The system will selectively target hardened calcium in patients with cardiovascular disease.
It incorporates the calcium-disrupting power of sound waves (lithotripsy) with the angioplasty balloon catheter devices.
Intermittent lithotripsy pulses interrupt both superficial and deep vascular calcium, while minimizing soft tissue injury, and an integrated angioplasty balloon expands blockages at low pressures to restore blood flow.
The approval was based on the data from a single-arm, two-phase and multicenter DISRUPT PAD study, which showed safety and performance of the Lithoplasty system to treat PAD.
The system is also available in the European Union for the treatment of PAD.
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 US.
"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.”
Image: Lithoplasty system will be used to treat calcified plaque in patients with peripheral artery disease. Photo: courtesy of Business Wire.
