It is often said “better late than never”, but any celebrations surrounding yesterday’s US approval of Boston Scientific’s Lotus Edge transcatheter aortic valve are bound to be muted. Investors had been hoping for a mid-2018 launch, but a series of manufacturing and performance issues saw the product recalled from sale in Europe in 2017 and then have its US filing yanked in the same year. The delays to approval have only served to help Boston’s aortic valve rivals Medtronic and Edwards Lifesciences further entrench their leadership positions. And while Lotus Edge has previously demonstrated superiority over Medtronic’s Corevalve in head-to-head trials – beating its rival on the primary efficacy measure of the Reprise III study – 2024 sales forecasts from EvaluateMedTech show that Lotus is destined to remain in third place in this space. Sales of Lotus Edge are likely to be hit further by last month’s readout from the year-long Partner 3 study showing Edwards’ Sapien 3 valve outperformed surgery when it came to aortic stenosis; the result increases the likelihood of Sapien 3, which is currently used in patients with a high risk of death from surgery, replacing surgical valve replacements in low-risk patients.
|Transcatheter aortic valves – the major players|
|WW annual sales ($m)|
|Company||Aortic valve franchise||2018e||2020e||2022e||2024e||CAGR|
|*Note: this also includes revenues from Medtronic's mitral and pulmonary valves.