Cardiovascular Systems Completes Enrollment In CALCIUM 360° Clinical Trial
April 29 2010 - 4:05PM
Business Wire
Cardiovascular Systems, Inc. (CSI) (Nasdaq: CSII), has completed
patient enrollment in its prospective, randomized CALCIUM 360°
clinical trial, part of the company’s 360° Clinical Series. The
CALCIUM 360° feasibility study is evaluating the treatment of
peripheral arterial disease (PAD) behind and below the knee using
CSI’s Diamondback 360® System, a minimally invasive catheter for
treating PAD anywhere in the leg. Dr. Nicolas Shammas, an
interventional cardiologist at Trinity Medical Center, Bettendorf,
Iowa, is the study’s principal investigator.
“Reaching full enrollment is a significant step in the CALCIUM
360° trial, one of several studies completed or in progress, that
reflect our commitment to providing clinically useful data to
patients, their families and their physicians,” said David L.
Martin, president and CEO of Cardiovascular Systems. “There is a
strong need for safer, more effective and durable treatment options
for treating hardened plaque behind and below the knee.”
The CALCIUM 360° trial is comparing the effectiveness of the
Diamondback 360° to balloon angioplasty in treating atherosclerosis
in the smaller vessels behind and below the knee (popliteal, tibial
and peroneal). The study enrolled 50 patients at eight
investigational sites and is following patients for 12 months.
Interventional cardiologists and vascular surgeons are
participating in the study. The primary endpoint is 30 percent or
less residual stenosis, or plaque remaining, with no major
dissection. In addition to collecting clinical outcomes, the
CALCIUM 360° study will gauge the economic utility of both the
Diamondback 360° and angioplasty procedures and subsequent
hospitalizations.
“As the first randomized study in this field, CALCIUM 360° will
provide useful, clinically significant data on the treatment of
below-the-knee lesions,” said Dr. Jihad Mustapha, an interventional
cardiologist at Metro Health Hospital, Grand Rapids, Michigan, who
enrolled the most patients in this trial. “Patients with multiple
below-the-knee occlusions have traditionally had little hope of
salvaging a limb. I have used the Diamondback 360° to modify plaque
and restore blood flow in many patients who had been scheduled for
amputation.”
CALCIUM 360° is part of CSI’s 360° Clinical Series to
demonstrate successful acute outcomes and durable long-term results
with the Diamondback 360° System. The COMPLIANCE 360° feasibility
study, currently under way, is another study in the series that is
prospectively evaluating 50 patients treated with either the
Diamondback 360° or angioplasty in above-the-knee arteries. These
studies complement the already completed OASIS and OASIS Long Term
studies that demonstrated the safety, effectiveness and durability
of the Diamondback 360° device in treating peripheral vascular
disease.
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, the statements in this press release regarding CSI’s
expectation that the CALCIUM 360° study will provide useful,
clinically significant data on the treatment of below-the-knee
lesions is a forward-looking statement. 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 the study; new data or events that may disrupt plans
for this study; unexpected results or clinical outcomes in the
CALCIUM 360° study and other factors detailed from time to time in
CSI’s SEC reports, including its most recent annual report on Form
10-K. 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.
About Cardiovascular Systems, Inc.
Cardiovascular Systems, Inc., (CSI) (Nasdaq: CSII) based in St.
Paul, Minn., is a medical device company focused on providing
clinically proven, safe and effective interventional solutions for
vascular disease. The company’s Diamondback 360® System removes
calcified and fibrotic plaque in small and large peripheral
vessels, and addresses many of the limitations associated with
existing surgical, catheter and pharmacological 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. Since then, more than 25,000 procedures
have been performed using the system. For more information visit
the company’s website at www.csi360.com.
Product Disclosure
The Diamondback 360® System is a percutaneous orbital
atherectomy system indicated for use as therapy in patients with
occlusive atherosclerotic disease in peripheral arteries and
stenotic material from artificial arteriovenous dialysis fistulae.
The system is contraindicated for use in coronary arteries, bypass
grafts, stents or where thrombus or dissections are present.
Although the incidence of adverse events is rare, potential events
that can occur with atherectomy include: pain, hypotension,
CVA/TIA, death, dissection, perforation, distal embolization,
thrombus formation, hematuria, abrupt or acute vessel closure, or
arterial spasm.
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