ShockWave Medical initiates study of coronary intravascular lithotripsy in Japan
Shockwave Medical (SWAV) announced that the company has initiated the DISRUPT CAD IV study of IVL in heavily calcified coronary arteries that is intended to support regulatory device approval in Japan.
The first CAD IV patient was enrolled earlier this week by the principal investigator of the study, Shigeru Saito, M.D., Director of Cardiology and Catheterization Laboratories and Vice President, Shonan Kamakura General Hospital.
DISRUPT CAD IV is a prospective, multicenter, single-arm study to demonstrate the safety and effectiveness of the Shockwave Coronary IVL System with the Shockwave C2 IVL Catheter in the treatment of de novo, calcified, stenotic, coronary arteries prior to stenting.
The study is expected to enroll up to 64 patients at 8 sites in Japan. Similar to the DISRUPT CAD III Study protocol, CAD IV will assess the absence of major adverse cardiac events within 30 days of the index procedure as the primary safety endpoint.
The primary effectiveness endpoint is procedural success, defined as stent delivery with a residual stenosis less than 50 percent, and without in-hospital MACE.
Study enrollment is expected to be completed by June 2020, from which enrolled patients will be followed for two years. Coronary artery calcium physically impairs stent expansion and is perhaps the single most important predictor of early stent thrombosis and restenosis after stent procedures.ii, iii, iv Coronary IVL is a therapy designed to treat calcified artery blockages with sonic pressure waves historically used to treat patients with kidney stones.
The technology seeks to minimize trauma within the artery by delivering pulsatile sonic pressure waves locally to fracture both intimal and medial calcium in the artery wall but pass through surrounding soft vascular tissue in a safe manner.
Shockwave C2 Coronary IVL catheters are commercially available for the treatment of de novo coronary artery disease in Europe and other select countries; in Japan they are limited to investigational use within the DISRUPT CAD IV Study. In the United States they are limited to investigational use within the DISRUPT CAD III Study.
SWAV closed at $34.83.
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