December 18, 2013

Doctors at The Ortenzio Heart Center at Holy Spirit perform PA’s first coronary orbital atherectomy using new device

Cardiologists at The Ortenzio Heart Center at Holy Spirit performed Pennsylvania’s first coronary orbital atherectomy using the Diamondback 360® Coronary Orbital Atherectomy System. The Ortenzio Heart Center is the only facility in Pennsylvania and one of about a dozen hospitals nationwide that is approved to use this device.

The use of this diamond-coated device was recently approved by the FDA as a treatment for severely calcified coronary arteries. The device uses centrifugal force to sand away severe calcium blockages in the coronary arteries, enabling the successful placement of a stent to restore blood flow.

Rajesh Dave, MD, FACC, FSCAI, Director, Cardiac Catheterization Laboratories at The Ortenzio Heart Center at Holy Spirit, and Chairman, Department of Cardiology at Holy Spirit Hospital, and Andreas Wali, MD, cardiologist with Capital Cardiovascular Associates, have used this device to treat patients at The Ortenzio Heart Center.

“Calcified coronary artery disease remains a challenge for physicians and is responsible for poor outcomes of patients,” says Dr. Dave. “Orbital atherectomy is the latest technology to treat severe calcified coronary artery blockages safely and effectively. It improves treatment results and long-term outcomes for these high risk patients. I am very excited that we are able to offer this innovative technology to our patients in Central Pennsylvania.”

About Coronary Artery Disease
Coronary Artery Disease (CAD) is a life-threatening condition and the leading cause of death in men and women in the United States. CAD occurs when a fatty material, called plaque, builds up on the walls of arteries that supply blood to the heart. The plaque buildup causes the arteries to harden and narrow (atherosclerosis), reducing blood flow. The risk of CAD increases if a person has one or more of the following: high blood pressure, abnormal cholesterol levels, diabetes, or family history of early heart disease. CAD affects an estimated 16.3 million people in the United States and is the most common form of heart disease. Heart disease claims more than 600,000 lives in the United States each year. 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 significantly higher occurrence of death and major adverse cardiac events (MACE).

About Cardiovascular Systems, Inc.
Cardiovascular Systems, Inc., based in St. Paul, Minn., is a medical device company focused on developing and commercializing innovative solutions for treating vascular and coronary disease. The company’s Orbital Atherectomy Systems treat calcified plaque in arterial vessels throughout the leg and heart in a few minutes of treatment time, and address many of the limitations associated with existing surgical, catheter and pharmacological treatment alternatives. The U.S. FDA granted 510(k) clearance for the use of the Diamondback 360 Orbital Atherectomy System in August 2007. To date, more than 125,000 of CSI’s devices have been sold to leading institutions across the United States. In October 2013, the company received FDA approval for the use of the Diamondback 360 Coronary Orbital Atherectomy System in coronary arteries. For more information, visit the company’s website at www.csi360.com.

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