Results Presented for Shockwave Medical's Lithoplasty System in Calcified CAD

November 7, 2016—Shockwave Medical announced the presentation of positive safety, performance, and intravascular imaging data from the DISRUPT CAD study, which evaluated the company’s coronary Lithoplasty system to treat calcified coronary artery disease (CAD) before drug-eluting stent (DES) implantation. The data were presented at TCT 2016, the 28th annual Transcatheter Cardiovascular Therapeutics scientific symposium held October 29 to November 2 in Washington, DC. 

DISRUPT CAD is a premarket, prospective multicenter, single-arm study conducted at seven centers in Europe and Australia. The study enrolled 60 patients with complex calcified obstructive CAD, with 80% of patients classified as having severe calcification.

According to the company, acute performance results showed high device success (98%) and excellent angiographic outcomes, in particular, a large acute gain in vessel diameter (1.7 mm) and low residual percent stenosis (13%) postprocedure. Safety results demonstrated minimal vascular injury, with no incidence of perforation, abrupt closure, or slow/no-reflow events. The rate of major adverse cardiac events at 30 days was low (5%), with all events being non–Q-wave myocardial infarction.

Intravascular imaging using optical coherence tomography was performed on 31 of 60 patients and demonstrated that calcium was fractured completely through all calcified layers of the artery and around the circumference of the artery. The resulting gain in luminal area after treatment was significant and was achieved independently from the degree of calcification, stated Shockwave Medical.

The Principal Investigators of the study were Jean Fajadet, MD, Codirector of the Interventional Cardiovascular Group at Clinique Pasteur in Toulouse, France and Carlo Di Mario, MD, Professor of Clinical Cardiology at Royal Brompton Hospital in London, United Kingdom.

Dr. Fajadet commented in the company’s press release, “These early results of Lithoplasty in the coronary arteries are highly encouraging, particularly considering the severity of calcification of the patients enrolled in the trial. Calcification in cardiovascular arteries creates numerous treatment challenges. These data demonstrate an effective preparation of the vessel for stent implantation with minimal complications. In addition, because the device is a balloon, the technical challenges associated with treating these complex patients are significantly reduced.” 

Shockwave Medical’s coronary Lithoplasty system is an investigational device and is not available for sale. The company’s peripheral Lithoplasty system is commercially available in the European Union and the United States for treatment of peripheral vascular disease.