First drug-eluting stent for femoral artery blockage available in EU
13 October 2009
In a breakthrough development that could dramatically reduce the
number of leg amputations and painful bypass graft surgeries performed
annually on European patients, a first-of-its kind drug-eluting stent
for a widespread form of peripheral arterial disease (PAD) is now
available in the European Union.
Created by Cook Medical, the new CE Marked Zilver PTX Drug-Eluting
Peripheral Stent is widely expected to improve the standard of care for
many patients with serious blockages in the superficial femoral artery
(SFA) by creating an effective, new treatment option.
In the largest clinical trial of its kind, the Zilver PTX stent was
shown to effectively bridge the gap between the patient results achieved
using open surgical bypass graft procedure — which is typically more
painful and requires a longer hospital stay for the patient — and the
less traumatic, but typically less effective, earlier minimally invasive
treatment options for PAD such as balloon angioplasty and bare metal
stenting.
“With the Zilver PTX stent, Cook has introduced a true landmark
device that can reduce the number of PAD patients having to endure the
trauma of leg amputations and bypass surgeries,” explained Rob Lyles,
vice president and global leader of Cook Medical’s peripheral
intervention unit. “Clinically proven, polymer-free and exceptionally
durable, we expect the Zilver PTX stent to become the new standard of
care for PAD in the SFA.”
Cook also has initiated a first-of-its-kind open clinical database on
SFA treatments. The SFA Open-Registry provides physicians with an
opportunity to exchange ongoing, real world treatment results. Utilizing
an intuitive web interface, clinicians may track their patients, view
the medical community’s trends in treating PAD and determine the most
effective treatment options. Transparency will be a central objective of
the SFA Open-Registry, with results for all treatment types available to
participating physicians.
Another key breakthrough is Cook’s commitment to a patient-focused
strategy that should make the device available to virtually any PAD
patient who needs it, Lyles explained. As part of its ongoing corporate
mission to help reduce global health care delivery costs, Cook has
adopted a unique ‘affordable innovation’ strategy aimed at reducing any
potential financial or reimbursement barriers to its widespread adoption
as the standard of care for PAD in the SFA.
The Zilver PTX stent first expands and holds open the artery to
restore blood flow. The device then delivers the drug paclitaxel to the
cells in the vessel wall to reduce the risk of new blockages forming. In
a major advance over previous drug-eluting technologies, the stent
achieves targeted drug delivery without using a polymer to adhere the
drug to the stent body. This eliminates the potential patient risks
associated with polymer-coated devices, including clot formation and
inflammation.
In the United States, the Zilver PTX Drug-Eluting Stent is an
investigational device not available for sale yet.
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