FDA Grants Premarket Approval of Shockwave Medical’s IVL for Treatment of Severely Calcified Coronary Artery Disease

February 16, 2021—Shockwave Medical, Inc. announced that the FDA has granted premarket approval for their intravascular lithotripsy (IVL) sonic pressure wave therapy to treat severely calcified coronary artery disease. 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.

The Journal of the American College of Cardiology recently published the results of the Disrupt CAD III study that assessed the use of the IVL in severely calcified de novo coronary lesions. The study confirmed that coronary IVL met both the primary safety and effectiveness endpoints with a low rate of major adverse events and a high rate of procedural success. The technology reportedly demonstrated a low risk of complications that have been associated with the use of high-pressure balloons and atherectomy technologies.

Dean Kereiakes, MD, FACC, FSCAI, President of The Christ Hospital Heart and Vascular Institute, and Professor of Clinical Medicine at the Ohio State University, is Coprincipal Investigator of the pivotal Disrupt CAD III study.

“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.”

The Shockwave IVL was previously designated a Breakthrough Device by the FDA. The technology has been cleared for the treatment of peripheral artery disease in the United States since 2016.