Shockwave Medical (Fremont, CA) announced that European authorities have given the CE mark for the company’s Lithoplasty balloon catheters for treatment of peripheral artery disease (PAD). The catheters are built similar to traditional balloon catheters but have tiny electrodes that can vibrate rapidly and break up calcified material from vessel walls.
From the point of view of the physician, the procedure is almost the same as before, with a bit of lithotripsy (think of breaking up kidney stones) added before pumping up the balloon. The plaque, having been stressed from the induced vibrations, becomes more pliable and allows the balloon to shape it with greater ease without damaging the vessels themselves.
From the announcement:
CE Mark for Lithoplasty was supported by safety and utility clinical data from the multicenter DISRUPT PAD study, which was presented in November 2014 at the Vascular Interventional Advances (VIVA) Annual Conference in Las Vegas, Nevada. Early results demonstrated safe and effective dilatation of calcified stenosis with no acute failures, very favorable residual stenosis, no major adverse events and no restenosis out to 30 days.