All device developers run into snags with their hardware, and only some of these issues can be resolved. Boston Scientific has admitted defeat in the case of its Lotus Edge catheter-mounted aortic valve prosthesis, saying today that it was ceasing production of the device and recalling those as yet unused.
Lotus Edge was forecast to be the third biggest-selling transcatheter aortic valve in 2026, and Boston says it will take a hit of up to $300m as a result of canning the programme. In the aortic space Boston is now entirely reliant on Acurate Neo2, recently launched in Europe. But this is not expected to reach the US until 2024, and Boston’s stock is down 10% in early trade.
“We have struggled with the Lotus platform for a number of years,” said Mike Mahoney, Boston’s chief executive officer, on a conference call today, and this was no overstatement: the system used to deliver Lotus Edge has been bedevilled by problems. On the eve of the product’s US launch the group was forced to recall it from the European market, having discovered a fault in the delivery mechanism (No Lotus élan for Boston, February 24, 2017). It was eventually released in the US two years later.
And despite trouncing Medtronic’s aortic valve, CoreValve, in its pivotal study, Lotus failed to set the market on fire. When it was approved in the US in spring 2019, sellside consensus forecast 2024 sales of $1.1bn for Boston’s aortic valve technologies, according to EvaluateMedTech, with Lotus accounting for much of this. Yesterday this figure sat at less than $600m.
Now even those relatively low numbers cannot be realised by Boston. Convinced that developing a better version of the delivery system would not be worth the time and effort, Boston is to “retire” the entire Lotus platform immediately. Because the problem is not with the valve itself, people who have already had one implanted are perfectly fine, but Boston is recalling all unused Lotuses.
Head to head
So that’s that. Now Boston must turn to its other transcatheter aortic implant, Acurate Neo2, the next-generation version of the Acurate Neo valve Boston obtained through the acquisition of Symetis in 2017, just as the problems with Lotus were becoming apparent.
Unfortunately this product has disappointed too. In the Scope II trial which reported last month, the primary endpoint of death or stroke at one year occurred in 16% of patients treated with the first-gen Acurate Neo and 14% of those given Medtronic’s CoreValve Evolut. It thus missed the benchmark for noninferiority with a p value of 0.0549.
This delayed the expected US launch of Acurate Neo2 from next year to 2024, though the EU launch had already got under way. Neo2 is currently in a 600-patient US clinical trial, Acurate IDE, comparing it with both CoreValve and Edwards Lifesciences’ market-leading Sapien. Results could emerge next year.
Boston said on today’s call that shuttering Lotus might enable it to reallocate resources to the Acurate Neo2 programme, potentially speeding the approval timeline up; however, there is always a risk that Covid-19 could negatively affect enrolment, negating any gains.
The Acurate franchise is, it turns out, already outpacing Lotus. “Truth be told … in calendar year 2020 we will sell more Acurate and Acurate Neo2 in Europe than we did Lotus globally,” Mr Mahoney said. This is in contrast to most analysts’ forecasts, which had seen Acurate Neo2 coming second to Lotus for the next few years at least.
Perhaps Neo2 can rescue Boston’s status as a transcalther aortic valve player. But it will need to score a convincing hit in Acurate IDE. Going head-to-head with both CoreValve and Sapien – the latter is widely considered the best and safest device of its kind on the market – will be a tough test.