Frequently Asked Questions about Intravascular Lithotripsy (IVL)
Medically Reviewed by
Matthew Segar, MD
Frequently Asked Questions about Intravascular Lithotripsy (IVL)
Medically Reviewed by
Matthew Segar, MD
Frequently Asked Questions about Intravascular Lithotripsy (IVL)
Medically Reviewed by
Matthew Segar, MD
Intravascular lithotripsy (IVL) is a groundbreaking treatment for artery calcification associated with coronary artery disease (CAD) and peripheral arterial disease (PAD). In this article, we’ll answer the most commonly asked questions about IVL.
What is Intravascular Lithotripsy (IVL)?
Intravascular lithotripsy (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 arterial disease. You can find everything you need to know about intravascular lithotripsy in this article.
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. This article has more details on the science and technology behind IVL procedures.
What Happens During an IVL Procedure?
During an IVL procedure, a lithotripsy catheter with an integrated angioplasty balloon is inserted into the artery. Emitters within the balloon generate sonic pressure waves, or shock waves, that direct mechanical energy at a targeted lesion (or area of plaque blockage in the arteries). This energy creates cracks and fissures in the hard plaque, while passing harmlessly through soft tissues. After the IVL procedure, medical professionals may continue with additional procedures like a stent placement or angiography.
What Are the Steps of an IVL Procedure?
The treatment procedure for IVL includes the following five steps:
IVL catheter insertion: First, the catheter is inserted into the artery and navigated to the targeted calcified blockage.
Device inflation: Next, the angioplasty balloon is inflated within the diseased artery.
Sound wave emission: Once the intravascular lithotripsy catheter is inflated, the 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.
Device deflation: After targeting the plaque with a series of sound or shock waves, the balloon is deflated and the IVL catheter is removed.
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.
Is IVL Safe?
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.(1) To date, there have been no reports of major dissections (types D-F), perforations, abrupt closures, or instances of slow or no blood flow. In vulnerable patients with intricate coronary issues, the in-hospital and 30-day rates of major adverse cardiac events are low, with under 2% dissection rates.(1) This article has more information about IVL safety and potential risks.
Is IVL Painful?
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.
What’s it Like to Be an IVL Patient?
The IVL patient experience usually includes these four steps:
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.
Mild sedation and local anesthesia: Some IVL patients are given mild sedation to help them relax. However, most patients remain awake during the procedure and can communicate with the medical team. Local anesthesia is applied at the site where the catheter will be inserted.
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.
Post-procedure: Once an IVL procedure is complete and the catheter is removed, patients are monitored in a recovery area. They might be discharged the same day or require a short hospital stay.
When is IVL Used?
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 coronary and peripheral arterial disease. This article has more information about when to use IVL.
How Long Does an IVL Treatment Take?
The entire procedure may take anywhere from 30 minutes to several hours, depending on the complexity of the lesions and whether other interventions are also performed.
How is IVL Different From Traditional Angioplasty or Stenting?
IVL offers the potential for safer, more straightforward treatments for calcified plaque. IVL also offers potentially shorter recovery times for patients and better treatment outcomes with the use of intravascular imaging. By modifying hard, calcified plaque, IVL may also make stent and balloon-based treatments more effective.
What Equipment is Used in an IVL Treatment?
IVL is 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 lithotripsy emitters.
Energy generator: The generator powers the emitters, which generate sonic pressure waves, or shock waves.
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. This article goes into more detail about how plaque builds in the arteries over time and can lead to conditions like CAD and PAD.
Where Did IVL Come From?
IVL technology has its origins in a novel treatment for renal calculi, or kidney stones.(2) 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.
Are There Side Effects or Complications with IVL?
