Cardiovascular Systems Enrolls First Patients in OPTIMIZE Study
October 29 2015 - 7:00AM
Business Wire
- Study to assess acute and long-term
clinical results of peripheral orbital atherectomy with adjunctive
drug-coated balloon angioplasty versus drug-coated balloon
angioplasty alone
- European peripheral trial will enroll
up to 50 patients at 10 potential sites
Cardiovascular Systems, Inc. (CSI) (NASDAQ:CSII), announced that
the first two patients have been enrolled in its OPTIMIZE,
peripheral Orbital Atherectomy System (OAS) study. Taking place in
Europe, OPTIMIZE will evaluate the acute and long-term clinical
outcomes of orbital atherectomy with adjunctive drug-coated balloon
(DCB) angioplasty versus DCB angioplasty alone for treatment of
Peripheral Artery Disease (PAD). Specifically, the study will look
at patients with calcified below the knee (BTK) lesions. OPTIMIZE
also will compare the economic outcomes between the patient groups.
Professor Marianne Brodmann, MD, Director of the Division of
Angiology, Medical University of Graz, Austria, performed the first
procedure on October 28 together with Hannes Deutschmann, Director
of the Vascular and Interventional Department of Radiology, Medical
University of Graz, Austria and Dr. Franz Hafner.
“We are excited to spearhead the study of CSI’s orbital
atherectomy technology in Europe,” said Dr. Brodmann. “Below the
knee PAD is associated with a higher prevalence of calcium than
above the knee PAD. We look forward to evaluating the potential
outcome benefit of using CSI’s orbital atherectomy system to remove
calcified plaque prior to DCB angioplasty in this high-risk patient
population.”
OPTIMIZE is a prospective, randomized, multi-center, post-market
pilot study using CSI’s peripheral OAS to perform atherectomy
procedures in conjunction with drug coated balloons. Up to 50
subjects may be enrolled at up to 10 study sites throughout the
continent.
Millions of patients with PAD may benefit from treatment with
orbital atherectomy utilizing the peripheral OAS, minimally
invasive catheter systems developed and manufactured by CSI. The
orbital atherectomy systems use a diamond-coated crown, attached to
an orbiting shaft, which sands away plaque while preserving healthy
vessel tissue — a critical factor in preventing reoccurrences.
Balloon angioplasty and stents have significant shortcomings in
treating hard, calcified lesions. Stents are prone to fractures and
high recurrence rates, and treatment of hard, calcified lesions may
lead to vessel damage and suboptimal results.
“Studying the combination of orbital atherectomy and drug-coated
balloon angioplasty is an important step in our commitment to
minimizing the adverse consequences of PAD for the millions of
people afflicted with the disease,” said David L. Martin, CSI
president and chief executive officer. “Our goal is to show that
for calcified BTK arteries, pre-treatment with orbital atherectomy
followed with DCB, will provide incremental benefits versus DCB
angioplasty alone.”
The national principal investigators for OPTIMIZE are Dr.
Brodmann; Professor Gunnar Tepe, MD, Klinikum Rosenheim, Germany;
and Professor Thomas Zeller, MD, Herz-Zentrum Bad Krozingen,
Germany.
About Peripheral Arterial Disease (PAD)As many as 18
million Americans, most over age 65, suffer from PAD, which is
caused by plaque accumulation in peripheral arteries (commonly the
pelvis or leg) reducing blood flow. Symptoms include leg pain when
walking or at rest. Left untreated, PAD can lead to severe pain,
immobility, non-healing wounds and eventually limb amputation. With
risk factors such as diabetes and obesity on the rise, the
prevalence of PAD continues to grow.
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.
The Stealth 360® Peripheral Orbital Atherectomy System (OAS)
received CE Mark in October 2014. To date, over 220,000 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 HarborCertain 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, statements in this press release
regarding the OPTIMIZE trial, including the number of subjects
expected to be enrolled and the number of sites and the expected
outcomes of the trial,, 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 effectiveness of the peripheral OAS; actual
clinical trial and study results; government clearances and
approvals; and other factors detailed from time to time in CSI’s
SEC 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.
Peripheral Product DisclosuresThe Stealth 360® PAD System
and Diamondback 360® PAD System are percutaneous orbital
atherectomy systems indicated for use as therapy in patients with
occlusive atherosclerotic disease in peripheral arteries and
stenotic material from artificial arteriovenous dialysis fistulae.
The systems are 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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version on businesswire.com: http://www.businesswire.com/news/home/20151029005209/en/
Cardiovascular Systems, Inc.Jack Nielsen,
651-202-4919j.nielsen@csi360.comorPadillaCRTMatt Sullivan,
612-455-1709matt.sullivan@padillacrt.com
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