Millions of people are affected by artery diseases caused by calcified plaque buildup in the coronary and peripheral arteries – especially coronary artery disease (CAD) and peripheral arterial disease (PAD). In recent years, there have been significant advances in patient care, thanks to an innovative treatment technique called intravascular lithotripsy (IVL).

IVL uses sonic pressure waves, or shock waves, to help break up the hard, calcified plaque that obstructs the arteries. In this article, we’ll cover everything you need to know about artery calcification and IVL: CAD and PAD symptoms and causes, the science and technology behind IVL, intravascular lithotripsy uses, benefits, market, and IVL’s potential to revolutionize the treatment of artery disease.

Artery Calcification Leads to Diseases Like CAD and PAD

Diseases like CAD and PAD are caused by the buildup of cholesterol in the arteries. Cholesterol is not inherently bad, but excess cholesterol can join with other substances in the blood to form a hard, thick layer of plaque inside the arteries.(1) Plaque buildup leads to the calcification of arteries, a process also known as atherosclerosis or the “hardening” or “thickening” of the arteries.(2)

As calcified plaque builds over time, it narrows the arteries and makes it more difficult for the heart and vessels to transport blood.(2) This gradual narrowing of the artery is a process called stenosis. CAD and PAD are related conditions caused by arterial plaque obstructing blood flow and increasing blood pressure.(3) CAD develops when plaque buildup in the coronary arteries blocks the flow of blood to the heart. PAD develops when plaque in the peripheral arteries blocks blood flow to tissues in the legs and feet. This article has a deeper dive on how plaque accumulates in arteries and leads to CAD and PAD. 

CAD and PAD are Leading Causes of Mortality, Affecting Hundreds of Millions Globally

CAD and PAD are common diseases experienced by over 5% of the adult population.(4) CAD is the most common type of heart disease, experienced by over 18 million American adults.(5) Approximately 8-12 million American adults are estimated to have PAD.(6) A recent systematic review estimates that the global prevalence of PAD was 5.6% in 2015, indicating roughly 236 million adults were living with PAD worldwide.(7,8)

Coronary Artery Disease Occurs When Plaque Blocks Blood Flow to the Heart

Coronary artery disease affects the coronary arteries that supply blood to the heart. With CAD, calcified plaque buildup narrows or blocks one or more coronary arteries.(9) When these arteries become narrowed or blocked, the heart muscle can't get as much oxygen as it needs, leading to chest pain, or angina. A significant portion of people with CAD will experience a heart attack, also called an acute myocardial infarction (AMI).(9) CAD can also lead to other complications like arrhythmia or heart failure. CAD is a chronic condition, and people may not experience CAD symptoms for many years as plaque gradually builds in the arteries.(9)

Symptoms of Coronary Artery Disease

• Temporary chest pain or discomfort that comes and goes (stable angina)

• More persistent chest pain (angina) that may spread to limbs, neck, and back

• Shortness of breath (dyspnea) or trouble breathing

• Feeling dizzy or lightheaded

• Heart palpitations

• Tiredness (10)

Peripheral Arterial Disease Occurs When Plaque Blocks Blood Flow to Tissues in the Legs and Feet

Peripheral artery disease is closely related to CAD and has a significant correlation. PAD affects the arteries outside the heart, especially the ones that supply blood to the legs and feet. With PAD, calcified plaque buildup narrows or blocks one or more peripheral arteries. This makes it more difficult for the blood to carry oxygen and nutrients to tissues in the feet and legs.(6,7)

PAD can cause pain, aching, and cramping with walking (known as claudication). Notably, women are more susceptible to PAD than men.(11,12) PAD can build up over many decades, and roughly half of people with PAD may not experience active symptoms until later in life. However, the presence of PAD is still an indicator of systemic arterial calcification and an increased risk of heart disease.(6,7)

Symptoms of Peripheral Arterial Disease

• Claudication (pain, cramping, and discomfort in the legs and buttocks)

