The FDA-approved shockwave system is a new technology used before implanting a stent to open arteries that are narrowed due to calcification, which is ideal for proper stent placement. Major calcium deposits and the buildup of too much calcium in a patient’s arteries can be so severe a typical stent procedure alone won’t open up the artery. This is ideal for older adults and anyone who has early signs of atherosclerosis (buildup of fats, cholesterol and other substances in and on the artery walls).
Until the availability of Shockwave IVL, the only option to break up that type of calcified plaque was using a small drill, placed in a catheter – a procedure that required an overnight stay. The Shockwave IVL is a minimally invasive catheterization that uses sonic pressure waves to fracture challenging calcium build up in coronary arteries, while minimizing trauma to the patient’s vessel walls.
Highly calcified coronary arteries often cause suboptimal stent expansion, which is one of the greatest predictors of adverse outcomes, such as stent thrombosis and restenosis, which is when the stent fails to stay open either immediately or slowly.
The sonic pressure waves generated by Shockwave IVL can crack calcium in only a few pulses, significantly reducing the risk of complications, making procedures more predictable and efficient, and facilitating cardiac stent delivery, deployment, and optimal expansion. Patients often can return home the same day as the procedure.
According to the FDA, in the Shockwave IVL clinical trial of 384 patients, 92% of them were able to receive the stent and survived without a heart attack or another procedure for 30 days. After one year, approximately 75% of patients had survived without a heart attack or additional procedure.