The most common complications associated with IVL are similar to those seen in other catheter-based interventions, such as dissection, perforation, or bleeding at the access site. However, the frequency of these complications in initial IVL studies has been low, with fewer than 2% experiencing artery dissection.(1)
Acoustic shock waves generated by IVL can activate mechano-sensitive ion channels in cardiomyocytes, potentially causing ectopic heartbeats or "shocktopics." There is also a risk of tachyarrhythmias.(3)
As with all medical procedures, there are limitations and uncertainties associated with IVL. The long-term outcomes of IVL, potential rare complications of IVL, and optimal patient selection are all areas of ongoing research. To date, IVL has proven to be a relatively safe procedure involving few complications and minimal patient discomfort.
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.(1,4,5,6,7) These studies highlight IVL's prowess in addressing even the most challenging calcified lesions, which leads to enhanced patient outcomes and minimized complications.(4,5,6,7)
Does IVL Work for Peripheral Arteries and PAD?
Peripheral applications of IVL have been extensively studied in various clinical trials, including Disrupt PAD I, II, III, and Disrupt BTK.(4,5,7) A comprehensive meta-analysis of these studies, which included 336 patients across different peripheral vascular territories, showed strong results. IVL significantly reduced diameter stenosis by 55.1%, with an overall mean final diameter stenosis of 23.7%.(6)
Does IVL Work for Coronary Arteries and CAD?
Real world studies have shown positive coronary results for IVL. In the Disrupt CAD I study involving 60 patients, IVL successfully reduced the average stenosis to 12%, facilitating stent delivery to all target areas, and achieved a 95% clinical success rate with minimal complications.(8) The Disrupt CAD II and III studies further validated the effectiveness of the IVL, showing fewer than 2% of patients experiencing artery dissection.(1)
What is the Future of IVL?
The medical community is hoping to broaden the approved applications of IVL beyond only the coronary and peripheral arteries. IVL is currently under investigation for its potential to address conditions like chronic total occlusions and structural heart applications. To ensure patient safety, IVL should never be used for purposes beyond its specific approved indications.
How is Intravascular Imaging Used in IVL Procedures?
Medical professionals can 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. 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 atherectomy, IVL, or other tools.
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.
When Should You Not Use IVL?
IVL systems, when used with IVL catheters, have contraindications that apply across various applications:
Stent delivery: IVL should never be used to directly 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.
How Can IVL Be Improved?
In the IVL field, some areas still warrant improvement to reach the full potential of the technology for patients. These include the creation of innovative devices to address long, profuse calcium and the need to extend the treatment duration.
One of the ways FastWave Medical is trying to improve IVL catheter performance is by increasing the number of energy pulses available to medical professionals during a treatment. More pulses – which means more mechanical energy being harnessed against plaque – could lead to a more effective modification of the plaque and a more effective treatment of CAD or PAD. FastWave is also working on introducing various rupture-resistant balloons with slimmer profiles that could make it easier to cross calcified plaque.
Check out this article to learn more about the latest advancements in IVL technology.
What are the Top IVL Brands and Products?
To date, Shockwave Medical has been the leading developer of IVL technologies. Building on their pioneering work, FastWave Medical is carving a niche in the IVL space with a differentiated approach that addresses existing gaps in IVL treatment. FastWave Medical technologies are not yet approved for patient use, but the company is planning to offer many IVL improvements. This article looks closer at the leading IVL companies and products.
Is IVL Covered by Insurance?
Yes, both peripheral and coronary IVL procedures may be covered and reimbursed by Medicare or other insurance carriers. This article goes into more detail about the IVL reimbursement landscape.
What is the Reimbursement Landscape for Coronary IVL Procedures?
Coronary IVL reimbursement was initiated in 2021. 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. These codes are an important element of the 2024 Medicare Hospital Inpatient Prospective Payment System (IPPS) final rule, set to be effective from October 1, 2023.(9)
What is 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).
The peripheral IVL reimbursement rates and specifics can be influenced by various factors, including the nature of the procedure and the setting in which it's conducted. For a comprehensive understanding, consult with reimbursement specialists who can provide real-time answers and guidance regarding billing and coding.
What Are Other Treatments for Calcified Arteries Besides IVL?
