Shockwave Medical’s Coronary IVL System Gains Breakthrough Status

Shockwave Medical Inc., a pioneer in the development and commercialization of Intravascular Lithotripsy (IVL) to treat complex calcified cardiovascular disease, has received Breakthrough Device Designation from the U.S. Food and Drug Administration (FDA) for its Shockwave IVL System with the Shockwave C² Coronary IVL Catheter, which is currently the subject of an Investigational Device Exemption (IDE) study called DISRUPT CAD III. The Shockwave C² IVL Catheter is a proprietary tool designed to fracture problematic calcium using sonic pressure waves in order to facilitate stent delivery, deployment and optimal expansion, thereby improving blood flow to the heart muscle. 
 
The FDA Breakthrough Device Program is intended to help patients and health care providers receive more timely access to medical devices that have the potential to provide more effective treatment or diagnosis for life-threatening or irreversibly debilitating diseases or conditions. Under the program, the FDA will provide Shockwave Medical with priority review and interactive communication during the Shockwave C² IVL Catheter premarket review phase.
 
“Receiving Breakthrough Device Designation is an important milestone, validating IVL as a unique solution for complex calcified coronary disease,” said Doug Godshall, president and CEO of Shockwave Medical. “Our international customers have responded very positively to Shockwave’s C² since its commercial launch last year, and our team has been working hard to bring this transformational technology to patients with coronary disease in the United States. We are encouraged that the FDA has determined that Shockwave C² qualifies as a Breakthrough Device and we look forward to working collaboratively with the agency so we can make Shockwave C² available as expeditiously as possible.”
 
Coronary artery calcium physically impairs blood flow and restricts artery dilation, which inhibits stent expansion¹ and is perhaps the single most important predictor of restenosis and early stent thrombosis,² or coronary artery re-narrowing and blood clots, within the stent after-stent procedures.
 
DISRUPT CAD III is a prospective, non-randomized, multicenter global IDE study to demonstrate the safety and effectiveness of the Shockwave IVL System with the Shockwave C² Coronary IVL Catheter in de novo, calcified, stenotic, coronary arteries prior to stenting. The study is approved to enroll 442 patients at 50 centers in the United States and Europe, and is led by co-principal investigators Drs. Dean Kereiakes and Jonathan Hill. As reported in the company’s second quarter earnings call, the study had enrolled 108 patients as of June 30, 2019.
 
Shockwave C² Coronary IVL catheters are commercially available for the treatment of de novo coronary artery disease in Europe and select other geographies; they are limited to investigational use in the United States.
 
References
¹ Chambers JW, et al. J Am Coll Cardiol Intv 2014; 7:510–8.
² Généreux P, et al.  J Am Coll Cardiol 2014;63:1845–54.