Device provides alternative access point to
treat patients suffering from peripheral artery disease
Cardiovascular Systems, Inc. (CSI®) (NASDAQ: CSII), a medical
device company developing and commercializing innovative
interventional treatment systems for peripheral and coronary artery
disease, announced today that the first patients were treated using
its FDA-cleared extended length Diamondback 360® Peripheral Orbital
Atherectomy Device (OAD) to treat peripheral artery disease (PAD).
Dr. Mahir Elder, an interventional cardiologist at the Detroit
Medical Center Heart Hospital, and Drs. Ian Cawich and Vasili
Lendel, both interventional cardiologists at Arkansas Heart
Hospital, treated patients using the new device.
Dr. Cawich noted, “From a physician’s perspective, radial access
is a viable alternative that allows us to minimize bleeding and
avoid commonly diseased femoral arteries. Additionally, it allows
for both bilateral diagnostics and interventions while also
eliminating the need for femoral closure devices. The result for
patients is a far less invasive procedure.”
Scott Ward, CSI Chairman, President, and Chief Executive
Officer, said “The first procedures using the extended length
Diamondback 360 OAD is a milestone for physicians, patients, and
our company. When surgery is necessary, PAD lesions can be treated
through femoral artery access. However, factors such as obesity,
the presence of vascular disease and scar tissue can complicate
femoral access. Radial access allows physicians to reach and treat
lower limb PAD lesions through the radial artery in the wrist,
providing an alternative access point and more options to treat
complicated and at-risk patients.”
Dr. Lendel added, “Radial access has been on the rise for
percutaneous coronary interventions for several years, and the
benefits have been well documented. Now, I’m excited that new
devices like CSI’s Extended Length OAS are enabling me to bring the
benefits of radial access to another patient population in those
undergoing peripheral vascular interventions.”
Patient and Physician BenefitsAs an alternative to
femoral access, the extended length Diamondback 360 OAD reduces
invasiveness, and often results in greater patient satisfaction. In
addition, patients experience:
- Fewer access site bleeding
complications;
- The ability to walk less than an hour
post-procedure; and
- Shorter hospital stays, on
average.
Said Dr. Elder, “As an interventional cardiologist, I value the
ability to treat my PAD patients with this device. Treating PAD via
radial access enables me to provide a better patient experience
that includes faster ambulation and discharge than treating via
femoral access.”
Radial Access Diamondback 360 OAD AvailabilityThe radial
access Diamondback 360 OAD, currently available via a limited
market rollout, features a 5 Fr profile and three crown sizes:
- 1.25 diameter solid, 200 cm length
- 1.50 diameter solid, 200 cm length
- 1.75 diameter solid, 180 cm length
CSI anticipates a full commercial launch of the device in its
fiscal year 2019.
Concluded Ward, “CSI is committed to innovation and cultivating
less invasive access sites for percutaneous interventions. Our
extended length Diamondback 360 OAD demonstrates that commitment
and reflects the hard work of our team on behalf of patients and
physicians.”
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 the first 510(k) clearance for the use of the
Orbital Atherectomy System in peripheral arteries in August 2007.
In October 2013, the company received FDA approval for the Coronary
Orbital Atherectomy System. To date, over 356,000 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 benefits of the extended length Diamondback 360 OAD
and the full commercial launch thereof, including the anticipated
timing of such launch, 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
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 Peripheral Artery Disease (PAD)As many as 18
million Americans, most over age 65, suffer from PAD, which is
caused by the accumulation of plaque in peripheral arteries
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 is growing at double-digit rates. Literature shows that Balloon
angioplasty and stents can have significant shortcomings in
treating hard, calcified lesions. Stents are prone to fractures and
high recurrence rates, and treatment of hard, calcified lesions
often leads to vessel damage and suboptimal results. Millions of
patients with PAD may benefit from treatment with orbital
atherectomy utilizing the Diamondback 360® and Stealth
360® Peripheral Orbital Atherectomy Systems, which are
minimally invasive catheter systems developed and manufactured by
CSI. These 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.
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: http://www.businesswire.com/news/home/20180214005314/en/
Cardiovascular Systems, Inc.Jack Nielsen,
651-202-4919j.nielsen@csi360.comorPadillaMatt Sullivan,
612-455-1709matt.sullivan@padillaco.com
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