St. Jude Medical Pushes Play on Portico Heart Valve Implants Trial
St. Jude Medical (NYSE:STJ), which paused implantations of its Portico replacement heart valve last fall out of an abundance of caution, told MassDevice.com today that European authorities reinstated Portico's CE Mark.
The decision means St. Jude is resuming clinical and commercial implants of the Portico 23mm and 25mm transcatheter aortic valve implants in Europe, spokesman Justin Paquette told us via email.
"We remain in discussions with the FDA to gain approval to resume implants in our U.S. [investigational device exemption trial]," Paquette wrote.
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The decision means St. Jude is resuming clinical and commercial implants of the Portico 23mm and 25mm transcatheter aortic valve implants in Europe, spokesman Justin Paquette told us via email.
"We remain in discussions with the FDA to gain approval to resume implants in our U.S. [investigational device exemption trial]," Paquette wrote.
Help employers find you! Check out all the jobs and post your resume.