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|Medtronic Evolut(TM) PRO TAVR System with Advanced Sealing Maintains Excellent Outcomes Over Time|
Evolut PRO Valve Well-Positioned for Future with New Study Unveiled to Investigate Expanded Patient Population
DUBLIN and DENVER - November 2, 2017 - Medtronic plc (NYSE:MDT) today presented new data at the Transcatheter Cardiovascular Therapeutics (TCT) Annual Meeting showcasing the excellent clinical performance of the Evolut(TM) Transcatheter Aortic Valve Replacement (TAVR) platform. Six-month data from the newest-generation Evolut PRO System demonstrated continued benefits of its unique valve design. Results from the STS/ACC TVT Registry with the Evolut R in patients with bicuspid aortic valve disease were also presented.
Evolut PRO 6-Month Outcomes
"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," said John Forrest, M.D., director of interventional cardiology at Yale New Haven Hospital in New Haven, Conn. "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."
STS/ACC TVT Registry Bicuspid Data
At 30-days, clinical outcomes were similar for the bicuspid group compared to the tricuspid group with lower rates of all-cause mortality (2.2 percent vs. 3.2 percent), stroke (2.6 percent vs. 3.4 percent) and major vascular complications (0.5 percent vs. 1.6 percent). Additionally, hemodynamic outcomes were similar between the groups with both patient populations showing a symptomatic improvement over time.
"The results from this large, real-world analysis are promising indicators for new patient populations in the future," said Jeffrey J. Popma, M.D., director of Interventional Cardiology at the Beth Israel Deaconess Medical Center, Boston, Mass. "We look forward to further study and evaluation."
To further support TAVR clinical evidence for the treatment of bicuspid patients, Medtronic announced plans to conduct a new study in a bicuspid patient population. The study will utilize the Evolut PRO TAVR system.
The CoreValve Evolut TAVR platform consists of the CoreValve, CoreValve Evolut R and the CoreValve Evolut PRO systems, all of which have received CE mark and FDA approval for use in severe aortic stenosis patients at an intermediate surgical risk or greater.
Any forward-looking statements are subject to risks and uncertainties such as those described in Medtronic's periodic reports on file with the Securities and Exchange Commission. Actual results may differ materially from anticipated results.