About the Japan VAD Council, IMPELLA Committee
The Council for Clinical Use of Ventricular Assist Device Related Academic Societies (Japan VAD Council), IMPELLA committee, is comprised of 10 organizations:
- The Japanese Circulation Society (JCS)
- Japanese Association of Cardiovascular Intervention and Therapeutics (CVIT)
- Japanese College of Cardiology (JCC)
- The Japanese Heart Failure Society (JHFS)
- Japanese Society for Artificial Organs (JSAO)
- The Japanese Society of Intensive Care Medicine (JSICM)
- Japanese Society of Pediatric Cardiology and Cardiac Surgery (JSPCCS)
- The Japanese Association for Thoracic Surgery (JATS)
- The Japanese Society for Cardiovascular Surgery (JSCVS)
- Japanese Society of Percutaneous Cardiopulmonary Support / Extracorporeal Membrane Oxygenation (PCPS・ECMO)
… acting together with the goal of safely and effectively disseminating the use of IMPELLA circulatory assist pump catheters in Japan.
By the consensus of the related societies, “The Council for Clinical Use of Ventricular Assist Device Related Academic Societies, IMPELLA committee” was established and the “standards on systems for the appropriate use of IMPELLA, etc.” was developed by this Committee. The Committee certifies facilities based on conditions such as conformity to site requirements and participation in all-patient Registry. In addition, the Committee will utilize the Registry data to promote the appropriate use of IMPELLA through monitoring and verification of cases, as well as provide guidance.
The IMPELLA circulatory assist pump catheter, manufactured by Abiomed, Inc. (herein, the “manufacturer”) was approved on September 27, 2016 under the intended use and the approval condition (approval number: 22800BZI00032000).