Expanding Cardiovascular Care Options
Our unique IVL Technology has the potential to change the standard of care for advanced cardiovascular disease by directly addressing a common obstacle in traditional treatment: calcified plaque.
Calcified plaque presents a challenge current technologies are not well-designed to address, resulting in suboptimal outcomes. Localized Lithotripsy Technology facilitates low-pressure lithotripsy-enabled angioplasty — a therapy which can disrupt and restructure even deep, calcified lesions, improving tissue flexibility and opening the door to new treatment options.
Traditional Devices & Techniques
Angioplasty balloons are the device of choice to dilate all types of vascular lesions. While effective in soft lesions, these same balloons must be inflated to extremely high pressures (up to and often in excess of 20 ATM) in an attempt to dilate calcified lesions. Unfortunately, the physics of constant high pressures in the presence of calcium preferentially targets, or damages, soft tissue leading to ineffective dilation in addition to sub-optimal acute and longer term results.
Over the last 20 years, several technologies have been developed in attempts to overcome the shortcomings of high constant pressure, some incremental (scoring and cutting balloons), and some more dramatic and severe (atherectomy). All of these fail to address the fundamental need: effective dilation of calcified lesions while limiting vascular injury and complications such as perforations, distal emboli, and the need for bailout stenting.
Comparison of Traditional Devices Used to Treat Calcified Plaque2
- Uses high constant pressure in an attempt to overcome the resistance of calcified plaque but instead preferentially targets soft tissue.
- High constant pressure leads to excessive force transfer to soft tissue resulting in elastic recoil, frequent dissections, high rates of restenosis and frequently requires stent placement for efficacy or bailout reasons.
Scoring or Cutting Balloon Catheters
- Use high constant pressure and metal elements to cut into soft tissue.
- Limited effectiveness on calcified lesions and can be difficult to deliver to target tissue.
- Excessive and focal force transfer to soft tissue leads to significant soft tissue damage and frequently requires stent placement for efficacy or bailout reasons.
- Extracts atherosclerotic plaque through sanding or shaving of vessel tissue.
- Can be acutely effective in superficial calcium, but neglects the deep calcium that impacts vessel expansion.
- Extensive soft tissue removal creates significant vessel injury and increases the risk of vessel perforation and distal embolization.1,2
- Difficult to use, interrupts procedure flow. Complicated and lengthy procedures require specialized training and a change to normal procedure flow.
How Intravascular Lithotripsy (IVL) Technology Works
Localized Lithotripsy Technology is grounded in the same fundamental principles as traditional lithotripsy, a trusted technology used to break up kidney stones—disruption of calcified tissue using pulsatile mechanical energy designed to minimize soft tissue injury. It utilizes semi-compliant balloon catheters with multiple lithotripsy emitters along the length of the balloon that create diffusive pulsatile mechanical energy to disrupt calcified lesions.1
Lithotripsy emitters are activated while the balloon is inflated at low, sub-nominal pressures. The intermittent pulsatile pressure waves produced are inherently tissue-selective, passing through balloon walls and soft vessel tissue, preferentially interacting with calcified plaque. When the waves come in contact with calcium they create a series of micro-fractures in the plaque, disrupting it, after which the vessel can be effectively dilated using low pressures.
The technology is inherently familiar, easy to use, operates with just the push of a button, and works seamlessly with existing cardiovascular treatments. And because it is built on a traditional balloon catheter platform, it is compatible with clinicians’ existing workflow.
- Levin S. “Shockwave Medical: Cracking the Calcium Code in Cardiology.” The MedTech Strategist, 2015 Aug 12; 12(2):30-37.
- Stuart M. “After Atherectomy: Shockwave Medical Preps For Success.” InterventIonal CardIology, 2014 Feb; 1-4.