FDA clears Shockwave’s sound wave balloon for peripheral artery disease

The FDA cleared Shockwave Medical’s angioplasty balloon that delivers ultrasound shockwaves to break up calcified plaques in patients with peripheral artery disease, the company announced Friday. It is the first device that targets hardened calcium in cardiovascular disease patients.

The Shockwave Medical Lithoplasty System combines traditional balloon angioplasty with lithotripsy, or the use of ultrasound shock waves typically used to break up kidney stones. It breaks up both superficial and deep vascular calcium using intermittent shock wave pulses, while the angioplasty balloon restores blood flow, according to the company.

Peripheral artery disease affects as many as 9 million people in the U.S., according to the American Heart Association. It is characterized by narrowed blood vessels that limit blood flow to the limbs and commonly causes pain in the legs. Arterial calcification, or the hardening of arterial plaque, is rising in PAD patients, but current treatments are limited in how they can treat patients with calcified plaques, Shockwave said in the statement.

“Existing devices for treating these patients have significant shortcomings that make it challenging to successfully open arteries, while minimizing vascular injury and complications,” said Dr. Kenneth Rosenfield, section head for Vascular Medicine and Intervention at Massachusetts General Hospital, in the statement “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.”

The FDA clearance comes after a single-arm, two-phase, multicenter study that found the device was safe, was consistently successful in all patient subgroups, immediately and significantly increased blood flow in treated vessels and caused minimal vessel injury, according to the statement.

Shockwave plans a limited U.S. launch for the Lithoplasty System next year and will start a global randomized trial to collect more data.