Japan VAD Council,
IMPELLA Committee

Approved products

Product Name: IMPELLA circulatory assist pump catheters
Approval Number: 22800BZI00032000
Approved: as of September 27, 2016

Product Name: IMPELLA controller
Approval Number: 22800BZI00031000
Approved: as of September 27, 2016

Approval conditions

  1. In collaboration with the related societies, the guidelines for the appropriate use shall be established, and necessary measures must be taken to ensure that the product is used by the heart team with sufficient knowledge and experience on the procedures, at medical institutions capable of providing a systematic approach to assisted circulation therapy.
  2. Thorough training must be provided to the heart team to ensure adherence to the guidelines on the appropriate use of the product and to assure safety.
  3. Until a certain number of cases are collected, Post Marketing Surveillance (PMS) must be conducted on all cases in which the product is used; the results of PMS must be reported to the Pharmaceuticals and Medical Devices Agency, and appropriate measures should be taken as necessary.