Shockwave Coronary IVL System
IVL Alleviates the Challenges of Calcified Cardiovascular Disease
Shockwave Coronary Intravascular Lithotripsy (IVL) System
Minimize trauma to soft tissue by safely selectingand fracturing intimal and medial calcium
Optimize stent delivery, expansion and apposition while reducing complications and cost escalation
Simple and intuitive system that makes complex calcified coronary procedures more predictable
Simple & Intuitive IVL System
IVL Connector Cable
Don’t Crack Under Pressure
The IVL Catheter is delivered across a calcified lesion over an 0.014″ wire and the integrated balloon is expanded to 4atm to facilitate efficient energy transfer.
An electrical discharge from the emitters vaporizes the fluid within the balloon, creating a rapidly expanding & collapsing bubble that generates sonic pressure waves.
The waves create a localized field effect that travels through soft vascular tissue, selectively cracking intimal and medial calcium within the vessel wall.
After calcium modification, the integrated balloon may subsequently be used to dilate the lesion at low pressure in order to maximize luminal gain.
DISRUPT CAD Clinical Program Overview
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.
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.
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.
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.
Peripheral Intravascular Lithotripsy System Technology
Shockwave-sponsored DISRUPT PAD Clinical Program
Post-market, European registry examining the ongoing safety and performance of peripheral IVL as standalone therapy in heavily calcified fem-pop lesions followed out to 12 months.
Single-arm, pre-market European study demonstrating the safety and performance of IVL as standalone therapy in heavily calcified, fem-pop lesions and followed to 6 months.
A prospective, randomized, multicenter, study to evaluate the benefit of IVL combined with drug-coated balloons vs standalone DCB in heavily calcified fem-pop lesions followed out to 24 months. It is also includes an all-comers registry arm to assess the real-world acute performance of IVL in lower extremities, including iliac, femoral, fem-pop, popliteal infrapopliteal lesion.
Post-market, European study to assess the safety and effectiveness of IVL in heavily calcified infrapopliteal lesions out to 30 days.
*Products are equivalent, either Catalog Number may be used when ordering and either product may be received. For more information on SHOCKWAVE, please visit- https://shockwavemedical.com/