Peripheral Arterial Disease procedures:
PAD is an obstruction of blood vessels,
usually in the leg, causing pain,
difficulty in walking and leading
eventually to amputation.
Peripheral artery disease is the result
of atherosclerotic plaque buildup in the
arteries supplying blood to the legs.
Significant stenosis of these arteries
can lead to symptoms including leg
cramping, ulcers or sores in the feet,
difficulty in walking, and possibly
gangrene requiring amputation.
Currently, PAD is treated in the US
either through balloon angioplasty,
bare metal stenting or atherectomy.
Leading manufacturers of peripheral
vascular stents include Cordis, which
recently announced it will leave the
coronary drug-eluting stent market,
Boston Scientific and Abbott
Laboratories. Together the top three
manufacturers account for more than
half of the PV stent market.
DRUG ELUTING STENT BY COOK
Cook Medical’s Zilver PTX drug-eluting
stent is likely to be approved for use in
the United States and launch in the
first half of 2012.
In October 2011 the Food and Drug
Administration’s (FDA) Medical
Devices Advisory Committee
recommended Cook Medical’s Zilver
PTX Drug-Eluting Stent for the
treatment of peripheral artery disease
(PAD) in the superficial femoral artery
Zilver PTX would be the first drug-
eluting stent in the US indicated for the
treatment of PAD in the SFA.
According to marketing predictions,
treatment of PAD in the
femoropopliteal arteries will grow 12
percent per year through 2015,
reaching 250,000 stent procedures
Cook Medical hopes to sell the device
in the US. The device already received
CE Mark approval in Europe in 2009.
According to Cook Medical’s website,
the 1-year fracture rate was just 0.9%
and it demonstrated 50% reduced
restenosis rate at 2-years when
compared to bare-metal stenting.
Zilver PTX results show a higher rate
of patency (ability to keep vessels
open) than PTA balloons or bare metal
stents, at both one year and two year
trial results. Zilver PTX is currently
sold in 48 countries.
AASTROM SHOWS GOOD RESULTS
IN PHASE 2 TRIAL
In September 2011, in a phase 2 study,
a personalized cellular therapy
developed by Aastrom Biosciences
significantly restored damaged tissue
in the legs of patients with arteries that
are severely blocked.
Aastrom will soon begin a phase 3
study to determine whether the cellular
therapy, which is custom grown for
patients from their own bone-marrow
stem cells, can reduce amputations
and prolong survival in patients with
severe cases of critical limb ischemia
Patients with chronic CLI have
obstructed arteries and reduced blood
flow in the arms and legs, which can
lead to open wounds and amputation
in the most severe cases. CLI affects
about 1 million people in the U.S. each
year and leads to about 160,000 limb
amputations each year.
The economics of personalized cellular
therapies have come under some
added scrutiny because of the poor
gross margins posted by Dendreon in
recent quarters for Provenge. While
Aastrom's ixmyelocel-T is also custom-
made for each patient like Provenge,
the manufacturing process is more
automated and cost efficient, said CEO
In the mid-stage study, 72 patients with
CLI were treated with a one-time series
of 20 injections in the legs and foot
containing either Aastrom's cellular
therapy, known as ixmyelocel-T, or a
PLURISTEM STEM CELL THERAPY
WORKS WELL FOR PERIPHERAL
Pluristem Therapeutics said early
clinical trials show its placenta-derived
cell therapy is safe and improves
quality of life in patients with peripheral
artery disease, or PAD.
The Phase I trials, conducted at three
university hospitals in the United
States and one in Berlin, show the
cells are effective in treating the end
stage of PAD, called critical limb
ischemia, the Israel-based biotech
Unlike many other companies that use
embryonic stem cells, Pluristem
harvests cells from the placenta after a
woman gives birth, so there is no
ethical issue on using embryos.
"We have proved we can use the
placenta as a source for a product that
doesn't require a match between the
donor and patient," Chief Executive
Zami Aberman said.
While an estimated 20 million people in
the United States suffer from PAD,
Pluristem is targeting the 2.5 million
who are in the end stage. Insurance
companies pay about $10 billion a
year to treat those patients.
Pluristem estimates it can slash
reimbursement costs of insurance
companies by about 50 percent, as the
cost of treating PAD using its therapy,
called PLX-PAD, is significantly
cheaper than current methods, which
run to around $40,000 per year.
Present treatment for PAD include a
bypass to improve circulation, drugs to
improve bloodstream and oxygen
"These can stop progress of the
disease for a while but do not change
the situation," Aberman said.
Pluristem's clinical trials showed
patients experienced improvement in
bloodstream, pain and quality of life for
six months following a 20-minute
session of injections.
AASTROM PROCEDURE TESTED
FOR TREATING PAD USING STEM
Aastrom to Pursue Phase 3 Clinical
Program in CLI.
Critical limb ischemia (CLI), the most
severe form of peripheral vascular
disease, leads to over 160,000 major
limb amputations per year in the U.S.
Data suggests that approximately
twenty percent of patients will die within
the first 6-12 months of CLI onset.
Current therapeutic options are limited
and often ineffective for the most
severely affected patients.
Aastrom Biosciences is developing
autologous cellular therapies for use in
the treatment of severe cardiovascular
diseases. The company's proprietary
cell-processing technology enables the
production of cellular therapies using a
patient's own bone marrow that can be
delivered directly to damaged tissues.
Aastrom is conducting two Phase 2
clinical trials to treat dilated
cardiomyopathy and a Phase 2b
clinical trial to treat critical limb
The bone marrow sample taken from
the patient is the first step of the
process contains a range of cells
including hematopoietic and
mesenchymal cells. These cells are
known to play important roles in the
natural healing mechanisms of the
human body. Aastrom's patented
single-pass perfusion technology
controls gas and cell culture media
exchange to enable the replication of
these naturally occurring cells. The
cellular therapy resulting from this
process contains expanded
populations of mixed stem and
progenitor cells to support the
regeneration of cardiovascular tissue.
Aastrom's process works exclusively
with adult stem cells derived from and
administered to the same patient. This
approach reduces the risk of rejection
and increases the likelihood of
integration with the surrounding
tissues, eliminating the need for
Atherectomy : plaque is drilled thru
with laser by eV3 equipment.
Diamondbak 360 by Cardiovascular
Systems pulverizes plaque into bits
smaller than blood cells;
High energy cool laser by
Crosser catheter by Flowcardia
vibrates to break up plaque in patient’s
leg and heart arteries, it works by
creating high frequency vibrations at
its tip that pulverize the plaque;
Wildcat catheter by Avinger Inc to
break up plaque in leg arteries;