ORBIT II trial met its primary endpoints treating one of the most challenging patient populations:

• 100 percent of patients had severe coronary calcification—a patient subset never before studied
• At 30 days, patient outcomes exceeded the study’s primary safety and efficacy endpoint targets by a significant margin
  • 30-day freedom from MACE rate of 89.8 percent
  • Procedural success of 89.1 percent (including in-hospital MACE)
    

ST. PAUL, Minn. & SAN FRANCISCO-- Cardiovascular Systems, Inc. (CSI), presented pivotal 30-day data from its ORBIT II study of severely calcified coronary lesions at the 2013 American College of Cardiology (ACC) conference in San Francisco. The Featured Clinical Research session presentation by Dr. Jeffrey Chambers of Metropolitan Heart and Vascular Institute, Minneapolis, demonstrated that CSI’s technology produced clinical outcomes that exceeded the trial’s two primary endpoints by a significant margin—within one of the most challenging patient populations to treat.

ORBIT II is evaluating the safety and effectiveness of the company’s 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. According to estimates, moderate to severe arterial calcium is present in nearly 40 percent of patients undergoing a percutaneous coronary intervention. CSI completed ORBIT II enrollment of 443 patients at 49 U.S. medical centers in November 2012.

Dr. Chambers presented the following 30-day data: 

Read the full abstract here.

“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 Dr. 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.”

Moderate-to-severe calcium contributes to poor outcomes and higher treatment costs in coronary interventions when traditional therapies are used, including a significantly higher occurrence of death and major adverse coronary events (MACE). Coronary approval would open up a large, underserved market opportunity for CSI, estimated to exceed $1.5 billion annually in the United States. CSI is targeting the end of March to submit its Premarket Approval (PMA) application to the Food and Drug Administration (FDA).

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.”

Source: Cardiovascular Systems, Inc.