Of all the products Boston Scientific has in its pipeline, the Lotus Edge transcatheter aortic valve (TAVR) may be one of the most watched. Recent management commentary indicates that timelines are moving forward smoothly on that device.
On Boston Scientific's February 2 earnings call, company management offered an update on the Lotus Edge, a device that has drawn interest from the medical and analyst community because the current generation device, Lotus TAVR, is known for having low rates of the side effect paravalvular leak (PVL). The Lotus Edge has been described as being designed to maintain those low PVL rates while also reducing permanent pacemaker implant rates with its Depth Guard technology.
Commercial implants of the Lotus Edge, which has CE Mark, were voluntarily halted last fall after a locking issue with one pin of the valve's commissure was observed in 7 of approximately 200 commercial patients (4%). Boston Scientific's management said at the time that a redesign of the valve was not necessary and has since reiterated that this would not delay its Lotus Edge timeline.
Management again told analysts that they expect to file a PMA for Lotus Edge in the second quarter and anticipate FDA approval by the end of 2017.
According to a Seeking Alpha transcript of the earnings call, Michael Mahoney, Boston Scientific chairman and CEO, said, "We do expect to launch in the US with LOTUS Edge. We're optimistic that we'll have approval by year end of 2017."
In addition, the device is anticipated to launch in Europe in the third quarter. Mahoney noted that third quarter goal while emphasizing, "our current Lotus platform is doing extremely well in Europe." He added, "You talk to many physicians and they certainly want Lotus Edge, but they're very happy with Lotus and its current capabilities, its ability to position the device, low PVL rate. So, we want to launch Lotus Edge, but we're more than pleased with the growth of our current Lotus platform."
A slew of data on Lotus and Lotus Edge is expected over the next several months. Thirty-day data on the first-in-human use of the Lotus Edge will be shown at the American College of Cardiology (ACC) conference in Washington in March. At the EuroPCR meeting in Paris this May, data from the RESPOND extension study on Lotus with Depth Guard as well as the REPRISE III pivotal trial and the REPRISE Edge study are slated for presentation.
When asked about reasons for optimism on a potentially lower pacemaker implant rate, Ian Meredith, AM, Boston Scientific's global chief medical officer, pointed to the upcoming data. He noted broader adoption of a change in the depth of implantation, "meaningful data" at EuroPCR on the Lotus with Depth Guard technology, extended data from the first-in-human study on Lotus Edge, and the EuroPCR data on REPRISE Edge.
"So there are four streams of evidence that seem to be moving in the right direction," Meredith said. "The technique for implantation I think has been widely adopted already. And that sets a very strong foundation for people's ability to use Depth Guard when they move to Lotus Edge."
That means all eyes are on the data coming out this spring--stay tuned.
[Image courtesy of BOSTON SCIENTIFIC CORP.]