Medtronic has released new late-breaking data from the CoreValve Evolut Clinical Program, supporting the use of its CoreValve/Evolut transcatheter aortic valve replacement (TAVR) System.
The data included a secondary analysis of the SMall Annuli Randomized To Evolut or SAPIEN (SMART) Trial of Evolut TAV across the entire range of small annulus areas against the Edwards Sapien 3 TAV platform.
It also included CoreValve-Evolut pooled analysis of bioprosthetic valve dysfunction (BVD) outcomes in comparison to surgery.
The CoreValve and the latest Evolut TAVR systems are used in treating patients with symptomatic severe aortic stenosis (AS) through TAVR procedures.
The SMART Trial revealed that patients of all annular sizes who underwent Evolut self-expanding valve (SEV) implantation experienced lower rates of BVD compared to those who received the Edwards Sapien balloon-expandable valve (BEV) over one year.
Additionally, the study showcased non-inferior clinical outcomes. These included a lower composite rate of all-cause mortality, disabling stroke, or heart failure rehospitalisation, and superior valve performance in SEV against BEV.
On the other hand, expanded data from a combined CoreValve-Evolut analysis revealed superior five-year valve performance.
The assessment was done on patients with symptomatic severe AS undergoing TAVR with Medtronic’s valve compared to conventional surgery.
Additionally, the findings indicated a reduced risk of BVD for patients with both small and large annuli who received the Evolut valve in comparison to surgery.
Medtronic said that this study is the first to evaluate the validity of clinical criteria for assessing valve function using a modern, comprehensive definition of BVD.
Previously, the medical technology firm expanded this pooled analysis to include a more thorough dataset including additional valve reinterventions, valve-related deaths, and unscheduled echoes.
Medtronic cardiovascular portfolio structural heart and aortic business senior vice president and president Nina Goodheart said: “The late-breaking findings presented at New York Valves build on the proven valve performance and durability legacy for the CoreValve/Evolut System.
“We know how important valve performance and durability are when clinicians are seeking a TAVR product that is not only safe, but also reduces the risk of rehospitalisation and mortality.”
