Shockwave Medical has completed enrolment in its US Food and Drug Administration (FDA) Investigational Device Exemption (IDE) study—DISRUPT CAD III—for the use of intravascular lithotripsy (IVL) for the management of heavily calcified coronary arteries. A press release reports that the investigational Shockwave IVL system with the Shockwave C2 Coronary IVL catheter, which has been granted Breakthrough Device Designation by the FDA, is an innovative therapy designed to fracture problematic calcium using sonic pressure waves in order to facilitate stent delivery, deployment and optimal expansion.
DISRUPT CAD III is a prospective, multicentre, single-arm, global IDE study to demonstrate the safety and effectiveness of the Shockwave coronary IVL system with the Shockwave C2 coronary IVL catheter in de novo, calcified, stenotic, coronary arteries prior to stenting. The study enrolled 384 patients, exceeding the minimum requirement of 372 patients, per the a priori statistical plan agreed by the FDA. Patients were enrolled at 47 global sites in the USA, France, Germany, and the UK.
The study is assessing freedom from 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 less than 50 percent and without in-hospital MACE.
The study chairman is Gregg W Stone (Icahn School of Medicine, Mount Sinai, New York, USA). The co-principal investigators of the study are Dean Kereiakes (The Christ Hospital Heart and Vascular Center and the Christ Hospital Research Institute, Cincinnati, USA) and Jonathan Hill (Royal Brompton Hospital, London, USA).
Hill says: “We eagerly await the opportunity to share the DISRUPT CAD III results with the global interventional community later this year. IVL has been a significant advance for our management of calcified lesions in Europe and I am excited about the potential for the technology to have a similar impact in helping patients across the USA.”
Doug Godshall, president and CEO of Shockwave Medical, states: “Despite the global challenges of COVID-19, the CAD III investigators, research staff and site monitors have done an outstanding job in bringing this important study to a timely conclusion. Based on recent collaborative interactions with the FDA, it is our expectation that the PMA will be submitted in the third quarter of this year, with US device approval anticipated in the first quarter of 2021, consistent with previous guidance.’’
Shockwave C2 Coronary IVL catheters are commercially available for the treatment of de novo coronary artery disease in Europe and select other geographies; they are limited to investigational use in the United States.