Cardiovascular Systems, Inc. Announces First Patient Enrolled in REACH PVI Clinical Study
June 11 2019 - 5:00PM
Business Wire
Trial to Study Treatment of Peripheral
Artery Disease with Orbital Atherectomy via Radial Access
Cardiovascular Systems, Inc. (CSI®) (NASDAQ: CSII), a medical
device company developing and commercializing innovative
interventional treatment systems for patients with peripheral and
coronary artery disease, announced today the first patient was
enrolled in the REACH PVI study. The purpose of this study is to
prospectively evaluate acute clinical outcomes of orbital
atherectomy via transradial access for the treatment of peripheral
artery disease (PAD) in lower extremity lesions.
CSI’s low profile, 5Fr, Extended Length Diamondback 360®
Peripheral Orbital Atherectomy System (OAS) and Extended Length
Stealth 360® Peripheral OAS are the only atherectomy devices that
allow radial access for the treatment of peripheral lesions.
National Primary Investigator for REACH PVI, Dr. Ankur Lodha,
MD, Interventional Cardiologist, Cardiovascular Institute of the
South, Lafayette, La., enrolled the first patient.
Dr. Lodha said, “When endovascular intervention is necessary,
PAD lesions are mostly treated through femoral artery access.
However, many PAD patients could benefit from faster ambulation
time post procedure that radial artery access offers. In addition,
some patients may have comorbidities, such as obesity, that
complicate or preclude femoral access.”
Dr. Lodha continued, “The benefits of radial access for
percutaneous peripheral vascular interventions are well documented.
We believe this study will demonstrate that many of these known
benefits, such as low complication rates, high cost effectiveness,
and short time to ambulation, can be achieved using orbital
atherectomy to treat lower limb PAD lesions through radial
access.”
Scott Ward, CSI Chairman, President, and Chief Executive
Officer, said, “CSI continues to innovate and develop medical
evidence to improve the care of patients suffering from PAD. The
commercialization of the Extended Length orbital atherectomy
systems and our investment in REACH PVI both demonstrate our
commitment to physicians and the patients they serve.”
About REACH PVIREACH PVI is a prospective, observational,
single-arm, multi-center post-market study that will enroll 50
patients at up to 10 sites across the United States. The purpose of
this study is to prospectively evaluate acute clinical outcomes of
orbital atherectomy via transradial access for treatment of
peripheral artery disease (PAD) in lower extremity lesions. The
study will include CSI orbital atherectomy devices FDA-cleared for
treatment of PAD. All subjects will be followed post-procedure
through the first standard of care follow-up visit (7-45 days
post-procedure).
More information about the study design is available at
www.ClinicalTrials.gov; identifier: NCT03943160.
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
OAS 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.
Over 450,000 of CSI’s devices have been sold to leading
institutions worldwide.
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 benefits of the Extended Length Peripheral Orbital
Atherectomy Systems and the REACH PVI study, including the
anticipated number of patients and sites in and the benefits of
such study, are forward-looking statements. These statements
involve risks and uncertainties that could cause results to differ
materially from those projected, including, but not limited to, the
experience of physicians regarding the effectiveness and
reliability of products sold by CSI; the potential for
unanticipated delays in enrolling medical centers and patients for
the REACH PVI study; actual clinical study results; 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.
Product Disclosure:
Peripheral ProductsThe 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. See the instructions for use for detailed
information regarding the procedure, indications,
contraindications, warnings, precautions, and potential adverse
events. For further information call CSI at 1-877-274-0901 and/or
consult CSI’s website at www.csi360.com.
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version on businesswire.com: https://www.businesswire.com/news/home/20190611005836/en/
Cardiovascular Systems, Inc.Jack Nielsen(651)
202-4919j.nielsen@csi360.com
Padilla:Matt Sullivan(612)
455-1709matt.sullivan@padillaco.com
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