ST. PAUL, Minn.--(BUSINESS WIRE)--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 Benefits
As 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 Availability
The 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 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 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 Products
The 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.