Cardiovascular Systems will release one-year data from the ORBIT II study of the company’s Diamondback 360 coronary orbital atherectomy system in treating severely calcified lesions. The data will be presented as an iMPACT Trial at the 2014 Cardiovascular Research Technologies conference in Washington, DC, USA (February 22-25, 2014).
According to a press release, the ORBIT II pivotal study evaluated the safety and effectiveness of the orbital atherectomy technology. 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.