Shockwave Medical said today that it won 510(k) clearance from the FDA for its Lithoplasty system, which is designed to treat calcified plaque in patients with peripheral artery disease.
The Fremont, Calif.-based company’s Lithoplasty device uses intermittent lithotripsy pulses to disrupt superficial and deep vascular calcium and an angioplasty balloon to expand blockages at low pressures to restore blood flow.
“This marks an exciting milestone for the company as we prepare to begin our commercial activities in the United States. We view this as an important validation of our technology’s potential to address the burdens of vascular calcification, and we are looking forward to working with the clinical community to deeply integrate Lithoplasty into the care pathway to improve outcomes for patients with advanced cardiovascular diseases,” co-founder & CEO Daniel Hawkins said in a press release.
The clearance was based on data from Shockwave Medical’s Disrupt PAD study, which reported the device as safe and efficient with increases in blood flow and treated vessels and minimal vessel injury.
“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. 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,” Dr. Kenneth Rosenfield, of Mass. General Hospital, said in prepared remarks.
The company said it’s planning a limited U.S. release and a global trial of the system in 2017.
“We are thrilled to reach this important milestone and we look forward to partnering with physicians to help advance the treatment of peripheral artery disease,” co-founder Dr. Todd Brinton said in a prepared statement.
Last May Shockwave raised a $40 million funding round for Lithoplasty. Investors included prior backer Sofinnova Partners and newcomer Venrock, as well as RA Capital, Deerfield, Sectoral Asset Management, Ally Bridge group and 2 undisclosed large-cap investors.