St. Jude (STJ) Portico TAVI Moves Closer to Getting CE Mark w/ First Implant Trial
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St. Jude Medical, Inc. (NYSE: STJ), reports the the first implant of its Portico transcatheter aortic valve implant (TAVI) in a European clinical trial to support CE Mark approval. The trial will study the safety and effectiveness of the Portico heart valve for patients with severe symptomatic aortic stenosis (narrowing of the aortic heart valve), who are at high risk for conventional open-heart valve replacement therapy.
The trial is a non-randomized study that will take place at five European centers, and will enroll a minimum of 30 patients who will be followed for one year. The primary endpoint is 30-day all-cause mortality, with secondary safety and effectiveness endpoints. Dr. Ganesh Manoharan of Royal Victoria Hospital in Belfast, U.K. is the principal investigator for the trial.
The trial is a non-randomized study that will take place at five European centers, and will enroll a minimum of 30 patients who will be followed for one year. The primary endpoint is 30-day all-cause mortality, with secondary safety and effectiveness endpoints. Dr. Ganesh Manoharan of Royal Victoria Hospital in Belfast, U.K. is the principal investigator for the trial.
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