Intravascular lithotripsy (IVL) has emerged as a groundbreaking treatment for calcified arteries. Today, IVL is approved specifically for modifying calcified plaque within the coronary and peripheral arteries. In this article, we’ll explain when IVL is used. We’ll also discuss when not to use IVL, and consider potential future uses for IVL.

IVL is Approved for Treating Plaque Within the Coronary and Peripheral Arteries

Today, intravascular lithotripsy is specifically approved for modifying calcified plaque within the coronary and peripheral arteries. IVL technology has been FDA-cleared for the treatment of peripheral arteries in the United States since 2016. IVL has been FDA-cleared for treatment of coronary arteries since 2021. It’s a groundbreaking option for the treatment of calcium deposits associated with coronary artery disease (CAD) and peripheral arterial disease (PAD), which together affect over 5% of the adult population.(1) This article gives a background on how calcified plaque can accumulate in arteries and lead to CAD and PAD.

IVL Technology Offers Numerous Benefits Compared with Traditional Treatments

Intravascular lithotripsy is an innovative approach to treating calcified lesions in the coronary and peripheral arteries. 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. IVL potentially sidesteps the steep learning curve and the intricate setup linked with rotational/orbital atherectomy devices, reducing risks like coronary perforation or no-reflow for the patient, and making setup and administration less complicated for medical professionals.

IVL technology is centered around the use of sonic pressure waves, or shock waves, to direct mechanical energy at a target 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. Traditional treatments like angioplasty may be less effective than IVL against the most difficult lesions. As arterial plaque becomes calcified, it poses distinct challenges to drug delivery and may compromise stent expansion. IVL has become a leading tool for modifying these hard, calcified plaques in the coronary and peripheral arteries.  This article gives a step-by-step breakdown of an IVL procedure in peripheral or coronary arteries.

Real World Case Studies Show IVL is a Safe, Effective Treatment for Calcified Lesions

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.(2) These studies highlight IVL's prowess in addressing even the most challenging calcified lesions, which leads to enhanced patient outcomes and minimized complications.(2)

Clinical 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.(2,3,4,5) These studies have primarily examined the safety and efficacy of IVL for treating calcified lesions in peripheral arteries.

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%.(6)

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.(6)

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.(3,4,5,6) You can learn more about IVL’s safety profile here.

Clinical 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 12%, facilitating stent delivery to all target areas, and achieved a 95% clinical success rate with minimal complications.(7) The Disrupt CAD II and III studies further validated the effectiveness of IVL, with under 2% of patients needing artery dissection.(2)

Case Studies Show Diverse Vascular Applications for IVL

Intravascular lithotripsy (IVL) may also aid in facilitating the insertion of large-bore delivery sheaths essential for transcatheter aortic valve replacement.

Studies have further highlighted the efficacy of IVL in facilitating transfemoral access during endovascular aneurysm repair and the placement of mechanical circulatory support devices.(8) These successes point to IVL's versatility and growing importance in managing patients with intricate calcified challenges in various vascular settings.

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. IVL is currently under investigation for its potential to address conditions like chronic total occlusions, structural heart applications, and lesions in the carotid arteries. New research is even showing that IVL has the potential to aid in transvenous lead removal.(9)

Advancements in IVL could also become instrumental in conjunction with other procedures. These include IVL’s potential to complement techniques such as endovascular aneurysm repair, thoracic endovascular aortic repair, and transcatheter aortic valve replacement. The future of IVL is bright – this article dives deeper into recent advances in the IVL 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.

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 for the purposes of delivering 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.

Interested in learning more about IVL technology? This article has everything you need to know about IVL, including potential risks and complications, a background on IVL science, and a breakdown of what it’s like to be an IVL patient.