LOTUS Edge Valve System

FDA premarket approval P180029 · decided 2019-04-23

Approval details

PMA number

P180029

Trade name

LOTUS Edge Valve System

Generic name

Aortic valve, prosthesis, percutaneously delivered

Applicant

Boston Scientific Corporation

Date received

2018-08-14

Decision date

2019-04-23

Days to decision

252 days

Decision code

APWD

Product code

NPT

Advisory committee

Cardiovascular

Expedited review

No

Location

Marborough, MA

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 c

510(k) clearances by this applicant