• Burning or aching in the feet and toes while resting at night

• Redness or other color changes

• Skin and soft tissue infections in the feet or legs

• Persistent toe and foot sores (11)

Risk Factors for CAD and PAD Include Lifestyle Factors like Smoking and Activity Level

Plaque accumulation in both peripheral and coronary arteries is a gradual process that is strongly influenced by a person’s lifestyle. Risk factors for CAD and PAD include:

• Prolonged sedentary behavior

• Unhealthy diet with excessive cholesterol

• Smoking

• High blood pressure

• Diabetes

• Obesity

• Aging (13)

Preventing CAD and PAD: A Healthy, Active Lifestyle Helps to Limit Artery Calcification 

CAD and PAD are chronic conditions that develop gradually over a person’s lifetime. Sometimes it can take decades of plaque buildup in the arteries before a person starts feeling symptoms from CAD or PAD. Making healthy choices today can help limit plaque accumulation and lower the risk of an arterial disease developing later on. The best way to prevent artery calcification before it leads to CAD and PAD is to live an active lifestyle with a healthy diet.(6,9)

• Healthy diet: To promote arterial and heart health, it’s recommended to eat a diet that’s rich in whole foods and low on saturated fats, trans fats, cholesterol, and sodium.

• Exercise: Living a sedentary lifestyle is a major risk factor for artery calcification. Regular physical exercise improves cardiovascular health and can help manage risk factors.(6,9)

• Avoid smoking: Smoking and tobacco are major risk factors for CAD and PAD.(6,9)

People experiencing diabetes, obesity, and high blood pressure are at an increased risk of developing CAD and PAD. For people with these conditions, monitoring symptoms and scheduling regular medical checkups is especially important.

The Challenges of Treating Calcified Arteries

Calcium plaque deposits in the coronary and peripheral arteries can be difficult to treat because of their hardness. As arteries become more filled with plaque, it makes standard treatments less effective because the hardening vessel is less malleable and adaptable.(14,15)

The location of calcified plaque in the arteries is also challenging. Medial calcific plaque is positioned deeper and can be hard to reach with interventional catheters. Intimal calcium deposits are situated closer to the artery's inner surface, and can act as an obstruction, blocking blood flow and complicating treatments. As arterial plaque becomes calcified, it poses distinct challenges to drug delivery and may compromise stent expansion.(14,15)

Many CAD and PAD patients are older and have other cardiovascular risk factors like hypertension (high blood pressure), which can complicate treatments. Comorbidities are common, making a one-size-fits-all treatment approach unrealistic for arterial calcification and CAD/PAD. Managing these conditions and treating arterial calcification involves a mix of prevention, medication, and sometimes medical interventions. 

Treatments for Coronary Artery Disease and Peripheral Arterial Disease

Beyond prevention, the management of CAD and PAD with medications focuses on alleviating symptoms, stabilizing plaques, and addressing underlying risk factors that contribute to the progression of artery calcification. This article has more information about the various medications and interventional treatment approaches for CAD and PAD.

Medical Interventions for Artery Calcification Include Angioplasty and Stents

Traditional treatments for artery calcification include:

• Angioplasty: Also known as balloon angioplasty, this procedure attempts to clear blocked arteries of plaque using a balloon-tipped catheter.

• Stents: To keep a congested artery open, a scaffolding called a stent can be placed inside a vessel to relieve an obstruction.(16)

Current endovascular treatment methods like angioplasty and stenting can help, but are largely ineffective against the most complex artery diseases, especially medial calcium. Calcium makes it difficult for devices to traverse the vasculature, inhibiting stent apposition and expansion. High-pressure balloons may be used to fracture calcium and achieve luminal gain, but they may also lead to complications such as vessel dissection and perforation.

Atherectomy devices can effectively treat intimal calcium but are less effective against medial calcium and may cause embolism, dissection, and perforation. Given these limitations, there is a clear and unmet need for innovative approaches to address complex calcium plaque blockages.

