Cardiovascular Systems, Inc. (NASDAQ: CSII) (CSI), today announced the
first use of its Diamondback 360® 60cm Peripheral Orbital
Atherectomy Systems (OAS) for the treatment of peripheral arterial
disease (PAD). Jihad A. Mustapha, M.D., FACC, FSCAI, Director of Heart
and Vascular at Metro Health Hospital in Wyoming, Mich., performed the
procedure through Tibiopedal access using the new, low-profile device.
Jihad A. Mustapha, M.D., FACC, FSCAI, Director of Heart and Vascular at Metro Health Hospital in Wyoming, Mich., is the first physician in the world to use Cardiovascular Systems' new 60cm Diamondback 360(R) Peripheral Orbital Atherectomy System to treat peripheral arterial disease (PAD). (Photo: Business Wire)
"CSI's new 60cm, 4 French devices provide physicians with broader
treatment options for challenging lesions in the lower leg," said David
L. Martin, CSI president and chief executive officer. "If left
untreated, these cases may result in lower limb amputation. Our new 60cm
Diamondback devices use smaller sheaths, which have been shown to reduce
procedure times and decrease complications from bleeding, enabling
quicker patient recovery."
CSI's Diamondback 360 Peripheral OAS allows physicians to gain access
through the foot or ankle to treat PAD in the small vessels located
below the knee due to its very small profile and short length. The
recently approved Diamondback 360 60cm Peripheral OAS devices are
available in two crown designs, the 1.25mm Micro Crown, and the 1.25mm
Solid Crown. Each crown offers a shorter shaft length and a smaller more
flexible shaft than their predecessors for improved ease of use.
Said Dr. Mustapha, "Many of the patients we treat have advanced PAD and
suffer from Critical Limb Ischemia, or CLI. These patients often have
complex, calcified lesions in their lower leg which are challenging to
access and treat using the traditional femoral artery access site. CSI's
new orbital atherectomy system now allows us more options to treat those
lesions by providing a low-profile system that is fully compatible with
alternative access sites in the foot or ankle. Having a variety of
treatment options allows us to treat a broader range of patients who may
otherwise be facing amputation."
The Diamondback 360 Peripheral OAS uses a patented combination of
differential sanding and centrifugal force to reduce arterial plaque,
including calcium, which can cause complications when treating PAD.
Calcium is present in about 65 percent of the 2.5 million people
diagnosed annually with PAD and leads to poor outcomes and higher
treatment costs when traditional balloon and stent therapies are
used-including dissection, vessel wall trauma and stent fracture.
For more information n the Diamondback 360 Peripheral OAS, contact Cardiovascular
About Jihad A. Mustapha, M.D., FACC, FSCAIDr. Mustapha is a
board-certified interventional cardiologist. He specializes in minimally
invasive, non-surgical therapy for heart and peripheral vascular
disease. He has advanced training in coronary stent and complex
peripheral vascular disease treatments including laser, atherectomy, and
totally occluded arteries. Dr. Mustapha graduated from Wayne State
University and St. George University School of Medicine. He completed
Fellowships in both Cardiology and Interventional Cardiology at
Louisiana State University School of Medicine.
Dr. Mustapha is currently in practice at Metro Health Hospital - Metro
Heart and Vascular in Wyoming, Michigan, where he is the Director of
Cardiovascular Catheterization Laboratories, Director of Endovascular
Interventions and Director of Cardiovascular Research. He is a Clinical
Assistant Professor at Michigan State University - COM (E. Lansing,
MI). Dr. Mustapha is the Founder and Director of the
Amputation Prevention Symposium (AMP). He has multiple publications,
including those on critical limb ischemia and amputation prevention.
About Peripheral Arterial DiseaseMore than 12 million
Americans, most over age 65, suffer from PAD, which is caused by the
accumulation of plaque 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 is
growing at double-digit rates.
Millions of patients with PAD may benefit from treatment with orbital
atherectomy utilizing the Stealth 360 and Diamondback 360, 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. 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 often leads to vessel damage and suboptimal results.
Product DisclosureThe Diamondback 360®
Peripheral Orbital Atherectomy Systems 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 peripheral
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.
About Metro HealthAn award-winning leader in community
healthcare, Metro Health serves more than 250,000 patients annually from
across West Michigan - and beyond. In addition to its 208-bed hospital,
which provides a comprehensive suite of inpatient and outpatient
healthcare services, Metro Health has a growing number neighborhood
outpatient centers and offices throughout West Michigan, as well as a
community clinic for the underserved and student health clinics at Grand
Valley State University and Aquinas College. With more than 500
physicians on staff, Metro Health provides a growing number of specialty
health services, including cancer treatment, heart and vascular,
neurology, pulmonology and others. Many are members of the Metro Health
Medical Group. The hospital is committed to promoting health and
wellness through the work of the Metro Health Hospital Foundation, Live
Healthy community outreach classes and educational programs and more.
Visit us www.metrohealth.net,
follow us on Twitter @MetroHealthGr and like us on Facebook/MetroHealth.
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
August 2007. To date, over 135,000 of CSI's devices have been sold to
leading institutions across the United States. In October 2013, the
company received FDA approval for the use of the Diamondback Orbital
Atherectomy System in coronary arteries. For more information, visit the
company's website at www.csi360.com.
Photos/Multimedia Gallery Available: http://www.businesswire.com/multimedia/home/20140312005872/en/
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