ST. PAUL, Minn. & WASHINGTON--(BUSINESS WIRE)--
Cardiovascular Systems, Inc. (CSI) (NASDAQ: CSII), today released 1-year results from its Coronary Orbital Atherectomy System Study (COAST) in a late-breaking presentation at the 2017 Cardiovascular Research Technologies (CRT) conference in Washington, D.C.
The COAST study is CSI’s prospective, single-arm, multi-center, global IDE trial to evaluate the safety and efficacy of the company’s next-generation Micro Crown orbital atherectomy technology in treating patients with severely calcified coronary lesions. It follows the pivotal ORBIT II trial of the company’s Diamondback 360® Coronary OAS Classic Crown, which received PMA approval from the U.S. Food and Drug Administration (FDA) in 2013 as a primary treatment for severely calcified coronary arteries when facilitating stent delivery. CSI completed COAST enrollment of 100 patients, including 74 patients at 12 sites in the United States and 26 patients at five sites in Japan, in July 2015.
Dr. Samin K. Sharma, Mount Sinai Medical Center, N.Y., presented the 1-year results including freedom from major adverse cardiac events (MACE), as well as target lesion revascularization (TLR) at one year after the procedure. Additional authors on the abstract are: Dr. Shigeru Saito, Shonan Kamakura General Hospital, Kamakura, Japan; Dr. Richard A. Shlofmitz of St. Francis Hospital in Roslyn, N.Y.; and Dr. Gregg Stone, Columbia University Medical Center, N.Y.
COAST 1-year outcomes as compared to 30-day outcomes:
|
30-Day |
1-Year |
|||||
| Freedom from MACE | 85.0% | 77.8% | ||||
| MI (defined as CK-MB >3x ULN) | 14.0% | 14.0% | ||||
| Non Q-wave | 12.0% | 12.0% | ||||
| Q-wave | 2.0% | 2.0% | ||||
| Target Vessel/Lesion Revascularization | 1.0% | 9.4% | ||||
| TLR | 1.0% | 6.3% | ||||
| Cardiac Death | 1.0% | 1.0% | ||||
“Incidence of severe coronary arterial calcium is significant and underappreciated,” said Dr. Sharma. “These 1-year results from the COAST IDE Study resulted in 77.8% freedom from 1-year MACE, therefore concluding that the Diamondback 360° Coronary OAS Micro Crown technology may address this unmet treatment need for this difficult to treat population.”
Said Scott Ward, CSI chairman and chief executive officer, “We look forward to seeing how this 1-year COAST data will further impact the treatment of patients with severe coronary arterial calcium. It is important and necessary as we continue to seek device approval in the U.S. and Japan.”
More information about the study design is available at www.ClinicalTrials.gov; identifier: NCT02132611.
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% 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 the first
510(k) clearance for the use of the Orbital Atherectomy System in
peripheral arteries in August 2007. In October 2013, the company
received FDA approval for the Coronary Orbital Atherectomy System. To
date, over 290,000 of CSI’s devices have been sold to leading
institutions across the United States. The Coronary OAS Micro Crown
is limited by federal law to investigational use and is currently not
commercially available in the United States.
For more information, visit the company’s website at www.csi360.com.
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