Key Milestones Announced for Shockwave Medical's Lithoplasty System in Treatment of PAD
June 21, 2017—Shockwave Medical, Inc. announced two milestones for its Lithoplasty system for the treatment of calcified plaque in patients with peripheral artery disease (PAD). The Lithoplasty system is designed to treat calcified artery blockages in the leg with lithotripsy, sonic pressure waves historically used to treat patients with kidney stones.
In the United States, Edward Pavillard, DO, performed the treatment in the first patient in a commercial case at Pottstown Memorial Medical Center in Pottstown, Pennsylvania.
In Europe, Marianne Brodmann, MD, enrolled the first patient in the global DISRUPT PAD III clinical trial at the Medical University of Graz in Austria.
The multicenter DISRUPT PAD III postmarket randomized trial is exclusively enrolling patients with heavily calcified PAD. The trial's objective is to assess the optimal therapy to dilate heavily calcified lesions by comparing Shockwave's Lithoplasty system versus traditional angioplasty. The primary goal is achieving > 30% residual stenosis without the need for stenting. All patients who do not receive a stent will be treated with a drug-coated balloon. The trial will enroll 334 patients in up to 45 global sites.
In the company's announcement, Dr. Brodmann commented, “I’m pleased to be taking part in this important study of the Lithoplasty system for the treatment of complex peripheral artery disease. Patients with challenging heavily calcified PAD have been excluded from previous drug-coated balloon trials. The results of the DISRUPT PAD III randomized trial will bear important implications for treatment of this very important patient population.”
Also in Shockwave's press release, Dr. Pavillard stated, “PAD is a common, painful, and possibly limb-threatening disease that can be challenging to treat. Calcified plaque has long been an Achilles heel for many endovascular interventions. The Lithoplasty system 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 United States 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.”
The Lithoplasty technology is now commercially available in both the United States and Europe for the treatment of calcified plaque in peripheral arteries.