Investigators evaluated the Acurate neo2 open-cell, supra-annular, self-expanding transcatheter aortic valve replacement (TAVR) in the ACURATE-IDE randomized trial. The valve is commercially available in more than 50 countries but hasn’t been evaluated in a randomized trial until ACURATE-IDE. It aims to prospectively evaluate the safety and efficacy of the valve compared to commercially available options in treating severe symptomatic aortic stenosis.
The study compared Acurate neo2 to the Edwards Sapien 3 (or Sapien 3 Ultra) or Medtronic Evolut.
According to the study’s abstract in The Lancet, TAVR with Acurate neo2 failed to meet non-inferiority. It also resulted in “significantly worse outcomes with respect to the primary endpoint.” That endpoint constituted a composite of all-cause mortality, all stroke and rehospitalization at one year.
This data publication comes about seven months after Boston Scientific announced that a study Acurate neo2 missed its primary endpoint in ACURATE-IDE. At the time, Needham analyst Mike Matson wrote: “It’s unclear what this means for FDA approval of ACCURATE neo2, but we think approval is less likely, and some sort of additional clinical data may be required.”
ACURATE-IDE recruited 1,500 patients (median age of 79 years) between June 10, 2019, and April 19, 2023. Of that population, investigators randomly assigned 752 to the Acurate neo2 group and 748 to control.
The Boston Scientific study remains ongoing.
