Portico TAVR System Found Safe and Effective for High | 合法醫療器材資訊網

October2,2019–TheAbbottPorticoFDAinvestigationaldeviceexemption(IDE)...CaragReceivesU.S.FDAIDEApprovaltoConductClinicalStudyofFirst ...

October 2, 2019 – The Abbott Portico FDA investigational device exemption (IDE) study found that 30-day safety and one-year effectiveness outcomes of a novel self-expanding transcatheter aortic valve replacement (TAVR) system for patients with severe aortic stenosis (AS) at high or extreme-risk for surgery was noninferior to contemporary FDA-approved TAVR systems. Findings were reported at the 2019 Transcatheter Cardiovascular Therapeutics (TCT)[1] scientific symposium.

“Transcatheter aortic valve replacement has fundamentally changed how we approach patient care. Findings from the Portico IDE study have added important new data to the body of TAVR clinical evidence,” said Greg Fontana, M.D.[2], principal investigator. He is director and chairman, cardiothoracic surgery, CardioVascular Institute of Los Robles Regional Medical Center. “By demonstrating results in line with contemporary TAVR systems and an improved delivery system, the Portico valve with FlexNav delivery system...