Stents:

A stent is small tube made of a metal
or fabric mesh that is inserted into the
body to improve the flow of fluids---
usually blood through a blood vessel.


FDA APROVES PROMUS STENT
FROM BOSTON SCIENTIFIC
In November  2011 the FDA approved
the Promus Element Plus drug-eluting
heart stent from  Boston Scientific
Corp, despite concerns about a rare
but potentially serious problem,
because its benefits still outweigh the
possible risks.

The decision followed a disclosure by
the agency  that it was investigating
instances in which the stents - tiny
tubular devices made of wire mesh -
were found to shrink or lengthen after
implantation.

The Promus Element is designed to be
thinner and more flexible to make its
delivery to the artery easier. Complaint
reports about the device show it can
become deformed in cases where
there is calcification of the artery, a
twisted blood vessel or faulty
placement by the surgeon.

The FDA said the problem, known as
longitudinal deformation, has occurred
most frequently with Boston Scientific's
Ion stent, approved in the United
States earlier this year, and the
Promus Element, which had been
available outside the United States.

Promus Element, as of Oct. 31,
showed 136 longitudinal stent
deformation events per 829,372 units
sold.





FDA APPROVES STENTS TO REPAIR
ABDOMINAL ANEURYSMS IN PEOPLE
WITH SMALL ARTERIES
In November 2011 the FDA  has
approved a stent graft system that
provides patients with small arteries
the option of less invasive surgery to
repair their potentially life-threatening
abdominal aortic aneurysm.

An abdominal aortic aneurysm is a
bulge in the part of the aorta that runs
through the abdomen and divides into
the arteries that supply blood to each
leg. Over time, this bulge can become
weak, and the force of normal blood
pressure can cause it to rupture, which
can be life-threatening.

Aneurysms can be repaired through
open surgery or less invasively with
endograft repair using a stent graft
otherwise known as an endograft.

Endografts feature a tube typically
made of plastic material that is
supported by a metal frame or stent.
They are compressed into a delivery
catheter, inserted into the femoral
artery of the leg and then threaded
into position in the weakened portion
of the artery where they are released.
Once released, the endograft expands
against the wall of the aorta to redirect
blood flow away from the aneurysm.

Treatment with a stent graft depends
on the patient’s anatomy. A small
number of people have blood vessels
that are too small in diameter to
accommodate typical endograft
systems on the market.

Manufacturer: TriVascular Inc. os
Santa Rosa, California

The Ovation Abdominal Stent Graft
System (20 millimeter diameter) is not
only small in diameter but it uses a
narrower delivery system than any
other marketed endograft -- 4.7 mm in
diameter compared to 7 mm in
diameter for typical delivery catheters.





FDA APPROVES MEDTRONIC'S
STENT FOR ILIAC ARTERIES
In October 2011 Medtronic  
announced that the FDA has approved
a balloon-expandable stent made from
a cobalt-chromium alloy for the
treatment of narrowed iliac arteries.

Iliac artery refers to several anatomical
structures located in the pelvis.

The Assurant Cobalt Iliac Balloon-
Expandable Stent System is the first to
receive approval to treat narrowed iliac
arteries. The device complements the
company’s self-expanding Complete
SE Vascular Stent, which already has
approval for an iliac indication.

The stent uses the strength of cobalt
chromium and a unique modular
design to create a device with ultrathin,
round, edgeless struts, allowing for
smooth delivery to iliac artery lesions
and conformability to the vessel wall
without sacrificing radial strength.
These features enable the stent to
utilize a 6F sheath for the entire size
matrix — from the smallest (6 mm x 20
mm) to the largest (10 mm x 60 mm)
size — for the treatment of iliac
arteries, according to a press release.

Approval was supported by 9-month
data from the ACTIVE trial, which
studied outcomes in 123 participants
at 17 US sites. The stent demonstrated
technical, procedural and clinical
success in the trial, and was
associated with low rates of major
adverse events, target lesion
revascularization and target vessel
revascularization.



FDA APPROVES ABOTT'S XIENCE
PRIME STENT FOR US MARKETS
In October 2011 the FDA has
approved a next-generation
everolimus-eluting coronary stent,
made by Abott,  for the treatment of
coronary artery disease.

The stent, Xience Prime,  is a cobalt
chromium stent,  designed to be
delivered more easily to complex
lesions and will be available in long
lengths up to 38 mm. Approval of
Xience Prime was based on the SPIRIT
Prime clinical trial, an open-label
registry trial of 500 patients. According
to the company, the trial reached its
primary endpoint and demonstrated at
one year low rates of target lesion
failure and stent thrombosis.

