Shockwave sound wave balloon bags CE mark for coronary artery disease

Shockwave Medical, which markets a system that delivers ultrasound shockwaves to treat peripheral artery disease, has notched a CE mark, this time for the treatment of coronary artery disease.

The company’s lithoplasty technology combines balloon angioplasty—which is traditionally used to widen narrowed arteries—with lithotripsy, the use of ultrasound waves typically used to break up kidney stones. The shock wave pulses break up calcified plaques that cause arteries to narrow, while the balloon restores blood flow.

It’s Shockwave Medical Lithoplasty System earned a CE mark in 2015 and FDA clearance in 2016 for the treatment of peripheral artery disease. The new CE mark allows the Shockwave Medical Coronary Lithoplasty System to be used alongside stenting in the treatment of coronary artery disease, according to a statement.

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“The use of Lithoplasty in the coronary arteries is an important new option that has shown, in the DISRUPT CAD I clinical study of the device, to effectively prepare the vessel for stent implantation with minimal complications. I look forward to commercial availability of the system,” said Jean Fajadet, M.D., of Clinique Pasteur in Toulouse, France, who was the coprincipal investigator of the study.

The DISRUPT CAD I trial is a premarket, prospective, single-arm study taking place at seven sites in Europe and Australia. It is evaluating the use of lithoplasty to treat calcified arteries in CAD patients before they receive a drug-eluting stent. Shockwave will share six-month data from the study this week at EuroPCR.

Coronary artery disease, the most common heart disease, kills more than 370,000 people each year, according to the CDC. Calcified arteries are common in people with CAD, and they are correlated with an increased risk of cardiac events. Calcified CAD results in “suboptimal” outcomes for all treatment options, including medical therapy, surgery and interventional treatment, such as stenting, according to the statement.