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    The content on this page is not current guidance and is only for the purposes of the consultation process.

    Unmet need

    Addressing calcified coronary lesions during PCI presents a significant challenge. Calcified plaques can hinder stent deployment and expansion, increasing the risk of complications such as arterial dissection or inadequate stent expansion. Existing options for managing heavily calcified coronary arteries during PCI such as balloon angioplasty may not be effective in fracturing severe calcifications. By using sonic waves to fracture calcium deposits, IVL may be an efficient approach to managing calcified coronary arteries and may lead to better stent placement and improved patient outcomes.