US FDA advisers back Cook stent for leg arteries
* Could be first drug-coated stent for peripheral arteriesOct 13 (Reuters) - U.S. health advisers on Thursday
unanimously backed a new Cook Medical stent coated with a
common cancer-fighting drug to treat clogged arteries in the
thighs.A panel of outside experts to the Food and Drug
Administration said the Zilver PTX stent was safe and effective
for keeping blood vessels above the knee free from plaque.The device could become the first drug-coated stent to
treat peripheral arteries in the U.S. market if the FDA follows
the recommendation of the panel, which it is not required to
do.Privately-held Cook Medical, based in Bloomington, Indiana,
competes against device makers such as Boston Scientific and Covidien , which also make leg stents, in a
stent market estimated at $5 billion worldwide.Stents are tiny mesh-like tubes used to prop open arteries
that have been cleared of blockages from plaque, a build-up of
cholesterol, fatty deposits and scar tissue.”This hasn’t really been about bringing a product to
market; it’s been about bringing a new option to patients,”
David Timlin, distinguished regulatory affairs advisor at
Medtronic Surgical Technologies and the industry
representative on the panel, said at the meeting, which was
webcast.”It’s just a prime example of how things should work,
especially in an environment where industry and the FDA are
sometimes adversarial,” he said, echoing generally glowing
reviews from panel members.The most commonly used drug-coated stents are placed in
heart arteries following angioplasty procedures, when doctors
open clogged arteries with an inflated balloon.The Cook Medical stent is coated with paclitaxel, an
anti-cancer drug. The drug is used to help prevent re-clogging
of the artery by inhibiting the growth of scar tissue.The device was approved for sale in Europe in 2009.The Zilver PTX stent is meant to treat peripheral arterialdisease, which according to the company affects about 30
million people a year. The disease develops when arteries
outside the heart build up plaque, causing them to narrow and
restrict blood flow.Patients with the disease may have pain when walking, sores
or ulcers, or weakness in the legs. Total loss of circulation
can lead to gangrene and limb amputation, although that is
rare.
