New Journal Article Highlights Mechanical Effects of Orbital Atherectomy & Rotational Atherectomy in Treating Heavily Calcifi...
May 19 2015 - 9:00AM
Business Wire
Study Finds Significant Tissue Modification
Associated with Orbital Atherectomy Led to Better Stent Apposition
and Expansion
Cardiovascular Systems, Inc. (CSI) (NASDAQ: CSII) today
announced that a new article e-published in May 2015 in The Journal
of Catheterization and Cardiovascular Intervention highlights the
mechanical effect of orbital atherectomy (OA) and rotational
atherectomy (RA) in treating heavily calcified coronary
lesions.
The article, titled “Optical Coherence Tomography Assessment of
the Mechanistic Effects of Rotational and Orbital Atherectomy in
Severely Calcified Coronary Lesions,” details results from a study
led by Dr. Annapoorna Kini, Professor of Cardiology at the Mount
Sinai Hospital and Icahn School of Medicine, and Director of The
Cardiac Catheterization Lab at Mount Sinai Hospital.
Said study co-investigator, Samin K. Sharma, MD, Director of
Clinical and Interventional Cardiology at The Mount Sinai Medical
Center, “We found that using OA versus RA to treat heavily
calcified coronary lesions resulted in more significant tissue
modification leading to better stent apposition and expansion. This
may translate to lower major adverse cardiac event, or MACE, and
restenosis rates.”
Dr. Kini’s study sought to assess the mechanical effects of RA
and OA on heavily calcified coronary lesions and subsequent stent
placement using optical coherence tomography, an
established medical imaging technique that uses light to
capture three-dimensional images from within arteries and
other biological tissue. The retrospective analysis included 20
consecutive patients who were treated with either RA or OA. While
small case reports have described the mechanistic effect of RA in
calcified coronary lesions, there has been no imaging study to
assess the effect of OA on coronary artery architecture and/or
compare the effects of two atherectomy devices.
David L. Martin, President and Chief Executive Officer of
Cardiovascular Systems, Inc., said, “These results illustrate that
OA delivers less stent malaposition and better stent placement and
expansion. Similarly, our ORBIT II study results showed successful
stent delivery in 98 percent of the procedures, with 96 percent
freedom from severe angiographic complications post OA. Two-year
ORBIT II results also showed a 94 percent freedom from target
lesion revascularization and 81 percent freedom from MACE. We are
excited by the growing clinical evidence supporting the procedural
success of the Diamondback 360® Orbital Atherectomy System
in severe coronary calcium.”
About Coronary Artery DiseaseCAD is a life-threatening
condition and a leading cause of death in men and women in the
United States. 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 American Heart Association, 16.3
million people in the United States have been diagnosed with CAD,
the most common form of heart disease. Heart disease claims more
than 600,000 lives in the United States each year. According to
estimates, significant arterial calcium is present in nearly 40
percent of patients undergoing a percutaneous coronary intervention
(PCI). Significant calcium contributes 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
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 200,000 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.
Coronary Product DisclosuresIndications: The
Diamondback 360® Coronary Orbital Atherectomy System (OAS) is a
percutaneous orbital atherectomy system indicated to facilitate
stent delivery in patients with coronary artery disease (CAD) who
are acceptable candidates for PTCA or stenting due to de novo,
severely calcified coronary artery lesions.
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.
View source
version on businesswire.com: http://www.businesswire.com/news/home/20150519005383/en/
Cardiovascular Systems, Inc.Jack Nielsen,
651-202-4919j.nielsen@csi360.comorPadillaCRTMatt Sullivan,
612-455-1709matt.sullivan@padillacrt.com
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