Innovative Medical Procedures Have Arisen to Treat More Challenging Cases of Calcified Plaque

In some cases, calcified plaque in the arteries is more difficult to modify due to the development of intricate, napkin ring-like lesions. Hard plaque in this shape may be too difficult to clear for traditional treatments.(16) To address plaque removal challenges, innovative new medical technologies have arisen to treat calcified arteries:

• Drug-coated balloons (DCB): Medication-coated angioplasty balloons that release their drug upon inflation, reducing scar tissue formation.(17)

• Drug-eluting stents: Drug-eluting stents can prevent an artery from collapsing and are coated with medication to help ensure the vessel remains clear.(18)

• Plaque modification tools: Atherectomy devices aim to cut or grind away calcium deposits in the arteries. There are also specialty balloons equipped with elements that make precise incisions in calcified plaque, aiding in vessel expansion.

Intravascular Lithotripsy (IVL) Has Emerged as a Leading Treatment for Artery Calcification

Given the limitations of traditional endovascular options, the emergence of intravascular lithotripsy in recent years has been a groundbreaking development in the treatment of calcified plaque. IVL harnesses shock waves to target and fragment calcium deposits, both superficial and deep, while ensuring the vessel's integrity remains intact. By affecting some of the toughest arterial plaque deposits, IVL has the potential to transform the CAD and PAD treatment landscape.

Intravascular lithotripsy is an innovative, catheter-based treatment that uses sonic pressure waves, or shock waves, to break up calcified plaque deposits in the arteries. This makes IVL a critical new tool for treating both CAD and PAD. Today, IVL is specifically approved for modifying calcified plaque within the coronary and peripheral arteries. This article goes into more detail about when IVL is used, and when IVL shouldn’t be used. 

How Does Intravascular Lithotripsy Work? 

IVL works by delivering acoustic pressure waves that safely pass through soft tissue, while disrupting hard calcium. The purpose of an IVL treatment is to fracture this hard, calcified plaque to improve blood flow or optimize stent placement. The procedure involves introducing a lithotripsy catheter equipped with an integrated angioplasty balloon into the artery. Emitters within this balloon produce sonic pressure waves that focus mechanical energy on the targeted lesion, causing the hard plaque to crack without affecting the surrounding soft tissues.(19,20,21,22)

IVL technology is similar to traditional percutaneous transluminal angioplasty (PTA) and percutaneous transluminal coronary angioplasty (PTCA) devices. This familiarity makes it a more comfortable choice for professionals accustomed to using these common vascular treatment tools. A key difference with IVL systems, however, is how they generate and use pressure.

Typical angioplasty balloons often require higher pressures to expand a blocked or narrowed artery, but IVL balloons take a gentler approach and work efficiently under low pressure. By emitting sonic pressure waves, IVL can effectively break down both medial and intimal arterial calcium. As the artery is subjected to these sound waves, the calcified deposits crack and disintegrate, increasing blood flow and paving the way for subsequent interventional treatments. Intravascular imaging techniques employed during and post-treatment confirm the comprehensive disruption of the plaque.(21,22,23)

Intravascular Lithotripsy Technology 

IVL technology has its origins in a novel treatment for renal calculi, or kidney stones.(21) This was the first use case for mounting multiple lithotripsy emitters on a traditional catheter platform to deliver shock waves at a targeted lesion. In fact, intellectual property referencing the use of this technology for vascular applications goes back decades. 

Today, this same concept is used to treat calcified plaque in arteries. Modern IVL features a multi-faceted system that includes a lithotripsy catheter with an integrated angioplasty balloon that is connected to a generator. IVL equipment includes:

• IVL catheter: A single-use, sterile, disposable catheter with an integrated angioplasty balloon.

• Angioplasty balloon: Integrated within the IVL catheter, it contains multiple lithotripsy emitters.

• Energy generator: The generator powers the emitters, which generate sonic pressure waves, or shock waves.

