Lithoplasty Clinical Trial Demonstrates Positive Six-Month Results
Shockwave Medical’s Lithoplasty balloon catheter clinical trial has demonstrated positive six-month results in treating peripheral artery disease, the Fremont, Calif., devicemaker said Monday.
The single-arm multicenter Disrupt PAD study showed that Lithoplasty safely and effectively dilates calcified stenosis with no acute failures, favorable residual stenosis, no major adverse events and no need for stent placement, the company says.
Freedom from reintervention was 100 percent at six months, the devicemaker says. Primary efficacy results also reached 100 percent, characterized as the ability to achieve less than 50 percent residual stenosis using Lithoplasty with or without adjunctive angioplasty.
By prefracturing calcium deposits with lithotripsy techniques, the system can dilate the lesions at a much lower pressure than alternative devices. This greatly reduces vessel injury and saves soft tissue from tearing, a company spokesperson tells Device Daily.
Also, unlike other devices, the system was developed to treat all types of calcified deposits, including deep ones which hinder vessel expansion, the company says.
Shockwave Medical plans a European trial of the device for coronary artery disease later this year. The system received the CE mark this January. — Jason ScottMedical Devices Research and Development