Cardiovascular Systems Presents New Late-Breaking Coronary Results at EuroPCR Conference
ORBIT II trial met primary endpoints treating patient population in
which 99.3% of subjects had severely calcified lesions
- 30-day freedom from MACE rate of 89.8 percent
- Procedural success of 89.1 percent (including in-hospital MACE)
New data shows:
- 92.8% of patients experienced no severe angiographic complications at 30 days
- 4.7% final procedure mean residual stenosis (core lab assessed)
ST. PAUL, Minn.--(BUSINESS WIRE)-- Cardiovascular Systems, Inc. (CSII) (CSI) (NASDAQ: CSII), presented 30-day results from its ORBIT II study of coronary artery disease in a late-breaking presentation at the 2013 European Association of Percutaneous Cardiovascular Interventions (EuroPCR) conference in Paris.
ORBIT II is evaluating the safety and effectiveness of the companys orbital atherectomy technology in treating patients with severely calcified coronary lesions. This is the first Investigational Device Exemption study in history to evaluate this problematic subset of patients. CSI completed ORBIT II enrollment of 443 patients at 49 U.S. medical centers in November 2012 and submitted its Premarket Approval application to the FDA on March 15, 2013.
Dr. Jeffrey Chambers of Metropolitan Heart and Vascular Institute, Minneapolis, highlighted new data showing that 92.8 percent of patients were free from severe angiographic complications at 30 days. Additionally, core lab assessed final procedure residual stenosis was 4.7 percent.
Patients who suffer from severely calcified coronary lesions are one of the toughest-to-treat populations, and 30-day ORBIT II results demonstrate that CSIs orbital atherectomy technology may be a practical treatment option, said Dr. Chambers. Patients with moderate-to-severe calcium are more likely to experience major adverse coronary events (MACE), or even death. To have a potential solution for this problem is exciting.
Dr. Chambers also presented the following 30-day data:
|Freedom From MACE (30 Day)||89.8%||Procedural Success||89.1%|
|MI (CK-MB >3x ULN||9.7%||Successful Stent Delivery||97.7%|
|Target Vessel/Lesion Revascularization||1.4%||Less than 50 % residual stenosis||98.6%|
|Cardiac Death||0.2%||In hospital MACE||9.5%|
|MI (CK-MB >3x ULN||9.3%|
According to estimates, moderate-to-severe arterial calcium is present in nearly 40 percent of patients undergoing a percutaneous coronary intervention. 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 MACE.
David L. Martin, CSI president and chief executive officer, said: Coronary arterial calcium is a significantly underestimated problem in medicine today. We are committed to providing physicians with viable treatment options for this devastating disease and we are encouraged by the ORBIT II results, which demonstrate that our orbital technology may provide a solution for these difficult to treat patients.
About Coronary Artery Disease
Coronary Artery Disease (CAD) is a life-threatening condition and 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 several of the following: high blood pressure, abnormal cholesterol levels, diabetes, or family history of early heart disease. CAD affects an estimated 16.8 million people in the United States and is the most common form of heart disease. Heart disease claims more than 600,000 lives, or 1 in 4 Americans, in the United States each year.
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 companys Orbital Atherectomy Systems treat calcified and fibrotic plaque in arterial vessels throughout the leg 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 Orbital Atherectomy System in August 2007. To date, nearly 110,000 of CSIs devices have been sold to leading institutions across the United States. CSI has also completed its ORBIT II Investigational Device Exemption clinical trial to evaluate the safety and effectiveness of its orbital technology in treating coronary arteries. The coronary system is limited by federal law to investigational use and is currently not commercially available in the United States.
For more information, visit the companys website at www.csi360.com.
Cardiovascular Systems, Inc.
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Source: Cardiovascular Systems, Inc.Copyright Business Wire 2013