Breakthrough drug-eluting stent to treat peripheral artery disease
available in Europe
20 August 2009
Surgeons in the UK have completed patient implants of the first CE
Mark approved drug-eluting stent designed specifically to treat severe
blockages in the largest artery in the leg.
Approval of the polymer-free Zilver PTX Drug-Eluting Peripheral Stent
from Cook Medical represents a global landmark in effective peripheral
intervention for treating peripheral artery disease (PAD), a chronic
disease affecting tens of millions of patients worldwide that is a
leading cause of leg amputation and shortened lifespans.
Cook’s Zilver PTX is specifically designed and approved to treat PAD
affecting the main blood vessel in the thigh, the superficial femoral
artery (SFA). It is a self-expanding stent made of nitinol, a space-age
‘shape memory’ metal that offers unique mechanical advantages for a
stent in the SFA.
By eliminating the need for a polymer or plasticising agent to hold
the drug to the stent body, Cook has created a medical breakthrough that
solves two key problems. First, it allows targeted delivery of a drug (paclitaxel)
proven to reduce the renarrowing (restenosis) of arteries opened using
Second, by eliminating the need for a polymer, which was left behind
on the body of earlier drug-eluting stents after the drug dissolved into
the surrounding tissues, Zilver PTX avoids the potential patient risks
posed by leaving a permanent foreign, plastic substance in the body. In
addition, the Zilver stent was proven during its clinical trial to be
the most durable peripheral stent available, suggesting even greater
patient safety, according to the clinical trial data.
The CE Mark follows the world's largest-ever clinical trial for a
peripheral stent, led by Dr. Michael Dake, professor in the Department
of Cardiothoracic Surgery at Stanford University Medical School and
medical director of the Cath/Angio Laboratories at Stanford University
Medical Center, Palo Alto, California.
The data collected in the Zilver PTX registry involved 791 patients
from Europe, Russia, Canada, and Korea and demonstrated highly positive
results. Only 8 per cent of patients with de novo (new) lesions needed a
reintervention to reopen the artery in the first 12 months — a rate
significantly surpassing existing treatments for PAD in the SFA, such as
balloon angioplasty and bare metal (non-drug-eluting) stents.
Also, specific patient groups that are often very hard to treat, such
as diabetics and patients with in-stent restenosis (those treated
previously with a noncoated stent), were shown in the trial to benefit
from the Zilver PTX. As the trial data indicate, the superior results
achieved in the first year have been largely maintained throughout 24
months, an important clinical milestone. In comparisons with other
trials published, the Zilver PTX stent showed a reduction in
re-intervention of between 50 per cent and 75 per cent, an important
“The awarding of the CE Mark is set to herald a revolution in the
treatment of peripheral arterial disease,” comments Dr. Michael Dake.
“This global study proves that the Zilver PTX has the integrity, safety,
and durability needed to successfully address many of the well-known
limitations of current treatments for the management of PAD.”
Rob Lyles, global leader and vice president of Cook Medical's
Peripheral Intervention division states, “We've specifically designed
the Zilver PTX to be safer and more effective for PAD patients by
engineering this device for the unique demands of treating this disease
in the SFA. It’s polymer free, it’s fracture resistant, and through the
largest trial of its nature in history, it’s been clinically proven to
be significantly more effective in treating peripheral arterial disease
in the SFA than other treatment modalities.
"Our unique ability to adhere the drug to the stent without using a
polymer is a major clinical advantage. It eliminates the risk some
patients may face due to reactions and other potentially poor outcomes
that are associated with polymer coatings used on current generations of
drug-eluting stents. It's a truly exciting time for Cook Medical and our
partners, as well as for physicians and patients alike. With the
European launch of this first-of-its-kind 21st century medical
technology, we are truly at the vanguard of a revolution in peripheral
About peripheral artery disease (PAD)
PAD is one of the fastest-growing and most pervasive diseases of our
time, and it is estimated to affect 27 million individuals in Europe and
North America1,2,3. Yet, approximately only a quarter of these people
have any symptoms at all. The ‘silent’ nature of this condition can
result in a number of patients being diagnosed only when their condition
has progressed to the severe stage. In many countries, untreated PAD is
the leading cause of leg amputation, and previous treatments such as
bypass surgery and the use of angioplasty are much more invasive and/or
only have shown only limited long-term success rates.
Following more than 1,200 patients treated worldwide during its
clinical evaluation and CE Mark approval on 24 July 2009, the first
commercial implantations of the Zilver PTX stent were conducted on 10
August 2009 in a coordinated effort by physicians in the United Kingdom,
Germany, France, Holland, Belgium, Sweden, Switzerland and Spain.
In the United States, the Zilver PTX drug-eluting stent is an
investigational device not available for sale.
In the UK Dr. Nick Chalmers from the Manchester Royal Infirmary
participated in the first commercial use.
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