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

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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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  1. Cramer agrees...says don't buy it and sell it if you own it! Their "pay to play" cost is this issue. As long as they charge customers, they never will attain the critical mass needed to be a successful on company...Jim Cramer quote.

  2. My responses to some of the comments would include the following: 1. Our offer which included the forgiveness of debt (this is an immediate forgiveness and is not "spread over many years")represents debt that due to a reduction of interest rates in the economy arguably represents consideration together with the cash component of our offer that exceeds the $2.1 million apparently offered by another party. 2. The previous $2.1 million cash offer that was turned down by the CRC would have netted the CRC substantially less than $2.1 million. As a result even in hindsight the CRC was wise in turning down that offer. 3. With regard to "concerned Carmelite's" discussion of the previous financing Pedcor gave up $16.5 million in City debt in addition to the conveyance of the garage (appraised at $13 million)in exchange for the $22.5 million cash and debt obligations. The local media never discussed the $16.5 million in debt that we gave up which would show that we gave $29.5 million in value for the $23.5 million. 4.Pedcor would have been much happier if Brian was still operating his Deli and only made this offer as we believe that we can redevelop the building into something that will be better for the City and City Center where both Pedcor the citizens of Carmel have a large investment. Bruce Cordingley, President, Pedcor

  3. I've been looking for news on Corner Bakery, too, but there doesn't seem to be any info out there. I prefer them over Panera and Paradise so can't wait to see where they'll be!

  4. WGN actually is two channels: 1. WGN Chicago, seen only in Chicago (and parts of Canada) - this station is one of the flagship CW affiliates. 2. WGN America - a nationwide cable channel that doesn't carry any CW programming, and doesn't have local affiliates. (In addition, as WGN is owned by Tribune, just like WTTV, WTTK, and WXIN, I can't imagine they would do anything to help WISH.) In Indianapolis, CW programming is already seen on WTTV 4 and WTTK 29, and when CBS takes over those stations' main channels, the CW will move to a sub channel, such as 4.2 or 4.3 and 29.2 or 29.3. TBS is only a cable channel these days and does not affiliate with local stations. WISH could move the MyNetwork affiliation from WNDY 23 to WISH 8, but I am beginning to think they may prefer to put together their own lineup of syndicated programming instead. While much of it would be "reruns" from broadcast or cable, that's pretty much what the MyNetwork does these days anyway. So since WISH has the choice, they may want to customize their lineup by choosing programs that they feel will garner better ratings in this market.

  5. The Pedcor debt is from the CRC paying ~$23M for the Pedcor's parking garage at City Center that is apprased at $13M. Why did we pay over the top money for a private businesses parking? What did we get out of it? Pedcor got free parking for their apartment and business tenants. Pedcor now gets another building for free that taxpayers have ~$3M tied up in. This is NOT a win win for taxpayers. It is just a win for Pedcor who contributes heavily to the Friends of Jim Brainard. The campaign reports are on the Hamilton County website. http://www2.hamiltoncounty.in.gov/publicdocs/Campaign%20Finance%20Images/defaultfiles.asp?ARG1=Campaign Finance Images&ARG2=/Brainard, Jim

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