TCT 2017: Medtronic touts results from 6-month Evolut Pro study

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 ...
Source: Mass Device - Category: Medical Devices Authors: Tags: Catheters Clinical Trials Replacement Heart Valves Medtronic Source Type: news