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, today, along with OrbusNeich Medical
Company Ltd (OrbusNeich®), announced FDA PMA approval of
OrbusNeich’s Scoreflex® NC Scoring Percutaneous Transluminal
Coronary Angioplasty (PTCA) Catheter (Scoreflex NC).
Scoreflex NC is a focused force PTCA scoring balloon with a
dual-wire system which creates a focal stress pattern to facilitate
safe and controlled plaque modification at lower resolution
pressure. Scoreflex NC is indicated for the dilatation of a de novo
stenotic portion of a coronary artery and in-stent restenosis in
patients evidencing coronary ischemia for the purpose of improving
myocardial perfusion.
A pivotal clinical study was performed in the U.S. in twelve
investigational sites, with 200 patients being treated. The results
of the Scoreflex NC - Scoring PTCA Catheter Clinical Study support
the acute safety and device success of the Scoreflex NC - Scoring
PTCA Catheter and its intended use as a dilatation catheter in the
stenotic portion of a coronary artery stenosis (≥70% diameter
stenosis).
Dr. David Kandzari, Chief of the Piedmont Heart Institute and
Cardiovascular Service Line; Director, Interventional Cardiology of
the Piedmont Heart Institute; and Chief Scientific Officer for
Piedmont Healthcare in Atlanta, Ga., and Principal Investigator of
the study, said, “The pivotal study demonstrated the effectiveness
of Scoreflex NC to safely modify stenotic coronary arteries,
demonstrating excellent deliverability, luminal gain, and a high
rate of procedural success. Scoreflex NC will be a welcomed
addition to the interventional toolbox to treat complex coronary
artery disease.”
“We are extremely pleased to receive FDA PMA approval for our
Scoreflex NC device and are delighted to introduce this scoring
balloon to U.S. physicians through our distribution partner, CSI,”
said David Chien, OrbusNeich’s Chairman and CEO. “In our continued
commitment to delivering innovative products that can change the
lives of many patients, we are confident our product will provide
increased treatment options.”
Scott Ward, CSI’s Chairman, President and Chief Executive
Officer, said, “We remain committed to expanding our portfolio of
differentiated products that help physicians deliver improved
outcomes for patients with complex coronary artery disease.
Scoreflex NC complements our coronary orbital atherectomy system
and expands the patient population we serve.”
About Scoreflex NC – Scoring PTCA Catheter Pivotal Clinical
Study
A prospective, open label, multi-center, single arm,
observational study designed to evaluate the acute safety and
device procedural success of the Scoreflex NC Scoring PTCA
catheters in subjects with stenotic coronary arteries during
percutaneous coronary intervention.
Two-hundred subjects were treated at 12 U.S. sites with the
Scoreflex NC Scoring PTCA catheter during their index
procedure.
ClinicalTrials.gov Identifier: NCT03763747
About Coronary Artery Disease (CAD)
CAD is a life-threatening condition and a leading cause of death
in men and women globally. CAD occurs when a fatty material called
plaque builds up on the walls of arteries that supply blood to the
heart. The plaque buildup causes the arteries to harden and narrow
(atherosclerosis), reducing blood flow. The risk of CAD increases
if a person has one or more of the following: high blood pressure,
abnormal cholesterol levels, diabetes, or family history of early
heart disease. According to the Centers for Disease Control and
Prevention, 18 million people in the United States have CAD, the
most common form of heart disease. Heart disease claims more than
650,000 lives in the United States each year. According to
estimates, significant arterial calcium is present in about 38
percent of patients undergoing a PCI. Significant calcium
contributes to poor stent delivery, expansion and wall apposition
leading to poor outcomes and higher treatment costs in coronary
interventions when traditional therapies are used, including a
significantly higher occurrence of death and major adverse cardiac
events (MACE).
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 system treats calcified and
fibrotic plaque in arterial vessels throughout the leg and heart
and addresses many of the limitations associated with existing
surgical, catheter and pharmacological treatment alternatives. For
additional information, please visit www.csi360.com and connect on
Twitter @csi360.
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 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
commercial launch of Scoreflex NC in the U.S.; the benefits of
Scoreflex NC, including the potential expansion of the patient
population that CSI serves; and CSI’s commitment to expand its
portfolio of products, 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, including
Scoreflex NC; the reluctance of physicians, hospitals and other
organizations to accept new products; the impact of competitive
products and pricing; 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.
