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.

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.

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.