Intravascular lithotripsy (IVL) has proven to be a groundbreaking innovation in the treatment of calcified plaque that characterizes coronary artery disease (CAD) and peripheral arterial disease (PAD). IVL has the potential to treat difficult plaque deposits that traditional angioplasty and stent deployment are less effective against. Shockwave Medical and their technologies have played a pivotal role in shaping the IVL landscape. In this article, we’ll give an overview of the leading IVL companies and products, including Shockwave Medical and FastWave Medical. 

Shockwave Medical Has Been a Pioneer of IVL Technologies

To date, Shockwave Medical has been the leading developer of IVL technologies. Shockwave is a pioneer in the IVL field, and they have also been a critical collector of clinical data to advance and legitimize IVL procedures. Shockwave’s IVL devices, which the company has designed for both PAD and CAD interventions, have significantly advanced the treatment of calcified plaque. This article goes into more detail about how cholesterol buildup can lead to calcified plaque in the arteries and cause PAD and CAD.

The Shockwave IVL system with the Shockwave C2 coronary IVL catheter is indicated in the U.S. for lithotripsy-enabled, low-pressure balloon dilatation of severely calcified, stenotic de novo coronary arteries prior to stenting and has been commercially available since early 2021. (1,2) The company’s lineup of IVL catheters for the treatment of peripheral arterial disease has been FDA-cleared since 2016.

Shockwave Medical offers a diverse product range, including a notable IVL system tailored to address calcified coronary and peripheral artery disease. However, even groundbreaking solutions require considerations, and can be improved upon as technology and patient care continue to advance. Shockwave Medical's IVL devices, while transformative, come with specific nuances and limitations that warrant further attention and innovation.

Areas for Improvement in Current IVL Technology

Current IVL systems have proven to be important innovations in managing vascular calcium, but there is still plenty of room for improvement. Existing IVL devices face difficulties addressing extended-length segments of calcium in the peripheral and coronary arteries. Treating these profuse, hardened deposits is critical to expanding upon IVL’s success in CAD and PAD. If you're curious what happens during an IVL procedure, check out this article for a step-by-step IVL procedure breakdown.

Feedback from leading interventional physicians has revealed issues with the deliverability and crossability of existing IVL catheters, especially for coronary and below-the-knee applications. Bulky balloons are difficult to navigate through tortuous, diseased anatomy, and current IVL balloons rupture too frequently. For example, Shockwave’s 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 existing IVL devices, and imposes a significant limit on the treatment's effectiveness.

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. There are also usability concerns with current IVL systems, which only display how many pulses have been used, and require a cumbersome reusable connector cable. Increasing the amount of real-time, intra-procedural feedback available to physicians and streamlining the use of IVL systems are just a few of the improvements that cardiovascular physicians are looking for.

Finally, a major concern and area for improvement with current IVL systems is cost. IVL systems can entail substantial costs for healthcare systems and their patients compared to traditional treatments. Bringing down IVL costs to facilities and patients should be a leading priority in the years ahead. If you’re curious about the reimbursement landscape for IVL procedures, this article provides more details.

Shockwave’s Advances Have Paved the Way for New IVL Technologies and Procedures

Mentioning the challenges and limitations of current IVL devices does not diminish the remarkable achievements Shockwave has made bringing IVL to the forefront. Rather, they have served as a catalyst for ongoing research and outside innovation by other companies. Building on the momentum of Shockwave’s devices have been a number of promising IVL-focused startups. 

FastWave Medical is Developing Innovative IVL Solutions for Treating Calcified Plaque

FastWave Medical is one rapidly growing medical device company making strides in the IVL space. Building on the pioneering work of Shockwave Medical, FastWave Medical is carving a niche in the IVL space with a differentiated approach that addresses existing gaps in IVL treatment. FastWave’s technologies are not yet approved for patient use, but the company is planning to offer IVL innovations that aim to improve patient care and lower costs. 

FastWave’s approach starts with improving the design and capabilities of IVL catheters. There are several areas of IVL catheter design that can be improved upon, including optimizing the catheter shaft for better pushability. Using a differentiated design for the balloon could also improve rupture resistance, which is crucial when dealing with the most challenging calcium deposits.

Current IVL systems cap the amount of energy available for a procedure. 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 working to improve the way energy is delivered inside the balloon catheter. More durable energy delivery could lead to more consistent and predictable sonic output, giving physicians ever more control over the results of IVL treatments.

In addition to the introduction of various new rupture-resistant balloons, which could equate to safer procedures with fewer potential complications, FastWave hopes to improve the crossability of the catheters as well, which is crucial for navigating complex vascular structures.

A slimmer IVL balloon would make it easier to cross heavily calcified arteries and position the device in the optimal location. Developing longer balloons could also improve IVL outcomes due to the limited number of balloon sizes available for IVL procedures.

FastWave is developing a more user-friendly generator interface that delivers real-time, intra-procedural information to medical professionals with more therapy activation options. To learn more about how FastWave is advancing IVL, check out this article.

Conclusion: FastWave is One of the Startups Advancing IVL

IVL systems have only been available for patient use for 7-8 years. In that time, Shockwave Medical has been the leading company in the field, offering both coronary and peripheral IVL systems. Today, FastWave Medical is a promising company pioneering new approaches that address existing gaps in IVL treatment, like catheter design, energy delivery, usability for physicians, and cost. IVL technology is advancing rapidly and the coming years show immense potential for this innovative treatment.