ST. PAUL, Minn. & ORLANDO, Fla.--(BUSINESS WIRE)--Cardiovascular Systems, Inc. (CSI) (NASDAQ: CSII), today shared three-year results from its pivotal ORBIT II study in a featured clinical research presentation at the 2016 Society for Cardiovascular Angiography and Interventions (SCAI) conference in Orlando, Florida.
The ORBIT II study evaluated the safety and efficacy of the company’s Diamondback 360® Coronary Orbital Atherectomy System (OAS) Classic Crown in treating patients with de novo severely calcified coronary lesions. The complexity of patients studied and the durability of these outcomes are testaments to CSI’s commitment to clinical rigor.
Dr. Jeffrey Chambers, of Metropolitan Heart and Vascular Institute, Mercy Hospital, Minneapolis, presented the final three-year results, including:
|
In Hospital |
30 Day |
1 Year |
2 Year |
3 Year |
|||||||||||
|
MACE |
9.8% | 10.4% | 16.9% | 20.0% | 23.5% | ||||||||||
|
MI (CK-MB > 3X ULN) |
9.3% | 9.7% | 10.6% | 10.9% | 11.2% | ||||||||||
|
Non Q-wave |
8.6% | 8.8% | 9.7% | 10.0% | 10.0% | ||||||||||
|
Q-wave |
0.7% | 0.9% | 0.9% | 0.9% | 1.2% | ||||||||||
|
TVR/TLR |
0.7% |
1.4% | 5.8% | 8.1% | 10.2% | ||||||||||
|
TLR |
|
0.7% | 4.7% | 6.2% | 7.8% | ||||||||||
|
Cardiac death |
0.2% | 0.2% | 3.2% | 4.7% | 6.7% |
|
Kaplan-Meier method used to estimate 30-day to three-year event rates. Certain one- and two-year rates updated at three-year data extract. |
Dr. Chambers said, “Using the coronary OAS to treat calcium prior to stent implantation delivers procedural success and durable long-term outcomes in these complex patients with severely calcified coronary lesions.”
Recent publications have indicated that women are an under-studied population in PCI clinical studies. At SCAI, Dr. Chambers presented the results of an ORBIT II gender sub-analysis in addition to the main three-year results. He concluded, “In the ORBIT II trial, similar rates of MACE through three years post-procedure exist in both males and females. This is significant, and an example of CSI’s thoroughness when conducting clinical studies.”
More information about the ORBIT II study design is available at www.ClinicalTrials.gov.
About Coronary Artery Disease (CAD)
CAD is a
life-threatening condition and a 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.
According to the American Heart Association, 16.3 million people in the
United States have been diagnosed with CAD, 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 and fibrotic 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 Orbital Atherectomy System in
peripheral arteries in August 2007. In October 2013, the company
received FDA approval for the use of the Diamondback Orbital Atherectomy
System in coronary arteries. To date, over 249,000 of CSI’s devices have
been sold to leading institutions across the United States.
For more information, visit the company’s website at www.csi360.com.