Regulatory Decision Summary for Lotus Valve System

Review decision

The Regulatory Decision Summary explains Health Canada’s decision for the product seeking market authorization. The Regulatory Decision Summary includes the purpose of the submission and the reason for the decision.


Product type:

Drug

Summary of Withdrawal or Refusal due to Non-response Lotus Valve System

Medicinal ingredient(s):

Therapeutic area:

Type of submission:

Control number:

Overview

What was the application for at the time of decision?

This was a class IV application for a new medical device licence for the Lotus Transcatheter Aortic Valve Implantation system. The Lotus Valve System is intended to improve the aortic valve function for symptomatic patients with severe calcific aortic stenosis (aortic valve area [AVA] of < 1.0 cm2 or index of < 0.6 cm2/m2) who are at high risk for standard surgical valve replacement.

Outcome of application

Withdrawn by manufacturer during the review and prior to issuance of a decision by Health Canada

Date of decision:

2017-03-22

Manufacturer:

Boston Scientific Corporation

Drug Identification Numbers issued:

    Prescription status:

    Date filed:

    2016-06-30

    Contact:

    Medical Devices Bureau
    Date modified: