LOTUS Edge Valve System
FDA premarket approval P180029 · Aortic valve, prosthesis, percutaneously delivered
PMA numberP180029
Approval
- Applicant
- Boston Scientific Corporation
- Received
- August 14, 2018
- Decision date
- April 23, 2019 (APWD)
- Supplements
- 28, latest March 30, 2021
- Product code
- NPT – Aortic Valve, Prosthesis, Percutaneously Delivered
Approval order statement
Approval for the LOTUS Edge Valve System. The device is indicated for relief of aortic stenosis in patients with symptomatic heart disease due to severe native calcific aortic stenosis (aortic valve area [AVA] of <= 1.0 cm2 or index of <= 0.6 cm2/m2) 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).