If Shockwave IVL had a personality, we’d like to think that we’d be a bit on the eccentric side. A little unconventional and taking a slightly different path than everyone else. After all, you won’t be successful in introducing a new disruptive technology if you’re marching to the same drumbeat as everyone else.
Which is why we’re excited about the technology’s potential in addressing an unmet need in the treatment of calcium today: eccentricity. Eccentric calcium has challenged current modalities’ ability to adequately modify calcium due to several device-dependent factors. For traditional PTCA balloons, they often expanding the healthy, non-calcified side of the artery, while atherectomy technologies can be subject to wire bias that may often leave rigid calcium on the other side of the vessel untouched.
To begin to address this topic with research, we’re happy to inform that recently at the 2020 EuroPCR e-Course, Prof. Holger Nef (DE) presented the first-ever pooled analysis from the DISRUPT CAD I & II studies comparing angiographic results in concentric and eccentric lesions. He found that coronary IVL was associated with high procedural success and consistent clinical outcomes in both eccentric and concentric calcified lesions, including similar rates of clinical success, residual stenosis and acute gain. As one of the highest rated abstracts submitted to the meeting, his analysis debuted in the “Abstracts & Cases Corner,” and was also featured in a sponsored 5-minute video interview where he talks through the findings. Hope you enjoy the video!
This presentation at PCR comes on the heels of a separate independent Cardiovascular Revascularization Medicine publication looking at a similar analysis with the aid of imaging, entitled, “Intravascular imaging to guide lithotripsy in concentric and eccentric calcific coronary lesions,” published by a team of cardiologists from Careggi University Hospital in Florence, Italy and led by Dr. Alessio Mattesini and Prof. Carlo Di Mario. Their paper similarly concluded that, “A standardized algorithm applying intravascular imaging guidance of IVL facilitated second generation DES expansion delivers excellent immediate lumen expansion and patient outcome, both in concentric and eccentric calcifications.”
Important Safety Information - Coronary IVL
Caution: In the United States, Shockwave C2 Coronary IVL catheters are investigational devices, limited by United States law to investigational use in the DISRUPT CAD III Study. Shockwave C2 Coronary IVL catheters are commercially available in certain countries outside the U.S. Please contact your local Shockwave representative for specific country availability. The Shockwave C2 Coronary IVL catheters are indicated for lithotripsy-enhanced, low-pressure balloon dilatation of calcified, stenotic de novo coronary arteries prior to stenting. For the full IFU containing important safety information please visit: https://swmedstage.wpengine.com/clinicians/international/coronary/shockwave-c2/