New Study Demonstrates Exceptional Performance With Cardiovascular Systems’ Diamondback 360® Coronary Orbital Atherectomy ...
May 20 2021 - 4:00AM
Business Wire
Cardiovascular Systems, Inc. (CSI®) (NASDAQ: CSII), a medical
device company developing and commercializing innovative
interventional treatment systems for patients with peripheral and
coronary artery disease, announced today that results from a
real-world optical coherence tomography (OCT) imaging study of
coronary OAS patients were released at EuroPCR 2021.
The study conducted by Surendra Avula, MD, et al, at the
University of Illinois, Chicago, was designed to assess the dual
mechanism of action of orbital atherectomy. Twenty consecutive
patients with severely calcified lesions identified by coronary
angiography were enrolled and treated by a single operator. All
patients received a prespecified treatment algorithm including at
least three runs of orbital atherectomy at low speed with OCT
imaging pre- and post-OAS prior to stenting.
There were no angiographic complications in any patients,
including 0% dissection, 0% perforation and 0% slow flow/no reflow.
Using OCT assessment post-atherectomy, 100% of treated lesions
showed calcium fracture (defined as fissures, craters and/or smooth
concave ablation) effecting both superficial and deep calcium.
Stent delivery and subsequent stent expansion was subsequently
achieved in all patients (100%).1
Said Avula, “Orbital atherectomy is used to facilitate stent
expansion in severely calcified lesions. In this small
observational study we utilized OCT to demonstrate the dual
mechanism of action of orbital atherectomy. We clearly observed
sanding of intima and fractures of both superficial and deep
calcium in the coronary tree. This strategy of peri-procedural OCT
imaging in combination with lower speed orbital atherectomy is a
paradigm shift in the effective treatment of the calcified coronary
tree, and represents a new standard for patient outcomes and
safety.”
Severe calcification in coronary lesions impedes optimal stent
delivery, expansion and apposition and leads to increased
procedural complications and overall inferior results. The
Diamondback 360® Coronary OAS uses a powerful dual mechanism of
action to treat both superficial and deep calcium, thus restoring
native vessel compliance, simplifying procedural workflow, and
enhancing PCI outcomes.
Scott Ward, Chairman, President and Chief Executive Officer,
said, “This study highlights the benefits of imaging to optimize
vessel preparation and reinforces the efficacy of orbital
atherectomy’s unique mechanism of action which both ablates and
fractures calcium.”
About Coronary Artery Disease (CAD)
CAD 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 30% 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 system treats calcified and
fibrotic plaque in arterial vessels throughout the leg and heart
and addresses many of the limitations associated with existing
surgical, catheter and pharmacological treatment alternatives. For
additional information, please visit www.csi360.com and connect on
Twitter @csi360.
Product Disclosure:
Indications: 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 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 these devices to
sale by or on the order of a physician.
The Diamondback 360® Coronary OAS is FDA PMA approved.
1 Ayat, Y, et al. Observational Study Evaluating the Efficacy of
Orbital Atherectomy in Treating Calcified Coronary Lesions.
Presented at EuroPCR 2021.
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Cardiovascular Systems, Inc. Jack Nielsen Vice President,
Investor Relations & Corporate Communications (651) 202-4919
j.nielsen@csi360.com
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