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, metal scaffolding called a stent can be placed inside a vessel to aid in healing or relieve an obstruction.(10)
To address plaque removal challenges, several innovative new medical technologies have arisen. These include:
Drug-coated balloons (DCB): Medication-coated angioplasty balloons that release their drug upon inflation, reducing scar tissue formation.(11)
Bare metal and drug-eluting stents: Bare metal stents provide immediate support to prevent artery collapse post-angioplasty. Drug-eluting stents are coated with medication and help ensure the artery remains clear.(12)
Plaque modification tools: Atherectomy devices aim to cut or grind away calcium deposits in the arteries. There are also specialty balloons equipped with metallic elements that make precise incisions in calcified plaque, aiding in vessel expansion.
Rotational ablative techniques: A category of devices designed to “ablate” or remove heavily calcified plaque. The device moves rotationally, helping to cross difficult plaque that stents or traditional balloon angioplasty may struggle with.
This article breaks down the treatment landscape for CAD and PAD.
What is the Market Size for CAD and PAD Treatments?
Research shows that the global CAD market valuation was worth USD 22,943.21 million in 2022.(13) This article goes into more detail about the economics and costs of IVL and other CAD and PAD treatments.
More Questions about IVL?
This article contains everything you need to know about intravascular lithotripsy. You can also check out this IVL glossary page that defines many of the scientific and technical terms used in this article.
Intravascular lithotripsy (IVL) is a groundbreaking treatment for artery calcification associated with coronary artery disease (CAD) and peripheral arterial disease (PAD). In this article, we’ll answer the most commonly asked questions about IVL.
What is Intravascular Lithotripsy (IVL)?
Intravascular lithotripsy (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 arterial disease. You can find everything you need to know about intravascular lithotripsy in this article.
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. This article has more details on the science and technology behind IVL procedures.
What Happens During an IVL Procedure?
During an IVL procedure, a lithotripsy catheter with an integrated angioplasty balloon is inserted into the artery. Emitters within the balloon generate sonic pressure waves, or shock waves, that direct mechanical energy at a targeted lesion (or area of plaque blockage in the arteries). This energy creates cracks and fissures in the hard plaque, while passing harmlessly through soft tissues. After the IVL procedure, medical professionals may continue with additional procedures like a stent placement or angiography.
What Are the Steps of an IVL Procedure?
The treatment procedure for IVL includes the following five steps:
IVL catheter insertion: First, the catheter is inserted into the artery and navigated to the targeted calcified blockage.
Device inflation: Next, the angioplasty balloon is inflated within the diseased artery.
Sound wave emission: Once the intravascular lithotripsy catheter is inflated, the 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.
Device deflation: After targeting the plaque with a series of sound or shock waves, the balloon is deflated and the IVL catheter is removed.
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.
Is IVL Safe?
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.(1) To date, there have been no reports of major dissections (types D-F), perforations, abrupt closures, or instances of slow or no blood flow. In vulnerable patients with intricate coronary issues, the in-hospital and 30-day rates of major adverse cardiac events are low, with under 2% dissection rates.(1) This article has more information about IVL safety and potential risks.
Is IVL Painful?
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.
What’s it Like to Be an IVL Patient?
The IVL patient experience usually includes these four steps:
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.
Mild sedation and local anesthesia: Some IVL patients are given mild sedation to help them relax. However, most patients remain awake during the procedure and can communicate with the medical team. Local anesthesia is applied at the site where the catheter will be inserted.
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.
Post-procedure: Once an IVL procedure is complete and the catheter is removed, patients are monitored in a recovery area. They might be discharged the same day or require a short hospital stay.
When is IVL Used?
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 coronary and peripheral arterial disease. This article has more information about when to use IVL.
How Long Does an IVL Treatment Take?
The entire procedure may take anywhere from 30 minutes to several hours, depending on the complexity of the lesions and whether other interventions are also performed.
How is IVL Different From Traditional Angioplasty or Stenting?
IVL offers the potential for safer, more straightforward treatments for calcified plaque. IVL also offers potentially shorter recovery times for patients and better treatment outcomes with the use of intravascular imaging. By modifying hard, calcified plaque, IVL may also make stent and balloon-based treatments more effective.
