ORBIT II trial meets its primary endpoint


ORBIT III, which was presented at the recent ACC meeting, met its primary endpoint and showed that the Orbital atherectomy system (Cardiovascular Systems) was associated with an 89.8% freedom from major adverse cardiovascular events (MACE) rate and a procedural success rate of 89.1% (including in-hospital MACE). 

ORBIT II is evaluating the safety and effectiveness of the orbital atherectomy technology in treating a problematic subset of patients with severely calcified coronary lesions and is the first Investigational Device Exemption (IDE) study in history to seek approval for treating these lesions.

Jeffrey Chambers, of Metropolitan Heart and Vascular Institute, Minneapolis, USA, presented following 30-day data:

  • Freedom from MACE—89.8%
  • Procedural Success–89.1%
  • Successful Stent Delivery–97.7%
  • Target vessel/lesion revascularization–1.4%
  • Less than 50% residual stenosis–98.6%
  • Cardiac death—0.2%                                                         

“While treatment of severely calcified coronary arteries remains a challenge, 30-day ORBIT II results show that study endpoints were met by a significant margin, and demonstrate that CSI’s orbital atherectomy system may be a viable treatment option,” said Chambers. “ORBIT II represents the only study to-date of this hard-to-treat patient population. Past studies haven’t attempted to treat severely calcified lesions, due to the challenge of meeting endpoints and overall treatment success.”

David L. Martin, CSI president and chief executive officer, added: “CSI’s mission is to conquer calcified arterial disease. Coronary arterial calcium is an extremely underserved problem. The ORBIT II study results for this sickest-of-the-sick patient population demonstrate the outstanding performance of our orbital atherectomy technology. We are very excited about the future of our coronary franchise and look forward to continuing down the path for FDA approval of this unique technology.”