Cardiovascular Systems will feature one-year data from the ORBIT II study of the company’s Diamondback 360 coronary orbital atherectomy system. The study, which is one of the first to investigate treating severely calcified lesions, will be presented at the 2014 American College of Cardiology conference in Washington, DC, March 29–31, 2014.
This data, along with physician presentations that include case studies and commercial data, are part of Cardiovascular System’s series of in-booth live talks at the American College of Cardiology Conference.
The pivotal ORBIT II study evaluated the safety and effectiveness of the company’s orbital atherectomy technology in coronary arteries. Cardiovascular Systems completed ORBIT II enrolment of 443 patients at 49 US medical centres in November 2012. On October 21, 2013, the company received premarket approval from the US Food and Drug Administration (FDA) to market its Diamondback 360 coronary orbital atherectomy system as a treatment for severely calcified coronary arteries.