After the slam-dunk data on MitraClip presented at TCT in 2018 Abbott is poised to lead the market for mitral valve repair technologies for years to come. Edwards Lifesciences, however, is fighting back, and yesterday added a second string to its bow with European approval of the Pascal system. This is forecast to sell better than Cardioband, a different mitral repair technology that Edwards had acquired from Valtech Cardio in late 2016, despite Cardioband having been approved in Europe three years ago – the latter has been beset by difficulties in scaling up production. Both Edwards’ devices are in pivotal US trials. The Clasp IID study of Pascal in degenerative or primary mitral regurgitation will report in 2021, and a study in functional or secondary MR is due to start this year. Cardioband’s pivotal US trial, Active, is on hold, however, so Edwards can reassess the protocol. MitraClip, approved by the FDA in 2013, will have the US market to itself for the foreseeable future, and carries forecast global sales of nearly $1.8bn in 2024.
|Selected transcatheter mitral valve repair devices|