Study Evaluates Clinical Benefits of Treating Peripheral Arterial
Disease
Behind and Below the Knee with Diamondback 360(R) System
ST. PAUL, Minn., Apr 29, 2010 (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(R)
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(R) 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(R) 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.
SOURCE: Cardiovascular Systems, Inc.
Padilla Speer Beardsley:
Marian Briggs, 612-455-1742
mbriggs@psbpr.com
or
Nancy A. Johnson, 612-455-1745
njohnson@psbpr.com
or
For Cardiovascular Systems, Inc.
Investor Relations, 651-259-2800
investorrelations@csi360.com