Cardiovascular Systems presented three-year data from its ORBIT I feasibility study of calcified coronary lesions during a poster session at the 2013 Cardiovascular Research Technologies (CRT; 23–26 February 2013, Washington, USA) conference.
According to a company press release, results demonstrated CSI’s Orbital atherectomy system was associated with a 97% procedural success rate. The press release added that the study showed low event rates up to three years post procedure.
The ORBIT I study evaluated the safety of CSI’s orbital atherectomy system as a treatment for mild-to -severe calcified coronary arteries. Results from the 50-patient feasibility trial formed the basis for the ORBIT II pivotal trial. This three-year feasibility data shows that using CSI’s technology to treat calcified coronary arteries before stenting achieved not only early procedural success but also positive long-term outcomes.
“This case series demonstrates that CSI’s system can safely modify calcified lesions and facilitate stent delivery in this subset of difficult-to-treat patients,” said presenter Stevan Himmelstein, Baptist Memorial Hospital-Desoto, Memphis, Tenn. “Coronary artery disease is the leading cause of death for men and women in the United States. To have a potential solution for this pressing problem is encouraging.”
The ORBIT I study consisted of 50 patients enrolled at two sites in India from May to June 2008. All subjects had at least one calcified coronary lesion with stenosis between 50% and 100%. Thirty-three of the 50 patients were enrolled at one of the two sites and were followed for three years post procedure. The evaluated safety endpoint was major adverse cardiac event (MACE) rates.