News Release Details
Shockwave Intravascular Lithotripsy FDA Approved to Treat Advanced Heart Disease
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.
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
The approval comes on the heels of its
“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
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
Shockwave is focused on developing and commercializing products intended to transform the way calcified cardiovascular disease is treated. Shockwave aims to establish a new standard of care for the interventional treatment of atherosclerotic cardiovascular disease through differentiated and proprietary local delivery of sonic pressure waves for the treatment of calcified plaque, which the company refers to as Intravascular Lithotripsy (IVL). IVL is a minimally invasive, easy-to-use and safe way to significantly improve patient outcomes. To view an animation of the IVL procedure and for more information, visit www.shockwavemedical.com.
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Source: Shockwave Medical, Inc.