What Equipment is Used in an IVL Treatment?
IVL is 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 lithotripsy emitters.
Energy generator: The generator powers the emitters, which generate sonic pressure waves, or shock waves.
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. This article goes into more detail about how plaque builds in the arteries over time and can lead to conditions like CAD and PAD.
Where Did IVL Come From?
IVL technology has its origins in a novel treatment for renal calculi, or kidney stones.(2) 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.
Are There Side Effects or Complications with IVL?
The most common complications associated with IVL are similar to those seen in other catheter-based interventions, such as dissection, perforation, or bleeding at the access site. However, the frequency of these complications in initial IVL studies has been low, with fewer than 2% experiencing artery dissection.(1)
Acoustic shock waves generated by IVL can activate mechano-sensitive ion channels in cardiomyocytes, potentially causing ectopic heartbeats or "shocktopics." There is also a risk of tachyarrhythmias.(3)
As with all medical procedures, there are limitations and uncertainties associated with IVL. The long-term outcomes of IVL, potential rare complications of IVL, and optimal patient selection are all areas of ongoing research. To date, IVL has proven to be a relatively safe procedure involving few complications and minimal patient discomfort.
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.(1,4,5,6,7) These studies highlight IVL's prowess in addressing even the most challenging calcified lesions, which leads to enhanced patient outcomes and minimized complications.(4,5,6,7)
Does IVL Work for Peripheral Arteries and PAD?
Peripheral applications of IVL have been extensively studied in various clinical trials, including Disrupt PAD I, II, III, and Disrupt BTK.(4,5,7) A comprehensive meta-analysis of these studies, which included 336 patients across different peripheral vascular territories, showed strong results. IVL significantly reduced diameter stenosis by 55.1%, with an overall mean final diameter stenosis of 23.7%.(6)
Does IVL Work for Coronary Arteries and CAD?
Real world studies have shown positive coronary results for IVL. In the Disrupt CAD I study involving 60 patients, IVL successfully reduced the average stenosis to 12%, facilitating stent delivery to all target areas, and achieved a 95% clinical success rate with minimal complications.(8) The Disrupt CAD II and III studies further validated the effectiveness of the IVL, showing fewer than 2% of patients experiencing artery dissection.(1)
What is the Future of IVL?
The medical community is hoping to broaden the approved applications of IVL beyond only the coronary and peripheral arteries. IVL is currently under investigation for its potential to address conditions like chronic total occlusions and structural heart applications. To ensure patient safety, IVL should never be used for purposes beyond its specific approved indications.
How is Intravascular Imaging Used in IVL Procedures?
Medical professionals can 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. 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 atherectomy, IVL, or other tools.
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.
When Should You Not Use IVL?
IVL systems, when used with IVL catheters, have contraindications that apply across various applications:
Stent delivery: IVL should never be used to directly 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.
How Can IVL Be Improved?
In the IVL field, some areas still warrant improvement to reach the full potential of the technology for patients. These include the creation of innovative devices to address long, profuse calcium and the need to extend the treatment duration.
One of the ways FastWave Medical is trying to improve IVL catheter performance is by increasing the number of energy pulses available to medical professionals during a treatment. More pulses – which means more mechanical energy being harnessed against plaque – could lead to a more effective modification of the plaque and a more effective treatment of CAD or PAD. FastWave is also working on introducing various rupture-resistant balloons with slimmer profiles that could make it easier to cross calcified plaque.
Check out this article to learn more about the latest advancements in IVL technology.
What are the Top IVL Brands and Products?
To date, Shockwave Medical has been the leading developer of IVL technologies. Building on their pioneering work, FastWave Medical is carving a niche in the IVL space with a differentiated approach that addresses existing gaps in IVL treatment. FastWave Medical technologies are not yet approved for patient use, but the company is planning to offer many IVL improvements. This article looks closer at the leading IVL companies and products.
