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Indications for Use
The Integrity Coronary Stent Systems are indicated for improving
coronary luminal diameter in patients with symptomatic ischemic
heart disease due to discrete de novo or restenotic lesions with
reference vessel diameters of 2.25--4.0 mm and ≤30 mm in length
using direct stenting or predilatation.
in ation of an angioplasty balloon or proper placement of a stent
or stent delivery system
The long-term e ects of stents and the risks associated with lifelong
carrying of these implants are unknown. This lack of knowledge
patient prior to implantation.
procedure only. Do not resterilize. Use by the "Use by" date noted
on the package.
perform implantation of the stent. Use of an Integrity Coronary
Stent System requires advanced coronary angioplasty technical
obviate the need for formal training in the use of the device.
cannot be removed and placed on another balloon catheter for
a kinked metal shaft may result in breakage of the shaft. If the
expansion of the stent and di culty in deployment of the stent.
Do not pre-in ate balloon prior to stent deployment. Use balloon
preparation technique described within this instructional material.
appropriately positioned in the vessel. If the position of the stent is
previously stented segment may cause procedural complications
artery vasodilator therapy according to current medical guidelines
and manufacturer s instructions.
deformation of the stent.
contact with each other may increase the potential for corrosion.
Data obtained from in vitro corrosion tests using a cobalt alloy
do not suggest an increased risk of in vivo corrosion.
torquing and removing one or both guidewires to avoid
entanglement. It is recommended that one guidewire be
completely withdrawn from the patient before removing any
emergency coronary artery bypass graft surgery can be readily
therapy is critical to successful stent implantation and follow-up.
segment containing the stent. The long-term outcome following
repeat dilatation of endothelialized coronary stents is unknown at
Potential Adverse Events
The following complications may be associated with the use of
Instructions for Use for a more
order of a physician.
LifeLine Customer Support
National Quality Forum released a list of 27
"Never-Events," referring to particularly
shocking medical errors (such as wrong-
site surgery) that should never occur, and
the Centers for Medicare and Medicaid
Services (CMS) initiated voluntary public
reporting of quality indicators. "Sentinel
events," or an unexpected occurrence
involving death or serious physical or psy-
chological injury not related to the natural
course of the patient's illness, required im-
mediate investigation and reporting to the
Joint Commission. Providers were then
required to conduct root cause analysis
and make remedies.
In 2003, Congress enacted the Medicare
Modernization and Accountability Act,
which chartered The Joint Commission's
Healthcare Quality Accreditation Association.
"Tracer" interviews that follow a patient re-
cord rather than examining policy manuals
were implemented. In 2006 the CMS for-
malized a list of 10 Quality (Core) Measures
for voluntary public reporting, adding seven
more measures the next year. In 2008 the
CMS promoted value-based purchasing and
patient-centric care delivery models, themes
that were incorporated in the 2009--2010
push toward health reform.
Today the Patient Protection and
A ordable Care Act of 2010 includes regula-
tions on quality-based payment, accountable
care, bundled payments, clinical e ective-
ness and non-payment for hospital-acquired
conditions and avoidable readmissions---all
patient-safety-related features that origi-
nated in the last decade. As the future of
U.S. health care is being debated, it is certain
that payers, regulators and the public will
continue to demand quality improvement in
all aspects of health-care delivery.
sta ng to device
ensuring a steady
flow to and from
continued on next page
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