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New Products In Brief

A drug-eluting stent and prostate cancer assay are among newly approved devices.

The company announced Feb. 17 the immediate U.S. launch of its Resolute Integrityzotarolimus-eluting coronary stent following PMA approval. It is the first FDA-approved drug-eluting stent indicated to treat patients with coronary artery disease who also have diabetes, Medtronic PLC says. The device incorporates the MicroTracdelivery system and continuous sinusoid technology to offer improved deliverability and conformability while retaining the same drug and BioLinx polymer of the original Resolute drug-eluting stent. Its approval stems from the results of a global series of studies, the firm notes, including the 1,402-patient RESOLUTE US trial, which showed low rates of target lesion failure (4.7%) and clinically-driven target lesion revascularization (2.8%) at one year of follow-up. The stent was CE-marked in 2010. (See [A#01360360026_b].)

Gen-Probe Inc.announced PMA approval Feb. 15 for its Progensa PCA3urine-based molecular diagnostic to help determine the need for repeat prostate biopsies in men suspected of having prostate cancer. The...

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