The stent has been approved in
Europe 2 years ago.




JOHNSON & JOHNSON PULLS OUT
OF THE DRUG ELUTING STENT
BUSINESS
In June 2011  Cordis Corporation, a
part of Johnson & Johnson,  
announced it will no longer pursue the
development of the NEVO Sirolimus-
Eluting Coronary Stent in order to
focus on other cardiovascular
therapies where significant patient
need exists. The company will also
stop the manufacture of CYPHER and
CYPHER SELECT Plus Sirolimus-
Eluting Coronary Stents by the end of
2011.

Cypher was the first drug-eluting stent
on the market, but Abbots Xience has
rendered Cypher an afterthought in
the marketplace.

Nevo, based on technology JNJ
acquired in the $1.3B buyout of Conor
Medsystems in 2006, made a big
splash in 2009.   Nevo’s claim to fame
was its Swiss-cheese like drug
reservoirs in lieu of a drug coating
used in other DES products.




FDA APPROVES RX HERCULINK FOR
KIDNEY STENTING IN THE US
In August 2011
 Abbott  received a U.
S. Food and Drug Administration  
approval for the RX Herculink Elite  
Renal Stent System for the treatment
of renal artery stenosis (narrowing of
the main arteries supplying blood to
the kidneys) in patients with
uncontrolled hypertension (high blood
pressure).

Over time, narrowed kidney arteries
can lead to kidney failure and
increased risk of heart disease, stroke
and peripheral artery disease.

The approval was supported by the
HERCULES study, which demonstrated
that RX Herculink Elite is safe and
effective in this patient population. The
study, which enrolled 202 patients in
the U.S., met its primary endpoint, with
a significantly low vessel re-narrowing
rate of 10.5% at 9 months post-
treatment. In addition, 99% of patients
experienced no kidney-related safety
complications within 30 days after
treatment, according to the company.
A reduction in systolic blood pressure
was seen in approximately 78% of
patients at 9 months, with the greatest
reduction seen in patients who had the
highest blood pressure levels at the
start of the study.

RX Herculink Elite has been
commercially available in Europe since
2007 for peripheral indications.

Doctors place kidney stents in the
renal arteries, the blood vessels that
carry blood to the kidneys, or in the
ureters, small tubes that carry urine
from the kidneys to the bladder. Stents
are often used to treat blood vessels
that have become too narrow, a
condition known as stenosis.





POSITIVE RESULTS FOR ABBOTT'S
BIOABSORBABLE STENT
The first of a new generation of stents
have been approved by European
health authorities in  January 2011.
This stent is fully bioabsorbable,
leaving no trace, and allowing the
coronary artery to resume its flexibility
and natural movements with each
heartbeat.

Abbott  received CE Mark approval for
the world’s first drug eluting
bioresorbable vascular scaffold (BVS)
for the treatment of coronary artery
disease.

Abbott’s BVS device restores blood
flow by opening a clogged vessel and
providing support to the vessel until
the device dissolves within
approximately two years, leaving
patients with a treated vessel free of a
permanent metallic implant. Abbott’s
BVS device will be commercialized
under the brand name ABSORB.

The one-year data shows that the
ABSORB device has the potential to
effectively treat coronary artery
disease with the possibility of restoring
natural vessel function in a way not
possible with permanent metallic
implants.


SURGEONS IMPLANTED STENT
INSIDE THE SKULL OF A 14 YEAR
OLD BOY
In August 2010 neurosurgeons at the
University at Buffalo successfully
implanted a stent in an artery inside
the skull of a 14-year-old boy to
prevent a stroke. This  procedure
thought to be the first conducted in an
adolescent.

The boy was home within one day and
remained well at his nine-month
evaluation.


MEDTRONIC'S "SLINKY" STENT
IMPLANTED IN EUROPE
Heart specialists at Southampton
General Hospital (UK) are the first in
Europe to implant an innovative 'slinky'
coil to open a patient's blocked artery.

The new advanced design, known as
the Resolute Integrity Stent System, is
more flexible than other types and can
be used to reach narrow or difficult
blood vessels - its bendy design also
means it has an improved ability to
mould to the shape of an individual's
artery rather than remain rigid.

Consultant cardiologist Dr Iain
Simpson, who performed the first
procedure using the coil, said: "The
new stent is more flexible for getting
around twisty arteries, giving us
another option when treating patients
with coronary heart disease or those
who have suffered a heart attack."



