and outcomes, and minimizing risks and complications for patients, will always be a top priority for leading IVL companies. You can learn more about IVL’s strong safety profile in this article.