Cardiovascular Systems, Inc. (CSI) (NASDAQ:CSII), today
announced that CBSET, a not-for-profit preclinical research
institute dedicated to biomedical research, education, and
advancement of medical technologies, disclosed that modification of
atherosclerotic plaque with CSI’s Diamondback 360® orbital
atherectomy device improved paclitaxel absorption by 50 percent in
calcified cadavaric peripheral arteries. Historically, plaque
barriers in arteries have been reported to make drug diffusion and
retention more difficult.
Results from this ongoing preclinical study were presented by
Elazer Edelman, M.D., Ph.D., Chairman and co-founder of CBSET, on
Sunday, February 22, 2015, in a dedicated session on New Strategies
for the Treatment of Calcified Lesions at the 2015 Cardiovascular
Research Technologies (CRT) conference in Washington, D.C.
Said Dr. Edelman, “This study presents important mechanistic
findings that may contribute to the expansion of endovascular
intervention for PAD treatment in femoropopliteal and tibioperoneal
vessels. It has been hypothesized that drug transfer by DCB is
impeded by the mature plaque morphology and may be improved by
primary lesion treatment with orbital atherectomy. The results of
our study demonstrated that benign lesion modification with CSI’s
orbital atherectomy device improved paclitaxel delivery in human
cadaver peripheral arteries with substantial calcified plaque
burdens.”
David L. Martin, President and Chief Executive Officer of
Cardiovascular Systems, Inc., said, “We are encouraged by the
continued study of CSI’s unique orbital atherectomy mechanism of
action and how it can help facilitate improved drug absorption and
patient outcomes when calcium is present.”
About Peripheral Artery Disease
As many as 18 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
Peripheral Orbital Atherectomy Systems, 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.
About CBSET
CBSET — Concord Biomedical Sciences & Emerging Technologies
— is the preclinical research leader in critically important
therapeutic fields such as interventional cardiology, renal disease
and dialysis, chronic drug-resistant hypertension, women’s health,
minimally invasive surgery, orthopedics, biological and synthetic
tissue repair, drug delivery, bioresorbable devices, and
combination medical device and drug-eluting products. CBSET
occupies a 35,000-square-foot, state-of-the-art facility near
Boston that includes a vivarium, catheterization/imaging labs,
surgical suites, dedicated labs for SEM, histopathology/pathology,
and drug metabolism and pharmacokinetics. CBSET offers the latest
equipment for fluoroscopy, echocardiography (TEE/TTE),
electrophysiology, IVUS, optical coherence tomography (OCT),
endoscopy/laparoscopy, surgical video recording, histology,
microradiography, and SEM (Scanning Electron Microscopy).
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 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. To date, nearly 182,000 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.
Product Disclosures
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.
Contraindications: The OAS is contraindicated when the
ViperWire guide wire cannot pass across the coronary lesion or the
target lesion is within a bypass graft or stent. The OAS is
contraindicated when the patient is not an appropriate candidate
for bypass surgery, angioplasty, or atherectomy therapy, or has
angiographic evidence of thrombus, or has only one open vessel, or
has angiographic evidence of significant dissection at the
treatment site and for women who are pregnant or children.
Warnings/Precautions: Performing treatment in excessively
tortuous vessels or bifurcations may result in vessel damage; The
OAS was only evaluated in severely calcified lesions, A temporary
pacing lead may be necessary when treating lesions in the right
coronary and circumflex arteries; On-site surgical back-up should
be included as a clinical consideration; Use in patients with an
ejection fraction (EF) of less than 25% has not been evaluated. See
the instructions for use before performing Diamondback 360 Coronary
OAS procedures 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.
Caution: Federal law (USA) restricts this device to sale
by or on the order of a physician.
Cardiovascular Systems, Inc.Jack Nielsen,
651-202-4919j.nielsen@csi360.comorPadillaCRTMatt Sullivan,
612-455-1709matt.sullivan@padillacrt.com
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