Shockwave Medical Inc.’s sonic pressure wave therapy has received Pre-Market Approval for severely calcified coronary artery disease from the U.S. Food and Drug Administration (FDA).
 
The technology, which was granted Breakthrough Device designation by the FDA, is a novel application of lithotripsy, an approach that has been used for decades to safely break up kidney stones. With this approval, IVL is now commercially available in the United States to treat problematic calcium in the coronary arteries, which can reduce blood flow in the heart.
 
As coronary artery disease progresses, plaque in the arterial wall often evolves into calcium deposits, which narrow the artery and restrict blood flow. These bone-like structures make the artery rigid and more difficult to reopen with conventional treatments including balloons, which attempt to crack the calcium when inflated to high pressure, and atherectomy, which drills through the calcium to open the artery. While atherectomy has been available for several decades, its use remains low, despite the high prevalence of calcium, due to its complexity of use and potential to result in adverse patient outcomes.
 
How the Technology Works
Intravascular Lithotripsy uses sonic pressure waves, also known as shockwaves, that pass through soft arterial tissue and preferentially disrupt calcified plaque by creating a series of micro-fractures. 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 coronary technology has been widely adopted internationally and is now available in 50 countries, with more than 25,000 patients successfully treated since the initial commercial availability in early 2018.
 
“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 Dean Kereiakes, M.D., FACC, FSCAI, president of The Christ Hospital Heart and Vascular Institute, professor of Clinical Medicine, The Ohio State University, and the co-principal investigator of the pivotal Disrupt CAD III U.S. study. “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.”
 
Relevant Study
The approval comes on the heels of its U.S. pivotal study recently published in the Journal of the American College of Cardiology (JACC), which 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.
 
Notably, coronary IVL was simple to use and demonstrated a low risk of rare but life-threatening complications that have been associated with the use of high-pressure balloons and atherectomy technologies, including tears in the artery, abrupt arterial closure and a sudden stop of blood flow.
 
“Obtaining FDA approval for this transformational technology marks a significant advance in the treatment of patients with calcified coronary lesions, and is the culmination of years of technical research, rigorous clinical studies and key learnings from our real-world global experience,” said Doug Godshall, president and chief executive officer of Shockwave Medical. “We are eager for U.S. cardiologists to have access to this technology and experience how a safe, efficient and predictable calcium modification strategy can positively impact their clinical outcomes.”
 
The Shockwave IVL System with the Shockwave C2 Coronary IVL Catheter is indicated for lithotripsy-enabled, low-pressure balloon dilatation of severely calcified, stenotic de novo coronary arteries prior to stenting in the United States. The technology has been cleared for the treatment of peripheral arterial disease in the United States since 2016.