Royal Philips (NYSE:PHG) said today that third-party data from worldwide clinical trials for the Stellarex drug-coated balloon showed that there was no difference in mortality between patients treated with the device compared to uncoated percutaneous transluminal angioplasty.
The primary analysis consisted of three-year patient-level data from the Illumenate pivotal trial and the Illumenate European randomized controlled trial. Altogether, the trials included 589 patients; 419 of them were treated with Stellarex to attempt to restore and maintain blood flow to arteries in the legs. The other 170 patients were treated with a standard uncoated PTA balloon, according to the analyses that were published in the American Heart Association journal Circulation.
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