Cardiovascular Systems Enrolls First Patient in CALCIUM 360° Clinical Trial
November 19 2009 - 8:00AM
Business Wire
Cardiovascular Systems, Inc. (CSI) (Nasdaq:CSII), announces the
first patient enrollment in its prospective, randomized CALCIUM
360° clinical trial, part of the company’s 360° Clinical Series.
The CALCIUM 360° study will evaluate the treatment of peripheral
arterial disease (PAD) behind and below the knee using CSI’s
Diamondback 360® PAD System, a minimally invasive catheter for
treating PAD anywhere in the leg. The first procedure was performed
successfully by Dr. Nicolas Shammas at Trinity Medical Center,
Bettendorf, Iowa. Dr. Shammas is the research director of the
Midwest Cardiovascular Research Foundation in Iowa. He and Dr.
Russell Lam, Presbyterian Hospital, Dallas, are the study’s
co-principal investigators.
“Balloon angioplasty, the current standard of care for
endovascular treatment, may cause severe dissection, or cracking,
in vessels with hardened plaque, which in turn could require
placement of a stent,” said Dr. Shammas. “The Diamondback 360° may
offer physicians an essential solution for effectively removing
hardened plaque without a high rate of dissection and need for
stenting in below-the-knee lesions. CALCIUM 360° will build on
previous studies of the Diamondback 360° procedure, adding to our
understanding of this unique technology.”
The CALCIUM 360° trial will compare 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 will enroll 50 patients at five
investigational sites and follow patients for 12 months. The
primary endpoint is 30 percent or less residual stenosis, or plaque
remaining, with no major dissection. In this study, Volcano
Corporation’s intravascular ultrasound VH® IVUS system is being
used to acquire images which provide detailed, accurate
measurements of plaque and vessels.
“Plaque buildup in the smaller vessels behind and below the knee
is often calcified and difficult to treat with other devices and
procedures,” said Dr. Lam. “I am optimistic that data from the
CALCIUM 360° study will demonstrate that we can safely restore
blood flow, assist in improving wound healing, prevent amputations
and improve quality of life in patients treated with the
Diamondback 360°.”
CALCIUM 360° is the second study in CSI’s 360° Clinical Series,
which is designed to demonstrate successful acute outcomes and
durable long-term results with the Diamondback 360° PAD System. The
CALCIUM 360° study complements the COMPLIANCE 360° study, initiated
in June 2009, another prospective, randomized study of 50 patients
to evaluate use of the Diamondback 360° in above-the-knee
arteries.
David L. Martin, president and CEO of Cardiovascular Systems,
noted, “CSI is leading the way in collecting clinical data to
advance the standard of care for PAD patients, save limbs and
lives, and support evidence-based medicine. CALCIUM 360° focuses on
changing the compliance of hardened plaque below the knee, where
more effective, durable treatments are especially needed. Through
this and our other evaluations, we are also collecting economic
data to demonstrate the cost-effectiveness of the Diamondback 360°
procedure ─ a vital consideration in this cost-conscious healthcare
environment.”
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, the first-ever prospective study evaluating a plaque
removal system, which enrolled 124 patients at 20 sites. Acute
outcomes demonstrated that the Diamondback 360° device is safe and
effective. Six-month results showed no major amputations, and 97.5
percent of patients required no reintervention. Recently announced
follow up on 64 patients demonstrated the long-term durability of
treatment with the Diamondback 360°, with a 100-percent limb
salvage rate maintained and freedom from reintervention in 86.4
percent of patients after two years.
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 CALCIUM 360° study; (ii) the
anticipated benefits of initial treatment with the Diamondback
360°; and (iii) the number of patients to be enrolled and expected
follow up, 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 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 solutions for vascular
disease. The company’s Diamondback 360® PAD 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 600 hospitals
across the United States have adopted the system. For more
information visit the company’s Web site at www.csi360.com.
Product Disclosure
The Diamondback 360® PAD 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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