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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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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.
 
DeviceLOTUS Edge Valve System
Classification Nameaortic valve, prosthesis, percutaneously delivered
Generic Nameaortic valve, prosthesis, percutaneously delivered
Applicant
Boston Scientific Corporation
300 boston scientific way
marlborough, MA 01752-1234
PMA NumberP180029
Date Received08/14/2018
Decision Date04/23/2019
Product Code
NPT[ Registered Establishments with NPT ]
Docket Number 19M-1998
Notice Date 04/26/2019
Advisory Committee Cardiovascular
Clinical Trials NCT02202434
Expedited Review Granted? No
Combination Product No
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 StudyShow Report Schedule and Study Progress
Supplements: S001 S002 S004 S005 S006 S007 S009 S010 S012 
S013 S014 S015 
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