FDA Approves Shockwave Medical's Lithoplasty System to Treat Calcified PAD

September 16, 2016—Shockwave Medical announced that the US Food and Drug Administration (FDA) has cleared the company’s Lithoplasty system for the treatment of calcified plaque in patients with peripheral artery disease (PAD). Shockwave Medical plans a limited commercial release of the Lithoplasty system in the United States in 2017 and will initiate a global randomized trial to gather further clinical data on the benefits of treatment with the device. In 2015, the company announced CE Mark approval for the Lithoplasty system, which is commercially available in Europe.

The Shockwave Medical Lithoplasty system is designed to selectively target hardened calcium in patients with cardiovascular disease. The device integrates intermittent lithotripsy pulses, which disrupt both superficial and deep vascular calcium while minimizing soft tissue injury, and an integrated angioplasty balloon catheter that expands blockages at low pressures to restore blood flow.

Additionally, the company advised that the latest clinical results from the DISRUPT PAD study of the Lithoplasty system will be presented on September 19 at VIVA 2016, the Vascular InterVentional Advances (VIVA) conference held September 18–22 in Las Vegas, Nevada. FDA clearance was supported by positive data from the DISRUPT PAD study.

The DISRUPT PAD study is a single-arm, two-phase, multicenter study evaluating the safety and performance of the Lithoplasty system to treat PAD. The clinical data from DISRUPT PAD demonstrated compelling safety, consistent procedural success across all patient subgroups, significant and immediate increases in blood flow in treated vessels, and minimal vessel injury, reported Shockwave Medical.

In the company’s press release, Kenneth Rosenfield, MD, commented, “Lithoplasty represents a new mechanism of treatment and is revolutionary for the care of patients with calcified peripheral vascular disease, a difficult-to-treat patient population. Existing devices for treating these patients have significant shortcomings that make it challenging to successfully open arteries, while minimizing vascular injury and complications."

Dr. Rosenfield, who is Section Head for Vascular Medicine and Intervention at Massachusetts General Hospital in Boston, Massachusetts, continued, “Lithoplasty is a unique approach that allows us to successfully treat these diseased vessels using a device built on a familiar balloon catheter platform, while minimizing the risk of vessel injury, including dissections that require stenting or other additional interventions."