The Science Behind Intravascular Lithotripsy

The science behind intravascular lithotripsy revolves around the use of sonic pressure waves, or shock waves, to modify hard arterial plaque. An IVL procedure generates a series of these waves inside a vessel with a plaque obstruction. These waves are specifically designed to generate mechanical energy that fragments superficial and deep-seated calcium deposits.(20) Modifying these arterial calcium deposits makes it easier to deploy other vascular therapies like atherectomy catheters or drug-eluting technologies.(21,23)

The IVL catheter, integral to this process, is designed as a single-use, sterile, and disposable instrument, emphasizing patient safety and treatment efficacy. The catheter incorporates multiple lithotripsy emitters set within an integrated balloon. These emitters produce sonic pressure waves in a spherical distribution, offering a thorough field effect to address the hard calcium lesions.

IVL Targets Arterial Plaque Without Compromising Soft Tissues

The energy from an IVL treatment creates cracks and fissures in hard plaque, while passing harmlessly through soft, fibroelastic tissues in the artery walls.(17,19) IVL has proven to be an effective way to fracture plaque without harming the vessel. This precision helps the artery to become more compliant, optimizing subsequent interventions like balloon angioplasty or stent deployment.(20)

What Happens During an IVL Procedure

The standard treatment procedure for IVL includes the following primary steps:

1. IVL catheter insertion: First, the catheter is inserted into the artery and navigated to the targeted calcified blockage. Clinicians utilize marker bands to ensure proper positioning to align the emitters adjacent to the calcified sections, thereby optimizing the therapeutic effect.

2. Device inflation: Next, the angioplasty balloon is inflated within the diseased artery.

3. Sound wave emission: Once the intravascular lithotripsy catheter is inflated, the IVL generator powers the emitters to produce sound waves targeting the calcified plaque. The generator is designed to deliver consecutive pulses at a specified rate, which creates mechanical energy that fractures calcium deposits.

4. Device deflation: After targeting the plaque with a series of sound or shock waves, the balloon is deflated and the IVL catheter is removed.

5. Imaging evaluation: Post-treatment, the use of advanced intravascular imaging techniques help assess the effectiveness of the procedure. 

This article goes into more detail about what happens during an IVL procedure.

Physicians Use Intravascular Imaging Techniques Before and After IVL Procedures

Medical professionals often use intravascular imaging techniques before and after the IVL procedure. These include intravascular ultrasound (IVUS) and optical coherence tomography (OCT), which help to assess and characterize severely calcified arteries. This imaging capability makes IVL a pivotal tool for doctors treating arterial diseases like CAD and PAD.

Improving IVL Treatment Outcomes with Intravascular Imaging

Intravascular imaging holds a pivotal role in enhancing the outcomes of treatments. The significance of imaging lies in these factors:

• Gauging calcium density: Precisely determining the calcium plaque’s density ensures that medical practitioners are well-informed about the plaque's composition.

• Selecting the right technique: By understanding the lesion's nature, clinicians can choose the most effective modification method, be it rotational atherectomy, directional atherectomy, or IVL.

• Monitoring procedure progress: Real-time imaging offers a clear insight into the ongoing treatment, enabling adjustments when necessary.

• Confirming effective treatment: Post-procedure, intravascular imaging verifies that the calcified plaque has been adequately addressed and broken down.

By incorporating intravascular imaging, medical professionals can fine-tune the treatment process, leading to shortened procedure durations and optimized results.

The Patient Experience During an IVL Procedure

IVL is typically a painless procedure for patients, aside from the discomfort of inserting a catheter. For a patient, going through an IVL procedure is similar to other catheter-based procedures like angioplasty or stent placement. IVL can be an outpatient or inpatient procedure and is usually performed in a room equipped with imaging equipment.

Treatment procedures will vary from facility to facility, but in general a person undergoing an IVL treatment can expect the following steps:

1. IVL preparation: Before the procedure, the patient will undergo a thorough medical evaluation, and will be informed about the procedure's details, potential risks, and benefits. 

2. Mild sedation and local anesthesia: Some IVL patients are given mild sedation to help them relax. Most patients remain awake during the procedure and can communicate with the medical team. Local anesthesia is often applied at the site where the catheter will be inserted.

