Cardiovascular Systems is expected to present late-breaking data from its ORBIT II study of coronary artery disease at EuroPCR in Paris, France, 21–24 May.
ORBIT II evaluated the safety and effectiveness of the company’s orbital atherectomy technology in treating patients with severely calcified coronary lesions. According to the company, this is the first investigational device exemption study in history to evaluate this difficult-to-treat subset of patients. Cardiovascular Systems reported that ORBIT II enrollment of 443 patients at 49 US medical centres in November 2012 had been completed and submitted a premarket approval application to the US Food and Drug Administration (FDA) on 15 March 2013.
According to estimates, which were reported in a company press release, moderate-to-severe arterial calcium is present in nearly 40% of patients undergoing a percutaneous coronary intervention. Calcium can contribute to poor outcomes and higher treatment costs in coronary interventions when traditional therapies are used, including a significantly higher occurrence of death and MACE, according to the company.
EuroPCR late-breaking trial results presentation is expected to take place on 23 May. Jeffrey W Chambers, Metropolitan Heart and Vascular Institute, Minneapolis, USA is expected to present “Pivotal trial to evaluate the safety and efficacy of the Diamondback 360° Orbital Atherectomy System in treating de novo, severely calcified coronary lesions (ORBIT II)”.