Cardiovascular Systems, Inc. (CSI) CSII -.00% , today announced that it has received PMA approval from the U.S. Food and Drug Administration (FDA) to market its Diamondback 360(R) Coronary Orbital Atherectomy System (OAS) as a treatment for severely calcified coronary arteries.

"Today is a landmark moment for: patients suffering from calcified coronary artery disease, their families, our physician operators and everyone at CSI," said David L. Martin, President and Chief Executive Officer of Cardiovascular Systems. "FDA approval of our Diamondback 360 Coronary OAS allows us to bring to market the first new coronary atherectomy system in more than two decades."

According to estimates, significant arterial calcium is present in nearly 40 percent of patients undergoing a percutaneous coronary intervention (PCI). Significant calcium contributes to poor outcomes and higher treatment costs in coronary interventions when traditional therapies are used, including a substantially higher occurrence of death and major adverse cardiac events (MACE). This approval opens up a large, underserved U.S. market opportunity for CSI, estimated to exceed $1.5 billion annually.

Martin continued, "Severe coronary arterial calcium is an underestimated problem in medicine, with limited options for treatment. The ORBIT II trial proved our Diamondback technology is safe and effective in treating this complex disease. Securing coronary approval is another key milestone in our mission to provide primary tools for vascular intervention. I'm proud of our principal physician investigators and scientific teams. Together, with the CSI team we're excited to move forward to help a larger physician population treat these previously underserved patients."

"Coronary calcium is undertreated in the cardiac cath lab. Having a user-friendly device available to effectively treat severe coronary calcium may increase the safety of CAD interventions for this difficult to treat population, while improving long-term patient prognoses," said Dr. Gregg Stone, Professor of Medicine, Columbia University, Director of Cardiovascular Research and Education Center for Interventional Vascular Therapy New York Presbyterian Hospital/Columbia University Medical Center and Co-Director of The Cardiovascular Research Foundation New York, N.Y.

Clinical Data Backs Systems' Effectiveness

ORBIT II is CSI's study evaluating the safety and effectiveness of the company's orbital atherectomy technology in treating the problematic subset of patients with severely calcified coronary lesions. It is the first study in history that sought approval for treating these lesions.

Led by Principal Investigator, Jeffrey Chambers, MD, of Metropolitan Heart and Vascular Institute, Minneapolis, ORBIT II demonstrated that CSI's technology produced clinical outcomes that exceeded the trial's two primary safety and efficacy endpoints by a significant margin--within one of the most challenging patient populations.

At 30 days, ORBIT II results showed patient freedom from MACE was 89.8 percent and procedural success was 89.1 percent. Excluding in-hospital MACE, procedural success was 98.6 percent with 97.7 percent of stents successfully delivered. Moreover, 92.8 percent of patients were free from severe angiographic complications, and core lab assessed final procedure residual stenosis was 4.7 percent.

According to Dr. Chambers, "Patients who suffer from severely calcified coronary lesions are one of the toughest-to-treat populations--and previous studies have shown these patients have worse outcomes. Thirty-day ORBIT II results demonstrate that CSI's orbital atherectomy technology is safe and effective. With FDA's approval, physicians now have new technology to treat patients with severely calcified coronary lesions."

The Diamondback 360 Coronary OAS uses an electrically driven 1.25 mm diamond-coated crown to safely reduce calcified lesions in coronary blood vessels. This ultimately helps enable successful stent deployment, which facilitates more favorable patient outcomes.

Coronary Rollout Strategy

CSI will begin a controlled commercial launch of its Diamondback 360 Coronary OAS immediately.

Said Martin, "Our initial coronary rollout will be very targeted. With a dedicated team of coronary sales specialists, we will focus on a limited number of the top medical institutions in the United States and continue that strategy for several quarters. During that time, we'll focus on providing physicians with a quality experience and on driving adoption in those accounts. Additionally, we'll conduct post-market studies to enhance our product offering and further build our body of clinical data."

CSI will provide more details on FDA approval and its launch plans for the Diamondback 360 Coronary OAS during its upcoming fiscal 2014 first-quarter results conference call.