Shockwave Medical said today that it won CE Mark approval in the European Union for its coronary Lithoplasty system. The therapy is designed to treat calcified coronary artery blockages with lithotripsy – sonic pressure waves that are traditionally used to treat patients with kidney stones.
The approval was supported by clinical data from the Disrupt CAD I study, which evaluated the system’s efficacy as a treatment for calcified coronary arteries prior to drug-eluting stent implantation.
“Cardiovascular calcification presents a persistent treatment challenge for the interventionalist,” co-principal investigator Dr. Jean Fajadet said in prepared remarks. “The use of Lithoplasty in the coronary arteries is an important new option that has shown, in the Disrupt CAD I clinical study of the device, to effectively prepare the vessel for stent implantation with minimal complications. I look forward to commercial availability of the system.”
“CE Mark for the Coronary Lithoplasty System is an important milestone for Shockwave Medical,” CEO Doug Godshall added. “With this achievement, we are a step closer to bringing Lithoplasty to patients and physicians in Europe as a potentially paradigm-changing technology for the treatment of coronary artery disease. We look forward to sharing our final 6-month results from Disrupt CAD I at EuroPCR this week, and to continuing to gather clinical evidence on the benefits of this promising treatment for a challenging patient population.”