Peripheral Artery Disease and Calcium
As patients with PAD live longer thanks to improved therapeutic options and lifestyle changes, the plaque in their arteries mineralizes and becomes calcified. Over the last few decades, the prevalence of calcified lesions has risen along with life expectancy, with severe calcium being present in as many as 60% of patients with PAD.3 The incremental nature of improvements to devices available to treat these lesions has resulted in calcium becoming a significant obstacle to achieving successful outcomes.
The most common device used to treat calcified lesions is a standard balloon dilatation catheter, often deployed at very high constant pressure. Unfortunately, the physics of constant high pressures in the presence of calcium preferentially targets, or damages, soft tissue leading to elastic recoil, dissections and frequently requires a bailout stent. This has been known to occur in up to 60% of standard lesions, and may occur even more often in calcified lesions.4
Over the last 20 years several technologies have been developed in an attempt to overcome these shortcomings, some incremental such as scoring and cutting balloons, and others more dramatic and severe such as atherectomy. Each of these fails 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.
Intravascular Lithotripsy (IVL) Technology Solution for PAD
Shockwave Medical leveraged the power of IVL Technology to develop devices for the treatment of calcified peripheral vascular lesions. Built on a semi-compliant balloon platform, each catheter incorporates multiple lithotripsy emitters activated (with the touch of a button) while the integrated balloon is inflated to low sub-nominal pressures. Once activated, these emitters produce pulsatile mechanical waves that are inherently tissue-selective, passing through the balloon and soft vascular tissue, preferentially disrupting the calcified plaque by creating a series of micro-fractures. Once the calcium has been disrupted, the vessel can be effectively dilated using low pressures thereby enabling even historically challenging PAD patients to be treated effectively and with minimal injury to the vessel.5
In an initial peripheral clinical study of 99% moderate and severely calcified lesions, Intravascular Lithotripsy (IVL) Technology demonstrated ease of use, minimal interruption to procedure flow and an excellent safety profile. Treatment with IVL Technology resulted in a low residual stenosis of 24% and with only 1 stent implanted. Click here for more information.
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.
Peripheral Intravascular Lithotripsy (IVL) Balloon Dilatation catheters are available in diameters ranging from 3.5mm to 7.0mm. Standard balloon techniques, integrated proximal and distal markers and predetermined IVL Technology settings ensure the catheters can be prepared, delivered, accurately placed and activated with minimal disruption to standard procedure flow.
Miniaturized lithotripsy emitters apply intermittent pulsatile pressure waves along the length and diameter of the balloon. Activated under low pressure (4 atmospheres), these pressure waves selectively disrupt calcified lesions, after which the balloon can be dilated to reference vessel diameter.
|DIAMETER (mm)||LENGTH (mm)||GUIDEWIRE COMPATIBILITY (in)||SHEATH COMPATIBILITY||WORKING LENGTH (cm)|
Summary of Treatment Options for PAD and Calcium
|TREATMENT||DESCRIPTION||Impact on Calcium|
|Intravascular Lithotripsy (IVL) Catheters||
- Centers for Disease Control and Prevention. Peripheral Arterial Disease in the legs, http://www.cdc.gov/DHDSP/data_statistics/fact_sheets/fs_PAD.htm.
- Rocha-Sinh KJ1, Jaff MR, Crabtree TR, Bloch DA, Ansel G; Viva Physicians, Inc. “Performance goals and endpoint assessments for clinical trials of femoropopliteal bare nitinol stents in patients with symptomatic peripheral arterial disease.” Catheter Cardiovasc Interv. 2007. May 1;69(6):910-9.
- F.Fanelli et al.: Calcium Assessment and Impact on DEB. Cardiovasc Intervent Radiol (2014) 37:898-907
- Tepe et al.; Drug-coated Balloons and SFA Lesions, Circulation 2015;131:495-502
- Levin S. “Shockwave Medical: Cracking the Calcium Code in Cardiology.” The MedTech Strategist, 2015 Aug 12; 12(2):30-37.