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OUS Approvals Analysis: BSX, Edwards Score New CE Marks In TAVR Battlefield; Chinese DES Advances In Asia

Executive Summary

September's list of devices approved outside the US include a new transcatheter aortic valve in Europe, two orthopedic devices and a gynecology device in Australia, and a drug-eluting stent in Pakistan.

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EuroPCR 2017: Boston Scientific's Lotus TAVR Beats Medtronic's CoreValve In REPRISE III, But Pacemaker Issue Remains

Boston Scientific's repositionable, mechanically expanded Lotus transcatheter aortic valve performed better than Medtronic's CoreValve for the primary composite effectiveness endpoint in the REPRISE III trial, according to results presented at the EuroPCR meeting in Paris. But the Lotus patients in the trial were more likely to need a pacemaker than the CoreValve patients, a risk that investigators believe can be mitigated with better operator technique.

OUS Approvals Analysis: Small Companies Dominate International Approvals In April

April was a return to a more typical volume of medical device approvals outside the US after a particularly busy March. And the big names in medtech were mostly quiet in April's OUS approvals, according to Medtech Insight's Approval Tracker.

Boston Scientific Pulls All Lotus TAVR Systems Off Shelves

The worldwide voluntary removal comes in response to reports that the pin that connects the valve to the delivery system sometimes releases prematurely, most likely due to excess tension created during manufacturing.

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