Boston Scientific (NYSE:BSX) 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.
The company pulled Lotus Edge from the market in Europe, where it won CE Mark approval last month, so it can figure out the problem.
“Boston Scientific is initiating a voluntary removal of field inventory of the Lotus Edge valve system. During the initial launch to a limited number of European sites, we received reports that in some cases the device could not be fully locked and therefore the procedure could not be completed. In all cases, patients were successfully treated with a new valve,” the company told MassDevice.com in an emailed statement. “This action does not impact patients who have already been implanted with the device. The company is completing an evaluation to identify the root cause of the issue. Physicians are advised to use the previous generation Lotus valve system, which continues to be available in Europe.”
“BSX does not think that correcting Edge will require a valve redesign, but having made this decision [Oct. 28], cannot answer the question as to when it will be back in the market with precision. It does not anticipate that this will change any timelines or financial guidance including the Reprise trials or launch of Lotus in the U.S,” Taylor wrote.
Yesterday at the annual Transcatheter Cardiovascular Therapies conference in Washington, D.C., Dr. Ian Meredith (who’s slated to replace chief medical officer Dr. Keith Dawkins next year) presented feasibility data on 21 patients treated with the Lotus Edge device, showing 100% technical success, no or only trace paravalvular leakage and a 4.8% stroke rate, a 9.5% rate of new pacemaker implantation and no repeat procedures.
“The company believes it has something very differentiated; it would not comment on pricing strategy but said that looking at major medtech markets where there are three 3 share players that split the market is illustrative. It would be disappointed with 5% to 10% share given the talent and investment that it is putting in the market and expects to be a leader in the [TAVR] space,” Taylor wrote. “Dr. Dawkins noted increased confidence that BSX can be competitive with 2nd-generation valves on pacer rates, driven by changes in technique and technology. Further, BSX outlined plans for its intermediate- and low-risk trials (Reprise IV and V) which will start in 2017; Reprise IV will randomize versus EW’s S3 and Reprise V will go against surgery.”
