Intravascular lithotripsy system for calcified CAD gains FDA approval
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Shockwave Medical announced its intravascular lithotripsy system received premarket approval from the FDA for the treatment of calcified CAD.
The intravascular lithotripsy system (Shockwave IVL, Shockwave) is designed to fracture problematic calcium using sonic pressure waves, an approach that has been used for decades to safely break up kidney stones, to facilitate stent delivery, deployment and optimal expansion, according to a press release from the company.
“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,” Doug Godshall, president and CEO of Shockwave Medical, said in the release. “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.”
As Healio previously reported, use of intravascular lithotripsy among patients with severely calcified lesions was associated with low rates of 30-day MACE and high rates of procedural success, according to the 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,” Dean Kereiakes, MD, FACC, FSCAI, president of The Christ Hospital Heart and Vascular Institute, professor of clinical medicine at The Ohio State University, and the co-principal investigator of the DISRUPT CAD III study, said in the release. “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.”
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