Shockwave Medical's Coronary Lithoplasty System Receives CE Mark Approval
May 15, 2017—Shockwave Medical, Inc. announced European CE Mark approval for the company’s coronary Lithoplasty system for the treatment of calcified plaque in conjunction with stenting in patients with coronary artery disease. The device uses lithotripsy, sonic pressure waves historically used to treat patients with kidney stones, to treat calcified coronary artery blockages.
The safety and performance of the device was supported by clinical data from DISRUPT CAD I, which evaluated the use of the coronary Lithoplasty system as a treatment for calcified coronary arteries before drug-eluting stent implantation. The premarket, prospective, multicenter, single-arm study was conducted at seven centers in Europe and Australia.
Primary endpoint results from the DISRUPT CAD I study were presented at TCT 2016, the 28th annual Transcatheter Cardiovascular Therapeutics scientific symposium held October 29 to November 2 in Washington, DC.
The final 6-month results from DISRUPT CAD I will be presented by Todd Brinton, MD, at EuroPCR 2017, being held May 16–19 in Paris, France. Also at EuroPCR, Dr. Brinton will present first-in-human results of a study of lithotripsy for the transcatheter treatment of aortic valve stenosis, noted the company.
Jean Fajadet, MD, who is Co-Director of the Interventional Cardiovascular Group at Clinique Pasteur in Toulouse, France, served as Co-Principal Investigator of the DISRUPT CAD I clinical trial. In Shockwave Medical's announcement, Dr. Fajadet commented, "Cardiovascular calcification presents a persistent treatment challenge for the interventionist. 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.”