3. Procedure: A nurse or physician will make a small puncture in the artery, typically in the groin (femoral artery). Through this entry point, a sheath is placed to allow catheters to be passed easily into the artery. Once the emitters begin to deliver sonic pressure waves, the patient may hear a faint clicking sound and feel a mild vibration. Additional treatments, like a stent placement, are typically used afterwards. The entire procedure may take anywhere from 30 minutes to several hours.

4. Post-procedure: Once an IVL procedure is complete, the catheter is removed, and the access site is closed, often with manual pressure or a vessel closure device. Patients are then monitored in a recovery area. They might be discharged the same day or might require a short hospital stay.

IVL is a Relatively Safe Procedure for the Treatment of Calcified Arteries

IVL is generally considered to be a safe procedure for modifying plaque in coronary and peripheral arteries. Peer-reviewed studies have indicated that IVL has a favorable safety profile, with a low incidence of procedure-related complications.(24) In vulnerable patients with intricate coronary issues, the in-hospital and 30-day rates of major adverse cardiac events are low, with fewer than 2% of patients needing artery dissection.(24)

Real World Case Studies Show IVL is a Safe, Effective Treatment for Artery Calcification

Intravascular lithotripsy has proven to be a relatively safe and effective treatment for both peripheral and coronary blockages, as shown in real-world case studies.(24) These studies highlight IVL's prowess in addressing even the most challenging calcified lesions, which leads to enhanced patient outcomes and minimized complications.

Studies Show Successful Peripheral Applications Using IVL

Peripheral applications of IVL have been extensively studied in various clinical trials, including Disrupt PAD I, II, III, and Disrupt BTK. These studies have primarily examined the safety and efficacy of IVL for treating calcified lesions in peripheral arteries.(25,26,27)

A comprehensive meta-analysis of these studies, which included 336 patients across different peripheral vascular territories, revealed that IVL significantly reduced diameter stenosis by 55.1%, with an overall mean final diameter stenosis of 23.7%.(28)

Real world case studies have also shown a positive safety profile for IVL in peripheral applications, with minimal complications. Core laboratory-assessed lesion-level complications occurred in only 1.22% of the treated lesions. These complications comprised flow-limiting dissections and vessel perforation which were attributed to drug-coated balloon inflation, not IVL.(28)

Notably, there were no reported incidents of distal embolization, thrombus, abrupt closure, or no-reflow events. The great news for patients is that research is pointing to IVL being an effective treatment for patients with peripheral artery disease involving calcified lesions.(25,26,27,28)

Studies Show Successful Coronary Applications Using IVL

IVL's role in treating calcification in coronary arteries offers a promising solution for patients with heavily calcified coronary stenoses. In the Disrupt CAD I study involving 60 patients, IVL successfully reduced the average stenosis to 13%, facilitating stent delivery to all target areas, and achieved a 95% clinical success rate with minimal complications.(29) The Disrupt CAD II and III studies further validated the effectiveness of IVL, showing that fewer than 2% of patients experienced serious complications like artery dissection.(24)

Possible Complications of Intravascular Lithotripsy

Studies on intravascular lithotripsy have delved into the challenges posed by coronary artery calcification. Although various techniques like high-pressure, noncompliant balloon dilation, specialty balloons, and atherectomy are employed to combat severe CAD and PAD, they come with limitations. Specifically, atherectomy has higher risks of complications such as slow-flow, periprocedural MI, complex dissection, and perforation than balloon-based therapies.(20,21,24,28)

Acoustic shock waves used by IVL can activate mechano-sensitive ion channels in cardiomyocytes, potentially causing ectopic heartbeats or "shocktopics". There is also a risk of tachyarrhythmias.(30)

IVL Contraindications: IVL Should Not Be Used in These Specific Circumstances

IVL systems, when used with IVL catheters, have contraindications that apply across various applications: 

• Stent delivery: IVL should never be used to deliver stents.

• Vessels in the neck or brain: IVL is not recommended for use in vessels located in the neck or brain.

• Patients with severely calcified lesions: Patients with pronounced calcified lesions should exercise caution when considering IVL treatment.

