Shockwave Medical is moving to get its Intravascular Lithotripsy (IVL) technology approved in Japan. The Santa Clara-based company said it has initiated the DISRUPT CAD IV study of IVL in heavily calcified coronary arteries.
DISRUPT CAD IV is expected to enroll up to 64 patients at eight sites in Japan. Shockwave Medical pointed out the first CAD IV patient was enrolled earlier this week by the principal investigator of the study, Shigeru Saito, MD, Director of Cardiology and Catheterization Laboratories and Vice President, Shonan Kamakura General Hospital.
The firm’s device is designed to fracture problematic calcium using sonic pressure to facilitate stent delivery, deployment, and optimal expansion, thereby improving blood flow to the heart muscle.
Similar to the DISRUPT CAD III Study protocol, CAD IV will assess the absence of major adverse cardiac events (MACE) 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 <50%, 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.
“Based on the interest, feedback and rapid adoption in other Asia Pacific countries where we have introduced coronary IVL, we are excited for the prospect of providing Japanese physicians with access to this therapy for the first time,” Doug Godshall, president and CEO of Shockwave Medical, said in a release. “Japan holds tremendous potential for IVL, and we look forward to completing the study and working with the regulators so that Japanese patients and their providers will be able to access IVL therapy as soon as possible.”
Shockwave C2 Coronary IVL catheters are commercially available for the treatment of de novo coronary artery disease in Europe. In September, the company received breakthrough device designation from FDA for the Shockwave IVL System with the Shockwave C2 Coronary IVL Catheter.