Shockwave Medical has announced two milestones for its Lithoplasty system for the treatment of calcified plaque in patients with peripheral artery disease (PAD): enrolment of the first patient in the global DISRUPT PAD III clinical trial at the Medical University of Graz, Austria, and the treatment of the first patient in a commercial case in the USA, at Pottstown Memorial Medical Center in Pottstown.
The Lithoplasty system is designed to treat calcified leg artery blockages with lithotripsy, sonic pressure waves historically used to treat patients with kidney stones. The technology is now commercially available in both the USA and Europe for the treatment of calcified plaque in peripheral arteries.
DISRUPT PAD III is the largest ever multicentre randomised trial to exclusively enrol patients with heavily calcified PAD. The objective of the post-market trial is to assess the optimal therapy to dilate heavily calcified lesions by comparing the Shockwave Medical Lithoplasty system versus traditional angioplasty, with a primary goal of achieving less than 30% residual stenosis without the need for stenting. In addition, all patients who do not receive a stent will be treated with a drug-coated balloon. The trial will enrol 334 patients in up to 45 global sites.
Marianne Brodmann, of the Medical University of Graz, Austria, enrolled the first patient in the trial.
“I am pleased to be taking part in this important study of the Lithoplasty system for the treatment of complex peripheral artery disease,” says Brodmann. “Patients with challenging heavily calcified PAD have been excluded from previous drug coated balloon trials. The results of the DISRUPT PAD III randomised trial will bear important implications for treatment of this very important patient population.”
Edward Pavillard, a vascular surgeon with Pottstown Memorial Medical Center, used the Lithoplasty system to treat a patient with PAD in the first commercial US case.
“Peripheral artery disease is a common, painful and possibly limb threatening disease that can be challenging to treat,” Pavillard says. “Calcified plaque has long been an Achilles heel for many endovascular interventions. The Lithoplasty ystem is a significant advancement in the treatment of PAD, as it provides a new treatment option with potentially less risk of damage or injury to the vessel. I am excited to be among the first in the USA to use this technology to help restore blood flow and improve the quality of life for my patients with complex, traditionally difficult to treat peripheral lesions.”