Is IVL Covered by Insurance?
Yes, both peripheral and coronary IVL procedures may be covered and reimbursed by Medicare or other insurance carriers. This article goes into more detail about the IVL reimbursement landscape.
What is the Reimbursement Landscape for Coronary IVL Procedures?
Coronary IVL reimbursement was initiated in 2021. 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. These codes are an important element of the 2024 Medicare Hospital Inpatient Prospective Payment System (IPPS) final rule, set to be effective from October 1, 2023.(9)
What is 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).
The peripheral IVL reimbursement rates and specifics can be influenced by various factors, including the nature of the procedure and the setting in which it's conducted. For a comprehensive understanding, consult with reimbursement specialists who can provide real-time answers and guidance regarding billing and coding.
What Are Other Treatments for Calcified Arteries Besides IVL?
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, metal scaffolding called a stent can be placed inside a vessel to aid in healing or relieve an obstruction.(10)
To address plaque removal challenges, several innovative new medical technologies have arisen. These include:
Drug-coated balloons (DCB): Medication-coated angioplasty balloons that release their drug upon inflation, reducing scar tissue formation.(11)
Bare metal and drug-eluting stents: Bare metal stents provide immediate support to prevent artery collapse post-angioplasty. Drug-eluting stents are coated with medication and help ensure the artery remains clear.(12)
Plaque modification tools: Atherectomy devices aim to cut or grind away calcium deposits in the arteries. There are also specialty balloons equipped with metallic elements that make precise incisions in calcified plaque, aiding in vessel expansion.
Rotational ablative techniques: A category of devices designed to “ablate” or remove heavily calcified plaque. The device moves rotationally, helping to cross difficult plaque that stents or traditional balloon angioplasty may struggle with.
This article breaks down the treatment landscape for CAD and PAD.
What is the Market Size for CAD and PAD Treatments?
Research shows that the global CAD market valuation was worth USD 22,943.21 million in 2022.(13) This article goes into more detail about the economics and costs of IVL and other CAD and PAD treatments.
More Questions about IVL?
This article contains everything you need to know about intravascular lithotripsy. You can also check out this IVL glossary page that defines many of the scientific and technical terms used in this article.
Intravascular lithotripsy (IVL) is a groundbreaking treatment for artery calcification associated with coronary artery disease (CAD) and peripheral arterial disease (PAD). In this article, we’ll answer the most commonly asked questions about IVL.
What is Intravascular Lithotripsy (IVL)?
Intravascular lithotripsy (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 arterial disease. You can find everything you need to know about intravascular lithotripsy in this article.
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. This article has more details on the science and technology behind IVL procedures.
What Happens During an IVL Procedure?
During an IVL procedure, a lithotripsy catheter with an integrated angioplasty balloon is inserted into the artery. Emitters within the balloon generate sonic pressure waves, or shock waves, that direct mechanical energy at a targeted lesion (or area of plaque blockage in the arteries). This energy creates cracks and fissures in the hard plaque, while passing harmlessly through soft tissues. After the IVL procedure, medical professionals may continue with additional procedures like a stent placement or angiography.
What Are the Steps of an IVL Procedure?
The treatment procedure for IVL includes the following five steps:
IVL catheter insertion: First, the catheter is inserted into the artery and navigated to the targeted calcified blockage.
Device inflation: Next, the angioplasty balloon is inflated within the diseased artery.
Sound wave emission: Once the intravascular lithotripsy catheter is inflated, the 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.
Device deflation: After targeting the plaque with a series of sound or shock waves, the balloon is deflated and the IVL catheter is removed.
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.
Is IVL Safe?
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.(1) To date, there have been no reports of major dissections (types D-F), perforations, abrupt closures, or instances of slow or no blood flow. In vulnerable patients with intricate coronary issues, the in-hospital and 30-day rates of major adverse cardiac events are low, with under 2% dissection rates.(1) This article has more information about IVL safety and potential risks.
Is IVL Painful?
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.
What’s it Like to Be an IVL Patient?
