Cook Medical Device to Prevent Leg

Amputations Worked in Study

By David Olmos
Sept. 24 (Bloomberg) -- A drug-coated stent from Cook Medical, the maker of devices
for minimally invasive medical procedures, was more effective than standard therapy for
patients with blockages in an upper-leg artery, a study found.
With the Cook stent, patients’ arteries reclogged in 17 percent of patients after one year
compared with 33 percent of those who underwent treatment with an artery-clearing
procedure known as angioplasty and an older type of stent, according to the one-year
study presented today at the Transcatheter Cardiovascular Therapeutics meeting in
Washington, D.C.
The Cook device would be the first drug-coated stent approved in the U.S. as an
alternative to bypass surgery for treatment of peripheral arterial disease, a condition
affecting about 12 million Americans, according to the National Institutes of Health.
Closely held Cook, based in Bloomington, Indiana, has filed for U.S. approval of the
stent and will face competition in the $3.4 billion market from Abbott Park, Illinois-based
Abbott Laboratories and Minneapolis-based Medtronic Inc.
“This is an important step toward reducing amputations, bypass and repeat intervention in
patients with peripheral artery disease, which is very difficult to treat,” said Michael
Dake, a surgeon at Stanford University Medical Center in Palo Alto, California, and the
study’s principal investigator, in a statement.
Peripheral arterial disease occurs when plaque clogs arteries and disrupts blood flow to
the legs and other parts of the body. Patients often have cramps and tiredness in the legs
or hips when walking. They have more than four times the risk of heart attack and stroke
and untreated conditions can lead to leg amputations, according to the American Heart
Association.
Bare Metal Comparison
Cook funded the study, which also compared use of the its device with a bare-metal stent
alone. By that measure, 10 percent of patients with the Cook device had a renarrowing of
their arteries that blocked blood flow compared with 27 percent treated with a bare-metal
stent, according to the study.
“We wanted to see if we can come up with a more durable procedure that will last
longer” for restoring blood flow to the legs, Sanjay Misra, an interventional radiologist at
the Mayo Clinic in Rochester, New York, and an investigator in the study, said in a Sept.
16 telephone interview.
The market for peripheral artery disease products is projected to grow 15 percent to $3.9
billion this year from $3.4 billion in 2009, said Teri Minor, a senior analyst with Frost &
Sullivan’s in San Antonio, Texas, in a Sept. 17 telephone interview.
‘New Era’
The 479-patient study is the first to test drug-coated stents to clear blockages in the
largest artery of the upper leg and a successful outcome may “usher in a new era” for
treatment of the disease, said Gregg Stone, director of cardiology at Columbia University
Medical Center in New York, in a Sept. 14 telephone interview..
The use of stents coated with drugs to prevent the build-up of scar tissue has become
commonplace in heart surgery, and the study looked at how effective such stents would
be when used in the leg, Dake said in a Sept. 16 telephone interview.
The most common treatment for clots in the leg is a procedure known as balloon
angioplasty, which inserts a tiny balloon to clear the clogged vessel. In some cases the
angioplasty is followed by placing bare-metal stents, which are not coated with drugs, to
hold open the artery in patients.
The bare-metal stents have been prone to fracture when placed in the leg because of
repeated movement and the stress of walking, Misra said.
Zilver PTX
The Cook stent, called Zilver PTX and already sold in Europe, does not include a layer of
chemical polymers, commonly used on drug-coated stents, to hold the medicine in place
so it can be released gradually. When used for heart stents, the polymers may inhibit
proper healing and cause long-term side effects.
“If you could do without the polymer, that takes one less thing out of the equation that
could have a negative effect,” Dake said.
Cook filed for U.S. approval for its Zilver PTX stent in June for use in treating blockages
in the femoral artery, a large blood-carrying vessel that runs from the lower groin to the
thigh.
Abbott and Medronic either market or are testing stents and inflatable-drug coated
balloons for treatment of clogged leg arteries.
“The market is pretty attractive right now,” said Jan Wald, an analyst with Noble
Financial Group, in a Sept. 17 telephone interview. “We’re starting to see companies
spend more time and focus more on this.”
To contact the reporter on this story: David Olmos in San Francisco at
dolmos@bloomberg.net
To contact the editor responsible for this story: Reg Gale at Rgale5@bloomberg.net
Last Updated: September 24, 2010 11:12 EDT