Covidien Plc. (NYSE:COV) enrolled the first patients into its two Iliac stent trials, Durability and Visibility.
The trials will each enroll 75 patients at up 20 centers in Europe and the U.S. in order to test the safety and effectiveness of Mansfield, Mass.-based Covidien’s Iliac stent systems for patients with peripheral arterial disease.
Both studies have started in Belgium, enrolling patients at AZ St-Blasius in Dendermonde and Imelda Hospital in Bonheiden.
Covidien ranked 9th on the MassDevice Big 100 list of the world’s largest medical device companies.
The Durability trial will test the Protege EverFlex self-expanding stent with delivery technology, and the Visibility study will test the Visi-Pro balloon expandable stent systems.
Visi-Pro and Protege are already available in the U.S. as treatments for malignant neoplasts in the biliary tree, according to the press release, but the studies hope to expand the indications to PAD treatment in the iliac arteries.
Listen to our exclusive podcast of MassDevice publisher Brian Johnson’s intimate interview with Covidien CEO Joe Almeida.
Here’s a roundup of recent clinical trial and scientific study news:
The next generation of artificial lungs may be able to use air instead of pure oxygen that current man-made lungs require, according to researchers at Case Western Reserve University in Cleveland, Ohio. The device is still years away from human use, but researchers say that by the time it’s ready it’ll only be about the size of a human lung, or around 6 inches by 6 inches by 4 inches.
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Biotronik AG has been busy with trials in the last month, announcing closed enrollment of its 4Ever study and opening enrollment for its BioFlow II study. The 4Ever study enrolled 120 patients into a physician-initiated trial of the Switzerland-based company’s Astron Pulsar and Pulsar-18 stents in treatment of superficial femoral artery lesions. The stent trial will study about 440 patients to compare Biotronik’s Orsiro drug-eluting stent to Abbott’s (NYSE:ABT) Xience Prime stent.
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Left ventricular assist devices led to better quality of life in patients over the age of 70, according to a study published in the June issue of the
Journal of the American College of Cardiology. Patients were implanted with Thoratec Corp.’s (NSDQ:THOR) HeartMate II LVAD, which won FDA clearance in April 2008.
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