About OrbusNeich
OrbusNeich is a global pioneer in the provision of life-changing
vascular solutions and offers an extensive portfolio of products
that set industry benchmarks in vascular intervention. Current
products include the world's first dual therapy stents, the COMBO®
Plus and COMBO® Dual Therapy Stents, together with stents and
balloons marketed under the names of Azule®, Scoreflex®, Scoreflex®
NC, Sapphire® II, Sapphire® II PRO, Sapphire® 3, Sapphire® II NC
Sapphire® NC24, Sapphire® NC Plus, Teleport® and Teleport® Control,
as well as products to treat peripheral artery disease: the Jade®
and Scoreflex® PTA balloons. OrbusNeich is headquartered in Hong
Kong and has operations in Shenzhen, China; Fort Lauderdale,
Florida, USA; Hoevelaken, The Netherlands; Zuchwil, Switzerland;
and regional sales offices in Germany, France, Switzerland, Spain,
Japan, Hong Kong, Singapore, China and Malaysia. OrbusNeich
supplies medical devices to physicians in more than 60 countries.
For more information, visit www.OrbusNeich.com.
Scoreflex® NC Scoring PTCA Catheter
INDICATIONS: The Scoreflex NC Scoring PTCA Catheter is
indicated for: Balloon dilatation of a de novo stenotic portion of
a coronary artery and in-stent restenosis in coronary arteries in
patients evidencing coronary ischemia for the purpose of improving
myocardial perfusion.
CONTRAINDICATIONS: The use of the Scoreflex NC Scoring PTCA
Catheter is contraindicated in the following patient types:
Patients with an unprotected left main coronary artery. Patients
with coronary artery spasm in the absence of a significant
stenosis.
WARNINGS: When using this type of device, the following
warnings should be observed: This device is intended for single
use only. Do not resterilize and/or reuse, as this can potentially
result in compromised device performance and increased risk of
cross-contamination. This balloon is not intended for the
expansion or delivery of a stent. PTCA in patients who are not
acceptable candidates for coronary artery bypass graft surgery
require careful consideration, including possible hemodynamic
support during PTCA, as treatment of this patient population
carries special risk. To reduce the potential for vessel damage,
the inflated diameter of the balloon should approximate the
diameter of the vessel just proximal and distal to the
stenosis.When the catheter is exposed to the vascular system, it
should be manipulated while under high-quality fluoroscopic
observation. Do not advance or retract the catheter unless the
balloon is fully deflated under vacuum. If resistance is met during
manipulation, determine the cause of the resistance before
proceeding. Applying excessive force to the catheter can result in
tip or catheter breakage, catheter kink, or balloon separation. Do
not twist the catheter shaft in excess of 180 degrees when the tip
is constrained. Balloon pressure should not exceed the rated burst
pressure (RBP) indicated on the package. The rated burst pressure
is based on the results of in vitro testing. At least 99.9 percent
of the balloons, (with a 95 percent confidence) will not burst at
or below their rated burst pressure. Use of a pressure monitoring
device is recommended to prevent over pressurization.To reduce the
potential for air embolus into the vessel, use only the recommended
balloon inflation medium. Never use air or any gaseous medium to
inflate the balloon. Do not re-straighten a kinked hypotube;
straightening a kinked metal shaft may result in breakage of the
shaft. PTCA should only be performed at hospitals where emergency
coronary artery bypass graft surgery can be quickly performed in
the event of a potentially injurious or life-threatening
complication.
PRECAUTIONS: Use the catheter prior to the “Use By” date
specified on the package. Prior to angioplasty, the catheter
should be examined to verify functionality and ensure that its size
and shape are suitable for the specific procedure for which it is
to be used.The catheter system should be used only by physicians
trained in percutaneous transluminal coronary angioplasty. During
the procedure, appropriate anticoagulant and coronary vasodilator
therapy must be provided to the patient as needed. After the
procedure, anticoagulant therapy should be continued for a period
of time as determined by the physician. Never advance the
Scoreflex NC Scoring PTCA Catheter without the guidewire extending
from the tip. Do not use oil-based contrast medium, organic
solvents, or alcohols; there is a possibility of catheter leak,
damage, or lubrication loss. The balloon deflation time has been
established as 15 seconds based on in vitro bench testing results.
Do not reinsert the PTCA catheter into the coil dispenser after
procedural use. Discard all disposable devices used during this
procedure per local requirements for medical device waste
disposal.
CAUTION: Federal law (USA) restricts this device to the sale by
or on the order of a physician.
See the instructions for use before performing Scoreflex NC
Scoring PTCA Catheter procedures for detailed information regarding
the procedure, indications, contraindications, warnings,
precautions, and potential adverse events.
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version on businesswire.com: https://www.businesswire.com/news/home/20220120005003/en/
Cardiovascular Systems, Inc. Jack Nielsen Vice President,
Investor Relations & Corporate Communications (651) 202-4919
j.nielsen@csi360.com 1225 Old Highway 8 NW St. Paul, MN 55112
www.csi360.com
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