Approval for the portico transcatheter aortic valve implantation system. The device is indicated for relief of aortic stenosis in patients with symptomatic heart disease due to severe native calcific aortic stenosis who are judged by a heart team, including a cardiac surgeon, to be at high or greater risk for open surgical therapy (i. E. , predicted risk of surgical mortality >= 8% at 30 days, based on the society of thoracic surgeons (sts) risk score and other clinical comorbidities unmeasured by the sts risk calculator).
|Device||Portico Transcatheter Aortic Valve Implantation System|
|Generic Name||Aortic Valve, Prosthesis, Percutaneously Delivered|
|Applicant Address||Abbott one St. Jude Medical Drive st. Paul, MN 55117|
|Supplement Number||Date||Supplement Type|