Cook Inc. plans to slide its coated-stent ambitions from the heart down to another region of the body where a multimillion-dollar market awaits.
The Bloomington-based medical-device maker recently started testing a product that uses the same drug Cook put on a coronary stent it tried to develop a couple of years ago with Guidant Corp.
Instead of treating arteries near the heart, the Zilver PTX stent targets blockages in the major artery that runs through the thigh. Cook is the first company to conduct a U.S. test for a coated stent in this new frontier, company officials said, and a breakthrough could yield big market gains.
But analysts said competition could heat up.
This latest coated stent scenario presents a marked contrast from the one Cook and Guidant envisioned in 2002. Back then, the two companies teamed up on plans to develop a coronary stent coated with the drug paclitaxel.
Indianapolis-based Guidant announced that year that it planned to buy Cook for $3 billion. However, the companies later called off the deal after running into problems during a clinical study.
Guidant has since gone on to partner with Johnson & Johnson subsidiary Cordis Corp. to co-promote the Cypher drug-eluting coronary stent. Last December, New Jersey-based J&J took the relationship a step further when it announced plans to buy Guidant in a deal worth $25 billion.
The companies expect a third-quarter closing, pending a review by the Federal Trade Commission. Guidant shareholders will vote on the deal April 27.
Cook, in turn, rebounded by looking away from the heart. The company combined a stent originally developed to treat the bile duct with paclitaxel, the drug developed by Canadian-based Angiotech Pharmaceuticals that Cook had hoped to use in the Guidant collaboration.
The result, Cook leaders said, could open the doors to a new market for coated stents.
Stents are tiny metal scaffolds inserted into clogged arteries to help prop them open. Coated ones help prevent arteries from reclogging.
The Zilver PTX stent is designed to treat peripheral arterial disease, a condition that affects roughly 10 million Americans. The disease can make walking painful and can lead to amputation in extreme cases, according to Dr. Chuck McIntosh, a Cook vice president of medical science and technology officer.
"It's pain, it's ulcers on the leg sometimes from decreased blood supply, and it simply limits your ability to walk great distances or do the activities that would involve walking or running," he said.
Common treatments now include medicine that can be ineffective, bare metal stents that can clog again or bypass surgery, said Dr. Sean Lyden, a vascular surgeon at the Cleveland Clinic. None of these, he said, are reliable.
"Certainly, if you have something that is durable and can help people who have to stop every hundred yards because their legs are killing them, that would be a good thing," he said.
Developing a stent that suits the thigh's femoropopliteal artery and treats this disease presents some unique challenges, McIntosh said. For instance, that artery compresses whenever someone crosses his or her legs, so the stent must be able to compress and return to its original shape.
"Every time we walk or bend a knee or get into a sitting position or something like that, it puts added stress on the stent," McIntosh said.
The Zilver PTX stent has gone through animal and engineering testing. Last month, Cook enrolled its first patient in a study that eventually will involve 60 people.
The study will involve 10 U.S. locations, including St. Vincent Indianapolis Hospital, where vascular interventional radiologist Dr. Katharine Krol plans to participate.
Cook hopes to launch a bigger trial after submitting the results of this one to the U.S. Food and Drug Administration. The stent could then hit the market by the end of 2007 or in 2008, depending on the results of that bigger study and on approvals from the U.S. Food and Drug Administration, McIntosh said.
That U.S. market for bare metal stents to treat these thigh arteries currently is $20 million to $25 million, according to Rob Lyles, director and global business unit leader for Cook's diagnostics and interventional products unit.
He said that market could grow 10 percent to 15 percent a year, and Cook can grab a big chunk of it. Advances in technology lead to big gains in a short time span.
Boston Scientific Corp., for example, captured more than 60 percent of the drugcoated stent market for coronary arteries "overnight" once it entered with its Taxus Express stent, Lyles said. That stent also uses paclitaxel.
"You can swing big market share with the right kind of advance, no doubt about it," he said.
Comparisons to the coronary stent market only carry so far. The market for stents that treat peripheral arterial disease has drawn little attention from analysts. David Toung, an analyst for New York-based Argus Research, noted that thigh artery blockages aren't as "life critical" as coronary problems.
"Not to say it's an insignificant market; I just don't think it's going to be big," he said.
No one currently markets a drug-coated stent to treat this thigh artery in the United States. But competition could be on the way. Lyden, the vascular surgeon, said J&J has tested a similar product in Europe and had problems with the stent.
Boston Scientific also is looking into the market, said Thom Gunderson, an analyst with Minneapolis-based Piper Jaffray & Co.
If they succeed with the Zilver PTX stent, Cook officials plan to explore other aspects of peripheral arterial disease as well. But moving from the knee to the ankle might require a different drug or different stent technology, McIntosh noted, adding, "We haven't advanced to that point yet."
Gunderson called Cook's latest stent development "an interesting idea.
"They're one of the players in peripheral arterial disease," he said. "It's demonstrated that it's just too difficult for them in the coronaries."
Cook, which employs 5,000 people worldwide and 2,000 in Indiana, has no plans to take another shot at the market for coated stents that treat coronary arteries, spokesman David McCarty said.