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News Briefs: Boston Sci’s DES Approval; Bard’s Drug-Coated Balloon Submission

This article was originally published in The Gray Sheet

Executive Summary

Product approvals from Boston Scientific, Bruker and Sorin. Bard completes drug-coated balloon PMA. HHS OIG amends Synthes corporate integrity agreement.

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New Product Briefs: Devices From Medtronic, Sorin, Smith & Nephew

New product approvals and launches announced this week include a new sinus dilation system and cervical disc from Medtronic, an aortic valve with a novel removable stent from Sorin, and a toe-repair device from Smith & Nephew.

Research Briefs: Studies From Exact Sciences, EndoChoice; Neuroimaging Overuse

In the lead up to an FDA panel, positive data is published for Exact Science’s Cologuard multi-target stool DNA-based screening test. EndoChoice’s Fuse endoscope sees more colon cancer than traditional endoscopes. Overuse of neuroimaging for headaches documented. Long-term study finds high-frequency oscillatory ventilation is better for premature babies than standard ventilation. Drug-coated balloon trial.

Bard’s Lutonix Drug-Coated Balloon Shows Efficacy In Early Trial Results

Six-month data from the rigorous Levant 2 trial, presented at the TCT conference in San Francisco, show peripheral angioplasty with Bard’s Lutonix paclitaxel-coated balloon reduces restenosis compared with regular balloon angioplasty. The findings give the company an edge in the race to be the first on the U.S. market with a drug-coated peripheral angioplasty balloon.

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