Covidien ($COV) is celebrating positive data from two separate trials involving devices designed to treat peripheral artery disease (PAD).
One trial, dubbed DURABILITY II, explored the long-term use of the company's EverFlex self-expanding peripheral stent, which gained a CE mark in January. Covidien said that three-year final results were stellar, with patients who used the stent showing a low need for repeat procedures but also few problems with stent breakage, which can lead to artery reblockage.
The other study, known as DEFINITIVE AR, began in Europe in January 2013 as a randomized test of a combination therapy to prevent arterial narrowing in patients with peripheral artery disease. First, patients had their arterial plaque removed through use of the company's SilverHawk or TurboHawk devices in a process known as directional atherectomy and then faced additional treatment with a drug-coated balloon. Preliminary results from this one are in, and the company notes that the combination is working better than a drug-coated balloon on its own. That involves just 30-day data, but still, it's an encouraging sign. If successful, the concept is designed to improve drug delivery and create a more effective PAD treatment.
Covidien is developing its PAD products with an enormous market in mind. As the company notes, more than 200 million people globally are affected by peripheral artery disease. That means there is plenty of room for multiple treatment options, and Covidien has the resources to make that happen ($9.9 billion in revenue through fiscal 2012 and marketing in more than 140 countries). But Covidien's rivals are rapidly developing their own PAD devices, and competition is intense.
Covidien disclosed the results from both trials at the recent Vascular Interventional Advances 2013 conference in Las Vegas, NV.
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