Cardiovascular Systems, Inc. (CSI) (NASDAQ: CSII), today announced that its new Diamondback 360® Coronary Orbital Atherectomy System (OAS) is being used by physicians across the country to treat coronary artery disease. This follows the company's recent PMA approval from the U.S. Food and Drug Administration (FDA) to market the device as a treatment for severely calcified coronary arteries.
"Significant arterial calcium is present in nearly 40 percent of patients undergoing a percutaneous coronary intervention, and 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," said David L. Martin, CSI's president and chief executive officer. "Severe coronary arterial calcium is a vastly underestimated problem in medicine, with limited treatment options. Our Diamondback 360 coronary system provides for initial therapeutic intervention for this complex disease and we are excited about its growing use, as illustrated by the early adoption and ongoing cases being performed at three U.S. hospitals by prominent physicians. As we continue our controlled product rollout, we expect to see this list of hospitals and prominent physicians expand nationally."
Here is a recap of first cases by the performing physician at each medical center:
Houston Cardiovascular Associates
"Patients with calcified coronary artery disease are one of the toughest populations to treat. CSI's study results demonstrate that the Diamondback Coronary OAS is an effective and safe option for physicians to use when treating severely calcified coronary lesions."
- Dr. Manuel Reyes, Interventional Cardiologist, Houston Cardiovascular Associates, Houston
North Florida Regional Medical Center
"Calcification in the coronary arteries is a sign of advanced disease and translates into higher risk stent procedures; in some circumstances it even necessitates open heart surgery. The Diamondback 360 Coronary OAS gives us the ability to safely and effectively treat these high-risk patients. I fully expect the system will allow widespread uptake of this technology across the country so that all patients will eventually have access to this long-awaited technology."
- Dr. Arthur Lee, Interventional Cardiologist, The Cardiac & Vascular Institute, Gainesville, Fla.
St. Francis Hospital
"There is a pressing need for treatment of calcified coronary lesions, and the Diamondback 360 Coronary OAS addresses that need. CSI's system is safe and effective in treating severely calcified coronary arteries, and, on top of that, it is user-friendly for physicians."
- Dr. Richard Shlofmitz, Director of Cardiology, St. Francis Hospital, Roslyn, N.Y.
The Diamondback 360 Coronary OAS uses a patented combination of differential sanding and centrifugal force to reduce arterial calcium that can cause complications when treating coronary artery disease. It is an eccentrically mounted 1.25-millimeter diamond-coated crown that sands away calcium in coronary arteries, enabling optimal stent deployment. As the crown rotates and orbit increases, centrifugal force presses the crown against the lesion, reducing arterial calcium.
Cardiovascular Systems, Inc.