Premarket Approval (PMA)

Note: this medical device has supplements. The device description/function or indication may have changed. Be sure to look at the supplements to get an up-to-date information on device changes. The labeling included below is the version at time of approval of the original PMA or panel track supplement and may not represent the most recent labeling.

• Device: LOTUS Edge Valve System
• Generic Name: Aortic valve, prosthesis, percutaneously delivered
• Applicant: Boston Scientific Corporation; 300 Boston Scientific Way; Marlborough, MA 01752-1234
• PMA Number: P180029
• Date Received: 08/14/2018
• Decision Date: 04/23/2019
• Withdrawal Date: 12/13/2021
• Product Code: NPT
• Docket Number: 19M-1998
• Notice Date: 04/26/2019
• Advisory Committee: Cardiovascular
• Clinical Trials: NCT02202434
• Expedited Review Granted?: No
• Combination Product: No
• Recalls: CDRH Recalls

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).

• Approval Order: Approval Order
• Summary: Summary of Safety and Effectiveness
• Labeling: Labeling; Labeling Part 2
• Post-Approval Study: Show Report Schedule and Study Progress
• Supplements: S001 S002 S003 S004 S005 S006 S007 S008 S009 S010 S012 ; S013 S014 S015 S016 S017 S018 S019 S020 S021 S022 S023 S024 ; S025 S026 S027 S028 S030