Boston Scientific (BSX) Hits the Pause Button on Next-Generation Lotus Edge Replacement Heart Valve in Europe
11/1/2016 8:01:00 AM
Boston Scientific is reportedly pausing implantations of its next-generation Lotus Edge replacement heart valve in Europe to investigate a locking mechanism issue.
Marlborough, Mass.-based Boston Scientific has implanted about 200 of the Lotus Edge transcatheter aortic valve replacements in Europe, according to Barclays analyst Matthew Taylor, encountering about a 4% rate of “some issues with [the] locking mechanism of the valve.”
“In these cases (incidence rate of ~4%), the device was recaptured and a new valve was implanted with no major adverse events,” Taylor wrote today in a note to investors.
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