Shockwave Medical has secured clearance from the US Food and Drug Administration (FDA) for the Lithoplasty System intended for the treatment of calcified plaque in patients with peripheral artery disease (PAD).
PAD impacts nearly nine million people in the US. It blocks blood flow to the legs and feet, causing significant pain and limited mobility, and can lead to surgery or even amputation in severe cases.
Arterial calcification, due to plaque that hardens over time, is increasingly common as preventive care and disease management have enabled patients to live longer, thereby making vascular disease a chronic condition.
Over 50% of all patients with peripheral vascular disease have moderate or severe calcification in their arteries. However, due to limitations of currently available interventional devices, successful treatment of patients with calcified arteries is increasingly more difficult. The Shockwave Medical Lithoplasty System is intended to overcome these issues.
Shockwave Medical CEO and co-founder Daniel Hawkins said: “This marks an exciting milestone for the company as we prepare to begin our commercial activities in the United States.
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"We view this as an important validation of our technology's potential to address the burdens of vascular calcification, and we are looking forward to working with the clinical community to deeply integrate Lithoplasty into the care pathway to improve outcomes for patients with advanced cardiovascular diseases.”
This system is claimed to be the first-ever device designed to selectively target hardened calcium in patients with cardiovascular disease.
The device integrates two familiar and powerful technologies: the calcium-disrupting power of sound waves with the simplicity of angioplasty balloon catheter devices.
Intermittent lithotripsy pulses disrupt both superficial and deep vascular calcium, while reducing soft tissue injury, and an integrated angioplasty balloon expands blockages at low pressures to restore blood flow.
Image: Shockwave Medical's Lithoplasty System. Photo: courtesy of Business Wire.