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FDA: Cook Medical’s stent met efficacy, safety goals

October 11, 2011

A drug-coated stent from Bloomington-based Cook Medical met safety and effectiveness goals in the treatment of blocked femoral arteries, according to a staff report by U.S. regulators weighing whether to clear the device for sale.

Peripheral vascular devices, including stents, angioplasty balloons and synthetic grafts, generated $4.3 billion in global revenue last year and may earn $5.6 billion in 2014, according to Technavio, a market research firm in Elmhurst, Ill.

 An estimated 8 million to 12 million people in the U.S. are affected by peripheral arterial disease affects, according to the Peripheral Arterial Disease Coalition in Lakewood, Colo. The disease can cause leg pain and raise heart-attack and stroke risks.

Bypass surgery and angioplasty, in which a tiny balloon is inserted into the artery to clear the blockage, are among the standard treatments for the disease.

Clinical trials showed closely held Cook’s stent, the Zilver PTX, worked as well as or better than angioplasty and non-medicated stents in unclogging vessels, Food and Drug Administration staff said in a preliminary review released Tuesday on the agency’s website. Outside advisers to the FDA will meet Oct. 13 to evaluate the findings.

Cook's device would be the first drug-coated stent approved in the U.S. to treat peripheral vascular disease in the largest artery of the upper leg. The stent could reduce leg amputations and painful bypass surgeries, the company said after winning approval for the device in Europe two years ago.

In a study of 479 patients, “there were no signals regarding elevated rates of death, stent thrombosis, or stent fracture” in patients treated with Cook’s device,” FDA staff said in the report. “Limited conclusions can be drawn” from that sample size “regarding the detection of rare adverse events.”

If the device is approved, the company should be required to conduct follow-up studies to further assess the risk of side effects or complications, agency reviewers said in the report.

Abbott Laboratories of Illinois and C.R. Bard Inc. of New Jersey are among the manufacturers of devices that treat arterial blockages in the leg.

C.R. Bard won FDA approval in 2009 for a non-drug-coated stent to treat femoral artery disease. That device, known as LifeStent, is a flexible mesh tube that expands inside a clogged vessel and holds it open to restore blood flow.

The Zilver PTX device from Cook also props open the femoral artery and delivers the drug paclitaxel to reduce the risk that fatty deposits will form new blockages.

Cook’s drug-coated stent, if approved, “can be a serious competitor to other companies in this space,” Bruce Jackson, an analyst with Morgan Joseph TriArtisan Group in New York, said Tuesday in an e-mail.

Restenosis, or a recurrence of arterial blockages, occurred in 24 percent of patients treated with Cook’s drug-coated stent after 12 months, and 34 percent of patients treated with angioplasty, according to the FDA report.

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