Shockwave Medical out of Fremont, California won the European CE Mark to introduce its Coronary Lithoplasty System for helping to place stents into coronary arteries in patients that have substantial calcified plaque. Lithoplasty is Shockwave’s name for its technology (aka lithotripsy) that delivers sonic waves via a specialty catheter directly to the plaque lining blood vessels. The vibration pressures help to create cracks within the plaque, allowing a balloon to compress it more and create a wider lumen. This in turn gives more space for a stent to be positioned, allowing more blood perfusion through the treated region.
The Coronary Lithoplasty System combines the lithotripsy transducers that create the sound waves and a traditional balloon in one device, which essentially retains the same workflow as traditional balloon angioplasties.
A little detail about the data that led to this regulatory clearance:
Safety and performance was supported by clinical data from results of DISRUPT CAD I, a pre-market, prospective multi-center single-arm study conducted at seven centers in Europe and Australia. The study evaluated the use of the Shockwave Medical Coronary Lithoplasty System as a treatment for calcified coronary arteries prior to drug eluting stent (DES) implantation. Primary endpoint results from the study were reported last fall at the annual Transcatheter Cardiovascular Therapeutics (TCT) conference in Washington, D.C.
Here’s an animation showing the functionality of the Lithoplasty system, though in this case for peripheral artery disease:
Via: Shockwave Medical…