Commercial name: Aortic Valve Prosthesis Pre-assembled Transcatheter in the Introducer System - LotusTM Valve - ANVISA registration number: 10341350785 - Risk class: IV - Maximum risk - Model affected: All. Serial number affected: All 의 안전성 경고

Brazilian data is current through June 2018. All of the data comes from Anvisa, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of data from the U.S. and Brazil.

Boston Scientific of Brazil informs that for the unit to be designated as independent, it should have completed the following: 1. Two doctors must be certified. To do so, they must have: a. Participated in face-to-face training; B. Performed at least 6 Lotus Valve procedures with a Prospective and Clinical Field Expert (FSC) from Boston Scientific; or performed at least 4 additional Lotus Valve procedures with a Boston Scientific Field Clinical Specialist (FSC). 2. Two members of the cath lab should be certified to prepare the Lotus Valve; 3. Certified physicians must be trained in Advanced Techniques by Boston Scientific of Brazil. If the unit is not independent, procedures should not be performed with the Lotus Valve without the support of a Boston Scientific Field Clinical Specialist (FSC).