The Shockwave Coronary Lithoplasty System helps to place stents into coronary arteries in patients that have substantial calcified plaque. Lithoplasty 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.
Lithoplasty Technology utilises a treatment system which includes Lithoplasty Technology Balloon Catheters, a connector cable and generator. These are familiar devices for interventionalists, making the technology inherently familiar, easy to learn, adopt, and use on a day-to-day basis. Lithoplasty Balloon Catheters are prepared and delivered exactly like traditional balloon angioplasty devices. The catheters have proximal and distal markers, so they can be accurately placed within the lesion.
At the touch of a button, miniaturised lithotripsy emitters apply pulsatile mechanical energy along the length and diameter of the balloon. The balloon catheter easily attaches to the connector cable. Lithotripsy pulsing is activated by pushing a button on the connector cable. Disruption starts with a pulse.
The small, battery-powered rechargeable generator is linked to the balloon catheter via the connector cable. A chip in the catheter provides pre-set lithotripsy delivery parameters, so no dials or settings need to be adjusted.
Safety and performance
Safety and performance was supported by clinical data from results conducted at seven centres in Europe and Australia. The study evaluated the safety and performance of the Shockwave Coronary Rx Lithoplasty® System when used to pre-treat calcified, stenotic coronary arteries prior to stenting. The study was a prospective, single-arm, multi-centre study. 60 subjects were enrolled in the EU and Australia to undergo Coronary Rx Lithoplasty® treatment prior to coronary stent placement. The Coronary Rx Lithoplasty® System comprises a novel combination of an angioplasty balloon with lithotripsy technology. The lithotripsy technology generates pulsatile mechanical energy within the coronary artery with the intention of disrupting calcium deposits. The disruption of calcium allows for the subsequent dilation of the artery using an angioplasty balloon at lower pressure and prior to stent placement.
It is considered that the dilation of coronary arteries using a low pressure balloon, should result in less vascular injury and thus better patient outcomes in those patients with troublesome, calcified coronary arteries. The Shockwave Coronary Rx Lithoplasty® System is based on the same technology as the Shockwave Lithoplasty® System which is approved for the treatment of peripheral artery disease.
Patients received Lithoplasty treatment prior to placement of coronary stent. Patient were followed for patency at discharge, 30 days and 6 months following treatment. 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 in 2016 at the annual Transcatheter Cardiovascular Therapeutics (TCT) conference in Washington, D.C.
Edited by John Sandham