Medtronic (NYSE:MDT) today released six-month data from a study of its Evolut Pro transcatheter aortic valve replacement platform, touting low rates of paravalvular leaks and low rates of all-cause mortality and disabling stroke.
Data came from 60 patients in the trial who received the Evolut Pro valve, and follow previously released 30-day outcomes.
Results at six-months indicated trace or no paravalvular leaks in 88% of patients, with low rates of all-cause mortality and disabling stroke. No instances of coronary obstruction or valve thrombosis were reported and the permanent pacemaker implantation rate was 11.7%, Medtronic said.
“These latest six-month results suggest that the Evolut PRO valve, with its self-expanding nitinol frame and outer pericardial tissue wrap, maintains a very low incidence of paravalvular leak. It is encouraging to observe the sustained low rates of PVL over time combined with exceptional hemodynamics, while maintaining a low rate of new pacemaker implants,” Dr. John Forrest of the Yale New Haven Hospital said in a press release.
The Fridley, Minn.-based company also released data from the STS/ACC TVT registry which compared patients at high surgical risk with bicuspid aortic valve disease to those with severe tricuspid aorctive valve disease, treated with its Evolut R system, in real-world clinical practices.
Outcomes at 30 days were similar between both groups, though the bicuspid had lower rates of all-cause mortality at 2.2% and 3.2% respectively, stroke at 2.6% and 3.4% respectively and major vascular complications at 0.5% and 1.6% respectively. Hemodynamic outcomes were also similar between groups, which showed symptomatic improvement over time.
“The results from this large, real-world analysis are promising indicators for new patient populations in the future. We look forward to further study and evaluation,” Dr. Jeffrey Popma of Boston’s Beth Israel Deaconess Medical Center said in a press release.
Medtronic said it plans to launch a new study of its Evolut Pro TAVR in patients with bicuspid aortic valve disease.
Yesterday, Medtronic released 30-day results from the pilot study of its Intrepid transcatheter mitral valve replacement system, touting procedural success and reductions in mitral regurgitation from the 1st 50 consecutive patients in the trial.