Cardiovascular Systems Announces First Patient Enrolled in COMPLIANCE 360° Clinical Trial
July 13 2009 - 4:00PM
Business Wire
Cardiovascular Systems, Inc. (CSI) (Nasdaq: CSII), a medical
device company developing and commercializing innovative
interventional treatment systems for vascular disease, announced
today that the first patient has been enrolled in the COMPLIANCE
360� clinical trial. This prospective, randomized study will
generate additional data on patient outcomes achieved in treating
lesions above the knee with CSI�s Diamondback 360�� Peripheral
Arterial System, a minimally invasive catheter for treating
peripheral arterial disease (PAD).
COMPLIANCE 360� will compare the benefits of first modifying
calcified plaque with the Diamondback 360� system followed by
low-pressure balloon inflation if needed, versus the use of
high-pressure balloon angioplasty alone in calcified lesions above
the knee. Treatment with only high-pressure balloon angioplasty
often damages large diseased vessels above the knee. Initial
treatment with the Diamondback 360� could reduce the level of
balloon pressure required to finish opening the vessel. The
COMPLIANCE 360� study calls for enrolling 50 patients at five U.S.
medical centers. Patients will be followed for 12 months, and an
independent angiography core lab will verify results.
�CSI is devoted to clinical research that leads to innovative
solutions to conquer PAD and keep patients walking without pain,�
said David L. Martin, CSI president and chief executive officer.
�The physical, emotional and financial toll of more than 100,000
amputations annually in the United States is unacceptable. Our tool
in doctors� hands has successfully treated more than 15,000
patients in less than two years since our FDA clearance. We are
confident that the Diamondback 360� offers an effective solution to
address PAD, giving patients and their loved ones new hope.
COMPLIANCE 360� is the first of several post-market studies CSI is
sponsoring to provide physicians with the clinical data they need.
We plan to launch CALCIUM 360�, a study evaluating treatment with
the Diamondback 360� in calcified lesions below the knee, in the
coming months.�
CSI received FDA 510(k) marketing clearance for the Diamondback
360� as a PAD therapy in August 2007 on the basis of data from the
OASIS study, a prospective study which enrolled 124 patients at 20
medical centers. Since then, nearly 500 hospitals have adopted the
Diamondback 360� system.
Dr. Ravish Sachar, an interventional cardiologist at WakeMed
Health and Hospital in Raleigh, N.C., who enrolled the first
patient in the COMPLIANCE 360� trial, commented, �The Diamondback
360� represents a viable treatment option for patients who
previously have had limited options. Treating this disease can be
very challenging due to the frequency of non-compliant, calcified
plaque resulting from diabetes, smoking or renal failure. It has
long been understood that high-pressure balloon angioplasty alone
in these types of lesions can lead to vessel damage, and this study
will help provide insight into the benefits of plaque modification
prior to angioplasty.�
Dr. Ray Dattilo, COMPLIANCE 360� principal investigator and
director of peripheral interventions at St. Francis Hospital,
Topeka, Kan., added, �In this difficult healthcare environment,
with increasing costs and not enough dollars to go around, it is
especially important to demonstrate that a new technology is better
than the current standard of care. CSI understands that spending
scarce healthcare dollars wisely is a necessity, and the company is
willing to devote resources to a randomized trial. The Diamondback
system, supported by sound clinical data, could create a paradigm
shift in the treatment of PAD.�
About Cardiovascular Systems, Inc.
Cardiovascular Systems, Inc. is a medical device company focused
on developing and commercializing interventional treatment systems
for vascular disease. Between 8 and 12 million Americans suffer
from peripheral arterial disease (PAD), which is caused by the
accumulation of plaque in leg or foot arteries, reducing blood flow
and leading to leg pain, and eventually tissue loss and amputation.
The company�s Diamondback 360� Peripheral Arterial System is
capable of treating a broad range of plaque types both above and
below the knee, and addresses many of the limitations associated
with existing treatment alternatives. In August 2007, the U.S. FDA
granted 510(k) clearance for the use of the Diamondback 360� as a
therapy for PAD (peripheral arterial disease), and CSI commenced a
U.S. product launch in September 2007. The company provides a
comprehensive system for treating PAD through its Viper line of
supplemental products and by offering Invatec balloon catheters.
The Diamondback 360� system has been adopted by nearly 500
hospitals across the United States. For more information visit the
company�s Web site 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 intended to enjoy the protection of the
safe harbor for forward-looking statements provided by that Act.
For example, statements in this press release regarding (i) the
data to be generated by the COMPLIANCE 360� study; (ii) the
anticipated benefits of initial treatment with the Diamondback
360�; (iii) the number of patients to be enrolled and expected
follow up; and (iv) our plans to launch the CALCIUM 360� study, are
forward looking statements. These statements involve risks and
uncertainties which could cause results to differ materially from
those projected, including but not limited to the potential for
unanticipated delays in enrolling medical centers and patients for
studies; new data or events that may disrupt plans for these
studies; and other factors detailed from time to time in CSI�s SEC
reports, including its registration statement on Form S-4 declared
effective by the SEC on January 26, 2009. 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.
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