• Bleeding disorders and anticoagulant medication: People with a history of bleeding disorders or those currently taking anticoagulant medication should be advised against IVL procedures.

• In-stent restenosis and guidewire issues: Patients with in-stent restenosis or issues related to guidewire passage across the lesion should approach IVL treatment with caution. 

These contraindications are essential to ensure the safe and effective use of IVL across a range of medical applications. Anyone considering IVL should consult their healthcare provider.

The Growing Market for Coronary Artery Disease in the U.S. and Globally

IVL and other advancements have responded to a growing prevalence of coronary artery disease in the United States and internationally. CAD accounts for over 600,000 deaths annually, and is the leading cause of mortality in the United States and the third leading cause of mortality globally.(31) The high prevalence and mortality of CAD places an immense burden on the healthcare system. Such high prevalence has spurred the growth of the CAD therapeutics and medical device markets.

Research shows that the global CAD market valuation was worth USD 22,943.21 million in 2022.(32) Predictions suggest that this figure could reach an astounding USD 40,987.32 million by 2030, growing at a compound annual growth rate (CAGR) of 8.86% from 2023 to 2030.(32)  Several factors have contributed to this growth, including technological advancements in diagnostics, increasing adoption of minimally invasive procedures, and the rising global demand for CAD and PAD diagnosis, treatment, and management tools.

In response to this escalating demand, pharmaceutical innovators like Pfizer Inc., Amgen Inc., and AbbVie Inc., and key players in the medical device industry like Medtronic, Boston Scientific, and Abbott have been at the forefront of developing innovative solutions. The U.S., with its robust R&D activities and substantial healthcare spending, holds a significant share of this CAD treatment market. The Asia-Pacific region is expected to witness substantial growth in the coming years, owing to their large patient populations and emerging economic opportunities in arterial disease. 

The Market for Peripheral Artery Disease is Growing

It is estimated that well over 200 million people are affected by PAD globally.(33) PAD is more common with age. It is estimated that over 20% of those over the age 80 are affected by PAD.(33) Though often asymptomatic, this disease represents a significant risk to individuals, mainly as an indicator of systemic atherosclerosis. The intrinsic connection between CAD and PAD necessitates a holistic strategy in combating cardiovascular and arterial diseases.

The worldwide market for PAD reached a valuation of USD 4.45 billion in 2022 and is projected to reach USD 9.15 billion by 2031, with an estimated compound annual growth rate (CAGR) of 8.35% expected from 2023 to 2031.(34) 

Several demographic trends drive the growth of the PAD market, including the aging global population, the rising prevalence of conditions like cancer, and the widespread occurrence of metabolic, respiratory, and cardiovascular disorders.(34) These factors necessitate the use of vascular devices during various medical treatments. This article goes into more detail about the economics of IVL, including market size and costs.

The Leading IVL Companies and Products: Shockwave, FastWave, and Emerging IVL Technology

To date, Shockwave Medical has been the leading developer of IVL technologies. Shockwave’s IVL devices, which the company has designed for both peripheral and coronary interventions, have significantly advanced the treatment of calcified plaque. FastWave Medical, a clinical-stage startup, is developing advanced IVL systems that aren't available for commercial use. This article gives more details about the leading IVL companies and products.

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. Current 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.

Feedback from leading interventional physicians has revealed issues with the deliverability and crossability of existing IVL catheters, especially for coronary applications. Bulky balloons are difficult to navigate through tortuous, diseased anatomy, and current IVL balloons rupture too frequently at a rate of 10-20%. This is a relatively high failure rate considering the significant cost of current 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 hurdles with current IVL systems which can be improved upon in next-generation platforms.

Finally, a major concern and area for improvement with current IVL systems is cost. IVL catheters 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.

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 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 improve patient care and lower costs. 

FastWave is Focused on Improving the Design and Performance of IVL Systems

FastWave is focused on addressing existing gaps in IVL, and that 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 shaft for better pushability. Using a dual layer design for the catheter 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 effective treatment of CAD and 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 balloon sizes, 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 currently available for IVL procedures.

