Sound Evidence for Your Coronary Calcium Strategy

At Shockwave, we’re committed to the creation of sound clinical evidence to support the adoption and long-term utilization of our technology. This includes a balance of high-quality Shockwave-sponsored and investigator-initiated research studies to advance the knowledge of our technology’s performance in daily practice.

Shockwave's Clinical Evidence Pillars

What We Set Out to Demonstrate

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Safety

Consistent safety profile across studies for the patient and within the vessel

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Effectiveness

Highly effective in dilating calcified lesions – from the simple to the complex

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Value

Economic value through the reduction of complications and cost escalation

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Ease of Use

Seamless integration with consistent outcomes and minimal learning curve

Shockwave-sponsored DISRUPT CAD Clinical Program

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Single-arm, pre-market European study demonstrating the safety and performance of IVL in heavily calcified, coronary lesions prior to stenting and followed to 6 months; also included an OCT Sub-study demonstrating IVL’s mechanism of action.
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Post-market, European registry examining the ongoing safety and performance of coronary IVL in heavily calcified coronary lesions up to 30 days in more centers and more patients.
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A prospective, multicenter, single-arm, investigational device exemption (IDE) study to evaluate the safety and effectiveness of the Shockwave Coronary IVL System taking place in the United States, United Kingdom, Germany and France. The goal of this study is to generate the data needed to obtain FDA approval for use of coronary IVL in the United States.
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A prospective, multicenter, single-arm study intended to support regulatory device approval in Japan by investigating the safety and effectiveness of coronary IVL. Caution: In Japan coronary IVL is limited to investigational use within the DISRUPT CAD IV Study.

Clinical Evidence Multimedia Resources

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DISRUPT CAD II Study Discussion
Profs. Carlo Di Mario & Javier Escaned discuss the key takeaways and implications on clinical practice for the DISRUPT CAD II Study.
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EuroPCR19 Roundtable on Coronary IVL
At EuroPCR 2019 Drs. Jonathan Hill, Benjamin Honton and Nikos Werner discuss the best practices and some of the key insights they've garnered using coronary IVL after one year of commercial use in Europe.
Watch Video
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DISRUPT CAD III Insight
Insights from EU Coronary Intravascular Lithotripsy (IVL) Use & Overview of DISRUPT CAD III Study by Dr. Jonathan Hill, Consultant Cardiologist at King’s College in London.
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Ready to Make Waves with Shockwave IVL?

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