The IVL patient experience usually includes these four steps:
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.
Mild sedation and local anesthesia: Some IVL patients are given mild sedation to help them relax. However, most patients remain awake during the procedure and can communicate with the medical team. Local anesthesia is applied at the site where the catheter will be inserted.
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.
Post-procedure: Once an IVL procedure is complete and the catheter is removed, patients are monitored in a recovery area. They might be discharged the same day or require a short hospital stay.
When is IVL Used?
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 coronary and peripheral arterial disease. This article has more information about when to use IVL.
How Long Does an IVL Treatment Take?
The entire procedure may take anywhere from 30 minutes to several hours, depending on the complexity of the lesions and whether other interventions are also performed.
How is IVL Different From Traditional Angioplasty or Stenting?
IVL offers the potential for safer, more straightforward treatments for calcified plaque. IVL also offers potentially shorter recovery times for patients and better treatment outcomes with the use of intravascular imaging. By modifying hard, calcified plaque, IVL may also make stent and balloon-based treatments more effective.
What Equipment is Used in an IVL Treatment?
IVL is 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 lithotripsy emitters.
Energy generator: The generator powers the emitters, which generate sonic pressure waves, or shock waves.
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. This article goes into more detail about how plaque builds in the arteries over time and can lead to conditions like CAD and PAD.
Where Did IVL Come From?
IVL technology has its origins in a novel treatment for renal calculi, or kidney stones.(2) 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.
Are There Side Effects or Complications with IVL?
The most common complications associated with IVL are similar to those seen in other catheter-based interventions, such as dissection, perforation, or bleeding at the access site. However, the frequency of these complications in initial IVL studies has been low, with fewer than 2% experiencing artery dissection.(1)
Acoustic shock waves generated by IVL can activate mechano-sensitive ion channels in cardiomyocytes, potentially causing ectopic heartbeats or "shocktopics." There is also a risk of tachyarrhythmias.(3)
As with all medical procedures, there are limitations and uncertainties associated with IVL. The long-term outcomes of IVL, potential rare complications of IVL, and optimal patient selection are all areas of ongoing research. To date, IVL has proven to be a relatively safe procedure involving few complications and minimal patient discomfort.
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.(1,4,5,6,7) These studies highlight IVL's prowess in addressing even the most challenging calcified lesions, which leads to enhanced patient outcomes and minimized complications.(4,5,6,7)
Does IVL Work for Peripheral Arteries and PAD?
Peripheral applications of IVL have been extensively studied in various clinical trials, including Disrupt PAD I, II, III, and Disrupt BTK.(4,5,7) A comprehensive meta-analysis of these studies, which included 336 patients across different peripheral vascular territories, showed strong results. IVL significantly reduced diameter stenosis by 55.1%, with an overall mean final diameter stenosis of 23.7%.(6)
Does IVL Work for Coronary Arteries and CAD?
Real world studies have shown positive coronary results for IVL. In the Disrupt CAD I study involving 60 patients, IVL successfully reduced the average stenosis to 12%, facilitating stent delivery to all target areas, and achieved a 95% clinical success rate with minimal complications.(8) The Disrupt CAD II and III studies further validated the effectiveness of the IVL, showing fewer than 2% of patients experiencing artery dissection.(1)
What is the Future of IVL?
The medical community is hoping to broaden the approved applications of IVL beyond only the coronary and peripheral arteries. IVL is currently under investigation for its potential to address conditions like chronic total occlusions and structural heart applications. To ensure patient safety, IVL should never be used for purposes beyond its specific approved indications.
How is Intravascular Imaging Used in IVL Procedures?
Medical professionals can 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. 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 atherectomy, IVL, or other tools.
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.
When Should You Not Use IVL?
IVL systems, when used with IVL catheters, have contraindications that apply across various applications:
Stent delivery: IVL should never be used to directly 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.
How Can IVL Be Improved?
In the IVL field, some areas still warrant improvement to reach the full potential of the technology for patients. These include the creation of innovative devices to address long, profuse calcium and the need to extend the treatment duration.
