The FDA cleared Shockwave Medical’s lithoplasty system Sept. 16 to treat calcified plaque in patients with peripheral artery disease.
The system combines a angioplasty balloon catheter device and sound waves known as lithotripsy, which Shockwave Medical said was typically used to treat patients with kidney stones.
The clearance was based on results of a single-arm, two-phase, multicenter study that found patients who received the lithoplasty system had significant and immediate increases in blood flow in treated vessels and minimal vessel injury. The company also said the system was safe and effective in all patient subgroups. It will present updated results of the trial Sept. 19 at the Vascular Interventional Advances conference in Las Vegas.
Shockwave Medical expects a limited commercial release of the system in the U.S. next year and plans on initiating a randomized clinical trial to gather data on its safety and effectiveness.
In May 2015, Shockwave announced that it had received $40 million in funding, which would be used to develop the lithoplasty system in peripheral, coronary and aortic valve applications.