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

cor cross

Safety

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

cor graph

Effectiveness

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

cor scale

Value

Economic value through the reduction of complications and cost escalation

cor gear

Ease of Use

Seamless integration with consistent outcomes and minimal learning curve

Shockwave-sponsored DISRUPT CAD Clinical Program

cad i
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.
cad ii
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.
cad iii
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.

Clinical Evidence Multimedia Resources

roundtable
Roundtable Discussion
Watch Drs. Ziad Ali, Jonathan Hill and Azeem Latib discuss the initial clinical evidence with the coronary IVL and its experience in more real-world patients.
Watch Discussion
poster presentation
Poster Presentation
Download Dr. Julian Yeoh’s presentation from TCT2018 about extending the use of IVL out of clinical studies and into real-world patients.
Read Perspective
DAIC
Perspective in DAIC
Read Dr. Azeem Latib’s first-hand perspective about using IVL for the first time and itspotential clinical applications.
Read Perspective

Ready to Make Waves with Shockwave IVL?

ico email Connect