FastWave is also 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.

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.(35)

The future of IVL is bright and this article dives deeper into recent advances in the field. 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.

Understanding the Reimbursement Landscape for IVL Procedures

Reimbursement for intravascular lithotripsy differs depending on the procedure’s application, either peripheral or coronary. Several factors influence these rates, including the procedure's nature, case complexity, and specific payer policies. This article goes into greater detail about coronary and peripheral IVL reimbursement practices and codes.

Coronary IVL reimbursement was initiated in 2021 and has seen major developments in the years since. The Centers for Medicare & Medicaid Services (CMS) have instituted new Medicare Severity Diagnosis Related Group (MS-DRG) codes and payments for coronary IVL procedures conducted in the hospital inpatient environment. In August 2023, Shockwave Medical, announced a pivotal update featuring new CMS codes for coronary IVL procedures and increased payments.(36)

New Coronary IVL-Specific Reimbursement Codes Offer Higher Payments

Newer coronary IVL-specific MS-DRGs offer higher payments compared to other PCI procedural reimbursements. The corresponding codes and estimated payments include: 

• MS-DRG 323: Coronary IVL with an intraluminal device, with major complications and comorbidities (MCC); projected payment: $28,987.(36)

• MS-DRG 324: Coronary IVL with an intraluminal device, without MCC; projected payment: $20,785.(36)

• MS-DRG 325: Coronary IVL without an intraluminal device, without CC/MCC; projected payment: $18,514.(36)

Understanding the Reimbursement Landscape for Peripheral IVL Procedures

CMS began providing reimbursement for IVL procedures in peripheral arteries starting at the beginning of 2020. Peripheral IVL reimbursement has evolved considerably in recent years, with coverage in outpatient settings, inpatient environments, and Ambulatory Surgical Centers (ASC). As of 2023, Medicare has introduced payment enhancements for IVL treatments targeting iliac, femoral, and popliteal arteries in the ASC context. 

IVL FAQs: Frequently Asked Questions About Intravascular Lithotripsy

Below are answers to some of the most common questions about intravascular lithotripsy. You can also look up terms related to intravascular lithotripsy on this IVL glossary page.

What is Intravascular Lithotripsy?

Intravascular lithotripsy, or IVL, is an innovative treatment that uses sonic pressure waves, or shock waves, to break up calcified plaque deposits in the arteries. This makes IVL a critical tool for treating coronary and peripheral artery disease. 

How Does IVL Work?

Intravascular lithotripsy is a catheter-based treatment that uses sonic pressure waves, or shock waves, to fragment calcified plaque within arteries. Modifying hard, calcified plaque may improve blood flow for people with arterial diseases like CAD and PAD. Fracturing arterial plaque with IVL may also improve the environment for stent placement and angioplasty.

When is IVL Used and What Conditions is IVL Indicated to Treat?

Today, intravascular lithotripsy is approved for modifying calcified plaque within the coronary and peripheral arteries. This makes IVL a leading option for the treatment of calcium deposits associated with CAD and PAD.

What is the Purpose of an IVL Procedure?

The purpose of an IVL procedure is to modify the hard, calcified plaque in a person’s arteries in order to optimize stent placement and improve blood flow. IVL is a critical tool for treating artery calcification in people with CAD and PAD.

Where Did IVL Come From?

IVL technology has its origins in a novel treatment for renal calculi, or kidney stones. This was the first use case for mounting multiple lithotripsy emitters on a traditional catheter platform to deliver shock waves at a targeted lesion. Today this principle is used to treat calcified plaque in arteries.

How Effective is IVL at Treating Calcified Arteries?

Intravascular lithotripsy has proven to be a relatively safe and effective treatment for both peripheral and coronary blockages, as shown in real-world case studies. These studies highlight IVL's prowess in addressing even the most challenging calcified lesions, which leads to enhanced patient outcomes and minimized complications.

You can see a longer list of IVL FAQs on this page.