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