News | Peripheral Artery Disease (PAD) | June 26, 2017

Shockwave Medical Announces U.S. Commercial Availability of Lithoplasty System

Company also announced enrollment of first patient in DISRUPT PAD III global clinical trial

Shockwave Medical Announces U.S. Commercial Availability of Lithoplasty System

June 26, 2017 — Shockwave Medical recently announced two milestones for its Lithoplasty System for the treatment of calcified plaque in patients with peripheral artery disease (PAD). The first patient was enrolled in the global DISRUPT PAD III clinical trial at the Medical University of Graz, Austria, and the first patient was treated in a commercial case in the United States, at Pottstown Memorial Medical Center in Pottstown, Pa.

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 United States and Europe for the treatment of calcified plaque in peripheral arteries.

Watch the VIDEO "Breaking Up Calcified Lesions Without Vessel Trauma."

DISRUPT PAD III is the largest ever multi-center randomized trial to exclusively enroll 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 percent 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 enroll 334 patients in up to 45 global sites.

Marianne Brodmann, M.D., of the Medical University of Graz, Austria, enrolled the first patient in the trial.

“I’m pleased to be taking part in this important study of the Lithoplasty System for the treatment of complex peripheral artery disease,” said Brodmann. “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.”

Edward Pavillard, D.O., a vascular surgeon with Pottstown Memorial Medical Center, used the Lithoplasty System to treat a patient with PAD in the first commercial U.S. case.

“Peripheral artery disease is a common, painful and possibly limb-threatening disease that can be challenging to treat,” Pavillard said. “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.”

Watch the VIDEO How a Lithoplasty Balloon Shatters Calcified Plaque in Arteries With Ultrasound

Read the article FDA Clears Lithoplasty Balloon That Shatters Calcified Lesions With Ultrasound

Read the article First U.S. Patient Treated in DISRUPT PAD III Study of Lithoplasty Technology

 

For more information: www.shockwavemedical.com

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Angiography shows a stenotic lesion in the mid right coronary artery, undilatable by standard high-pressure balloon angioplasty (inset, arrowheads). (B) Optical coherence tomography (OCT) cross-sectional (top) and longitudinal (bottom) images acquired before IVL and coregistered to the OCT lens (arrow in A) demonstrate severe near-circumferential calcification in the area of the stenosis. (C) Angiography demonstrates improvement in the area of stenosis after IVL lithoplasty.

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