The innovative technology is a novel application of lithotripsy, an approach that has been used for decades to safely break up kidney stones. With this approval, the Shockwave IVL is now commercially available in the United States to treat problematic calcium in the coronary arteries.
According to the company, the coronary technology is available in 50 countries, with more than 25,000 patients successfully treated since the initial commercial availability in early 2018. IVL uses sonic pressure waves that pass through soft arterial tissue and disrupt calcified plaque by creating a series of microfractures. After the calcium has been cracked, the artery can be expanded at low pressure and a stent safely implanted to improve blood flow, with minimal trauma to normal arterial tissue.
“Coronary calcification is a major challenge for physicians because it limits the success of coronary angioplasty procedures and our current tools for addressing calcium have limitations,” said Dr. Kereiakes. “This approval represents a major advance in both the safety and simplicity of some of our most challenging procedures—and potentially promises to become a new standard of care.”