Shockwave Medical is the first-ever manufacturer of coronary IVL products — the most studied and frequently used calcium modification strategy1 in our field. Our commitment to clinical research, continuous innovation and meaningful physician collaboration has set a new standard of care that is shaping the future of treating calcified coronary artery disease.
1: Neel Butala et al. "Use of Calcium Modification During Percutaneous Coronary Intervention After Introduction of Coronary Intravascular Lithotripsy" Journal of the Society for Cardiovascular Angiography & Interventions. 2024; DOI: 10.1016/j.jscai.2023.101254.
Coronary IVL is now the most frequently used coronary calcium modification strategy for treatment of calcified coronary lesions. An analysis of the National Cardiovascular Data Registry CathPCI Registry demonstrates a steady, significant increase in usage since the device's U.S. commercial launch in 2021, showcasing a previous unmet need for a safe, effective and intuitive calcified lesion preparation strategy.
Coronary IVL has been included as a device consideration in a SCAI treatment algorithm for concentric, eccentric, focal and nodular coronary calcification. In a first-of-its kind expert consensus statement, the The Society for Cardiovascular Angiography and Interventions (SCAI) reinforces coronary IVL's consistent, clinically-demonstrated efficacy regardless of calcium morphology.3, 4 In addition, the experts conclude that coronary IVL can be used synergistically with atherectomy devices, especially in balloon uncrossable lesions or longer lesions with heterogeneous calcium and vessel size.
1: Neel Butala et al. "Use of Calcium Modification During Percutaneous Coronary Intervention After Introduction of Coronary Intravascular Lithotripsy" Journal of the Society for Cardiovascular Angiography & Interventions. 2024; DOI: 10.1016/j.jscai.2023.101254.
2: Robert Riley et al. "SCAI expert consensus statement on the management of calcified coronary lesions." J Soc Cardiovasc Angiogr Interv. 2024.
3: Ziad Ali et al. "Safety and Effectiveness of Coronary Intravascular Lithotripsy for Treatment of Calcified Nodules." JACC Cardiovasc Interv. 2023.
4: Ziad Ali et al. "Impact of Calcium Eccentricity on the Safety and Effectiveness of Coronary Intravascular Lithotripsy: Pooled Analysis From the Disrupt CAD Studies." Cardiovascular Interv. 2023.
We've significantly grown dedicated reimbursement pathways since launching coronary IVL in early 2021.
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