[July 13, 2015] |
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Cardiovascular Systems Completes Coast Study Enrollment
Cardiovascular Systems, Inc. (CSI (News - Alert)) (NASDAQ: CSII), announced that it has
completed enrollment for its Coronary Orbital Atherectomy System Trial
(COAST) study. Taking place in both Japan and the United States, the
study is designed to assess the safety and efficacy, as well as economic
outcomes, of CSI's new micro crown Orbital Atherectomy System (OAS) in
treating severely calcified coronary lesions in patients suffering from
Coronary Artery Disease (CAD). As designed, a total of 100 patients were
enrolled in the study.
The 1.25 mm micro crown is CSI's second-generation system designed to
facilitate stent delivery in patients with severely calcified lesions
who are acceptable candidates for percutaneous transluminal coronary
angioplasty (PTCA) or stenting. The micro crown OAS is designed to
improve the tracking and piloting of the OAS driveshaft and the ability
of the crown to reach the lesion while operating at lower rotational
speeds.
"Data from this study will be key to secure approval for the use of the
coronary micro crown OAS in the world's two largest atherectomy
markets," said David L. Martin, CSI president and chief executive
officer. "We anticipate that the 30-day data will be presented in
calendar 2016."
COAST builds on CSI's ORBIT II study, the first trial designed to treat
patients with severely calcified lesions who are typically excluded from
all major trials, but commonly seen in the real world. COAST is a
prospective, single-arm, multi-center, global, investigational study.
In November 2014, CSI completed the enrollment of 26 patients at five
sites in Japan. Seventy-four patients were enrolled in 15 sites in the
United States. The study's principal co-investigators are Dr. Shigeru
Saito, Director of Cardiology and Catheterization Laboratories at Shonan
Kamakura General Hospital, Kamakura, Japan and Dr. Gregg Stone, Director
of the Cardiovascular Research and Education Center for Interventional
Vascular Therapy at Columbia University Medical Center, New York.
About Coronary Artery Disease 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 (News - Alert)). 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, nearly 200,000 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.
Safe Harbor Certain statements in this news release are
forward-looking statements within the meaning of the Private Securities
Litigation Reform Act of 1995 and are provided under the protection of
the safe harbor for forward-looking statements provided by that Act. For
example, the statements in this press release regarding (i) the COAST
trial; (ii) approval of the micro crown OAS in the United States and
Japan; and (iii) the timing of the presentation of 30-day data from the
COAST trial, are forward-looking statements. These statements involve
risks and uncertainties that could cause results to differ materially
from those projected, including, but not limited to, the effectiveness
of the micro crown OAS; actual clinical trial and study results;
government clearances and approvals; and other factors detailed from
time to time in CSI's SEC (News - Alert) reports, including its most recent annual
report on Form 10-K and subsequent quarterly reports on Form 10-Q. CSI
encourages you to consider all of these risks, uncertainties and other
factors carefully in evaluating the forward-looking statements contained
in this release. As a result of these matters, changes in facts,
assumptions not being realized or other circumstances, CSI's actual
results may differ materially from the expected results discussed in the
forward-looking statements contained in this release. The
forward-looking statements made in this release are made only as of the
date of this release, and CSI undertakes no obligation to update them to
reflect subsequent events or circumstances.
Micro Crown OAS CSI has commenced its COAST Investigational
Device Exemption clinical trial to evaluate the safety and effectiveness
of its new micro crown orbital technology in treating coronary arteries. This
new system is limited by federal law to investigational use and is
currently not commercially available in the United States or Japan.
View source version on businesswire.com: http://www.businesswire.com/news/home/20150713006212/en/
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