AORFIX IS A STENT FOR ABDOMINAL
ANEURYSMS
Aorfix is a stent graft for abdominal
aortic aneurysms - a widening of the
main artery as it moves down through
the abdomen. It is currently sold in
Europe.
It is made by  Lombard Medical
Technologies.

In August 2011 Lombard Medical
Technologies has filed the final clinical
module for its lead product, the Aorfix
stent graft, with the US Food and Drug
Administration.

Lombard Medical has now filed all six
pre-market approval modules required
for its FDA submission and three of
these have been approved by the FDA.

The company continues to anticipate
FDA approval of Aorfix between the
first and third quarters of 2012.

The Aorfix stent graft has been utilized
successfully in over 1200 patients to
date, compiling the largest clinical
experience in the marketplace for
treating complex, highly tortuous
anatomy.  The uniquely flexible design
of the graft allows for controlled,
precise placement of the Aorfix stent
graft in tortuous anatomy, with
confidence that the stent graft will
remain where it has been deployed
with no fear of kinking.   
The Aorfix  stent graft clinical
experience, combined with the only
European approval for treating
aneurysm neck angles up to 90
degrees in bend, make the Aorfix stent
graft your first graft of choice for
tortuous anatomy.


BIOABSORBABLE STENT TESTED
Boston Scientific Corporation started
enrollment in the EVOLVE clinical trial
to test  its fourth-generation SYNERGY
Coronary Stent.

The SYNERGY Stent uses a
bioabsorbable  polymer and
everolimus drug formulation to create
a thin, uniform coating confined to the
outer surface of the stent. Once the
drug has been delivered, the
bioabsorbable coating resorbs into the
body, leaving behind only a bare-metal
stent. This technology is designed to
provide the same degree of restenosis
reduction as a conventional drug-
eluting stent while offering faster and
more complete vessel healing after
stent implantation.
The SYNERGY Stent features the
same proprietary platinum chromium
alloy and innovative stent design used
in the PROMUS Element Stent.

EVOLVE is a randomized, single-blind,
non-inferiority clinical trial that will
enroll 291 patients at up to 35 sites in
Europe, Australia and New Zealand.




CAROTID STENTING BY CORDIS
For patients with carotid stenosis,
carotid stenting was as effective as
endarterectomy, the randomized,
controlled CREST trial showed.

There was no significant difference in
the primary composite endpoint -- the
four-year rate of periprocedural stroke,
myocardial infarction, or death, or
postprocedural ipsilateral stroke --
between stenting and endarterectomy
(7.2% versus 6.8%, P=0.51),
according to Thomas Brott, MD, of the
Mayo Clinic in Jacksonville, Fla., and
colleagues.
The mortality rate did not differ at any
time during the study.



WRIST ANGIOPLASTY: THE
CATHETER IS PULLED THROUGH
THE WRIST INSTEAD OF THE GROIN
Using the wrist means doctors are
getting access to the heart through the
radial artery in the arm rather than the
femoral artery, which delivers blood to
the lower extremities.

While technically more challenging for
doctors, the radial technique is
associated with fewer bleeding
complications and better long-term
results for patients in a growing
number of studies.

In 2011 only about 8% of cardiac
catheterizations performed in the U.S.
use the radial approach. That's up
from less than 2% about four years
ago.

The rate is well behind several
European countries such as Norway
and France, and Japan, where rates
typically exceed 50% and in some
cases are above 70%.

The radial procedure isn't perfect.
The radial artery is smaller than its
femoral counterpart. Especially in older
patients, it can develop twists and
loops that make it difficult for doctors
to get the catheter to the heart. The
procedure may take longer than the
femoral technique and thus increase
radiation exposure to both patient and
physician. But with practice, doctors
can become proficient and routinely
overcome such challenges.

A trial called Rival has been has been
underway since 2006 comparing the
two methods and it has reported
results in April 2011. It enrolled more
than 7,000 patients at centers around
the world to compare the two
strategies on rates of death, heart
attacks and major bleeding within 30
days of the procedure. It was led by
Sanjit Jolly of McMasters University in
Canada.

The result is as follows: While both
methods are equally effective in
clearing heart arteries, going through
the wrist results in fewer complications.
The wrist approach cuts the bleeding
risk by nearly 60 percent. Bleeding
complications with this approach are
less common in high-risk individuals
such as the elderly and those with
acute coronary syndromes.
The wrist approach lowers hospital
costs as the puncture site can be
bandaged and patients are discharged
quicker. Moreover, it overcomes the
discomfort of lying flat for hours in
order for the incision site to seal up.