One of the ways FastWave Medical is trying to improve IVL catheter performance is by increasing the number of energy pulses available to medical professionals during a treatment. More pulses – which means more mechanical energy being harnessed against plaque – could lead to a more effective modification of the plaque and a more effective treatment of CAD or PAD. FastWave is also working on introducing various rupture-resistant balloons with slimmer profiles that could make it easier to cross calcified plaque.
Check out this article to learn more about the latest advancements in IVL technology.
What are the Top IVL Brands and Products?
To date, Shockwave Medical has been the leading developer of IVL technologies. Building on their pioneering work, FastWave Medical is carving a niche in the IVL space with a differentiated approach that addresses existing gaps in IVL treatment. FastWave Medical technologies are not yet approved for patient use, but the company is planning to offer many IVL improvements. This article looks closer at the leading IVL companies and products.
Is IVL Covered by Insurance?
Yes, both peripheral and coronary IVL procedures may be covered and reimbursed by Medicare or other insurance carriers. This article goes into more detail about the IVL reimbursement landscape.
What is the Reimbursement Landscape for Coronary IVL Procedures?
Coronary IVL reimbursement was initiated in 2021. 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. These codes are an important element of the 2024 Medicare Hospital Inpatient Prospective Payment System (IPPS) final rule, set to be effective from October 1, 2023.(9)
What is 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).
The peripheral IVL reimbursement rates and specifics can be influenced by various factors, including the nature of the procedure and the setting in which it's conducted. For a comprehensive understanding, consult with reimbursement specialists who can provide real-time answers and guidance regarding billing and coding.
What Are Other Treatments for Calcified Arteries Besides IVL?
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, metal scaffolding called a stent can be placed inside a vessel to aid in healing or relieve an obstruction.(10)
To address plaque removal challenges, several innovative new medical technologies have arisen. These include:
Drug-coated balloons (DCB): Medication-coated angioplasty balloons that release their drug upon inflation, reducing scar tissue formation.(11)
Bare metal and drug-eluting stents: Bare metal stents provide immediate support to prevent artery collapse post-angioplasty. Drug-eluting stents are coated with medication and help ensure the artery remains clear.(12)
Plaque modification tools: Atherectomy devices aim to cut or grind away calcium deposits in the arteries. There are also specialty balloons equipped with metallic elements that make precise incisions in calcified plaque, aiding in vessel expansion.
Rotational ablative techniques: A category of devices designed to “ablate” or remove heavily calcified plaque. The device moves rotationally, helping to cross difficult plaque that stents or traditional balloon angioplasty may struggle with.
This article breaks down the treatment landscape for CAD and PAD.
What is the Market Size for CAD and PAD Treatments?
Research shows that the global CAD market valuation was worth USD 22,943.21 million in 2022.(13) This article goes into more detail about the economics and costs of IVL and other CAD and PAD treatments.
More Questions about IVL?
This article contains everything you need to know about intravascular lithotripsy. You can also check out this IVL glossary page that defines many of the scientific and technical terms used in this article.
Sources and References
See How You Can Invest in FastWave
We oversubscribed our last round of financing in just a few weeks, so don’t miss out on the next opportunity to invest.
IVL is an impressive therapy with an attractive market and I’m very excited about FastWave’s prospects.
Dr. Puneet Khanna
Interventional Cardiologist & Medtech Investor
See How You Can Invest in FastWave
We oversubscribed our last round of financing in just a few weeks, so don’t miss out on the next opportunity to invest.
IVL is an impressive therapy with an attractive market and I’m very excited about FastWave’s prospects.
Dr. Puneet Khanna
Interventional Cardiologist & Medtech Investor
See How You Can Invest in FastWave
We oversubscribed our last round of financing in just a few weeks, so don’t miss out on the next opportunity to invest.
IVL is an impressive therapy with an attractive market and I’m very excited about FastWave’s prospects.
Dr. Puneet Khanna
Interventional Cardiologist & Medtech Investor
