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Cook Medical gets FDA panel's backing for stent

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Cook Medical Inc., the Bloomington-based maker of devices for minimally invasive medical procedures, won a U.S. panel’s backing for a drug-coated stent to treat blocked femoral arteries.

The benefits of Cook’s device, known as the Zilver PTX, outweigh its risks, outside advisers to the Food and Drug Administration said today in an 11-0 vote, according to an agency spokeswoman.

The 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.

Clinical trials showed the Zilver PTX worked as well as or better than angioplasty and non-medicated stents in unclogging vessels, FDA staff said Oct. 11 in a preliminary review of the product.

The device works by propping open the femoral artery and delivering the cancer drug paclitaxel to the vessel to reduce the risk that fatty deposits will form new blockages.

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.

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

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.

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  1. The east side does have potential...and I have always thought Washington Scare should become an outlet mall. Anyone remember how popular Eastgate was? Well, Indy has no outlet malls, we have to go to Edinburgh for the deep discounts and I don't understand why. Jim is right. We need a few good eastsiders interested in actually making some noise and trying to change the commerce, culture and stereotypes of the East side. Irvington is very progressive and making great strides, why can't the far east side ride on their coat tails to make some changes?

  2. Boston.com has an article from 2010 where they talk about how Interactions moved to Massachusetts in the year prior. http://www.boston.com/business/technology/innoeco/2010/07/interactions_banks_63_million.html The article includes a link back to that Inside Indiana Business press release I linked to earlier, snarkily noting, "Guess this 2006 plan to create 200-plus new jobs in Indiana didn't exactly work out."

  3. I live on the east side and I have read all your comments. a local paper just did an article on Washington square mall with just as many comments and concerns. I am not sure if they are still around, but there was an east side coalition with good intentions to do good things on the east side. And there is a facebook post that called my eastside indy with many old members of the eastside who voice concerns about the east side of the city. We need to come together and not just complain and moan, but come up with actual concrete solutions, because what Dal said is very very true- the eastside could be a goldmine in the right hands. But if anyone is going damn, and change things, it is us eastside residents

  4. Please go back re-read your economics text book and the fine print on the February 2014 CBO report. A minimum wage increase has never resulted in a net job loss...

  5. The GOP at the Statehouse is more interested in PR to keep their majority, than using it to get anything good actually done. The State continues its downward spiral.

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