Edwards Lifesciences has voluntarily implemented a temporary pause on enrolment in its Fortis clinical programme, in consultation with trial investigators. A company press release states that it observed evidence of valve thrombosis that it believes warrants additional investigation.
The company says it is “working closely with the trial investigators and heart teams to gather additional information in this early study of transcatheter mitral valve replacement therapy.”
To date, more than 20 patients have been treated globally with the Fortis valve, all of whom had symptomatic mitral regurgitation and who were either compassionate cases or in one of our high-risk registries.
“While it is still very early in the programme, and we anticipated that optimising this therapy would be challenging, we are continuing to learn which patients may benefit. We remain committed to and are encouraged by the early experience in transcatheter mitral valve replacement therapy”, the company stated.
The Fortis valve is not approved for sale in any country.