WG2 - Postmarket Registries (e.g., artificial heart)
Working Group 2 was tasked by the HBD Steering Committee to focus on the post-market issues related to mechanical circulatory support devices (MCSDs). Post-market information provides feedback to clinicians, manufacturers, and regulatory agencies regarding the safety and effectiveness of devices after commercialization. This concept paper will provide information on the mission and activities of WG2 as identified by its members.
MCSDs have been approved for patients with advanced heart failure in Japan and in the United States. Most of these MCSDs require a post-approval study to monitor the commercial use of those devices when used in the real world. In Japan, this post-approval study process is also known as re-examination or reevaluation. One burden for manufacturers regarding post-approval studies is the additional funding needed to perform these studies. Recently, a joint effort involving the National Heart Lung and Blood Institute (NHLBI), Centers for Medicare and Medicaid Services (CMS), FDA, clinicians, scientists, and industry resulted in the development of the Interagency Registry for Mechanically Assisted Circulatory Support (INTERMACS).
The INTERMACS registry will capture the performance of implanted mechanical cardiac support systems to provide information regarding their precise role in the management of heart failure both long-term (destination) and short term (bridging) based on robust safety and effectiveness data. This national registry will also collect data anticipated to facilitate improvement of patient management, aid device development, and encourage innovative clinical trial designs for future MCSDs. INTERMACS can provide manufacturers a cost effective and least burdensome way to conduct post-market studies and government regulatory agencies a robust mechanism for reviewing these studies.
The mission of WG2 is to facilitate multilevel discussion and collaboration on policy between Japanese and US institutions regarding the application of MCSD technology. This mission envisages incorporating global monitoring of devices postmarket that will incorporate Japanese data with that of the US in the INTERMACS registry. Similarly, a Japanese INTERMACS will allow MHLW/PMDA to perform re-evaluation/re-examination of MCSDs approved in Japan. Such collaboration also offers an opportunity for generating data, objective performance controls or goals, that when applied for clinical trial design will be globally acceptable. It is hoped that with the combined efforts by MHLW-PMDA, FDA, INTERMACS, and HBD, we can identify and eliminate existing barriers to future approvals of MCSDs as well as identify best medical practices that will ensure the safe use of MCSDs in appropriate patient populations in the expanding realm of advanced heart failure.
The specific aims are:
- To identify key factors necessary to incorporate Japanese MCSD data into INTERMACS
- Identify how manufacturers can fulfill post-market requirements or reevaluation requirements in Japan and in the US through INTERMACS
- Identify mechanisms for the development of objective performance criteria or matched control datasets from registries
- To report information to the HBD Steering Committee and other HBD working groups that maybe working on shared issues (i.e., WG4 – regulatory convergence and communication)
- MHLW/PMDA is interested in the concept of INTERMACS and believes that the development of a Japanese INTERMACS is necessary. Pharmaceutical and medical devices safety office of PMDA likes this concept and is onboard.
- Provide adverse event definitions and data collection parameters to Japanese regulatory officials to determine if that information is acceptable
- Describe the similarities and differences in the regulatory practices involved in post-market re-examination or reevaluation of medical devices
- Identify problems that may arise in trying to incorporate Japanese MCSD data into INTERMACS
The membership for WG2 encompasses the general principles of HBD for symmetry, balance, and transparency between Japan and the US. The membership includes individuals from the regulatory agencies, academia, industry, and other interested parties.
The chairmanship of WG2 will be held jointly by designated representatives from the FDA and Japanese academia. Mr. Eric Chen from the FDA, Dr. Kazuhiro Sase from the Juntendo University Hospital, and Dr. Takeshi Nakatani from the National Cardiovascular Center will chair WG2. Chairmanship by these three individuals is justified by their experience in the regulatory field and because of their relationships within the MCSDs community in their respective countries.
Possible Regulatory Target Areas
Possible regulatory target areas for examination include:
- Types of information that is required in a post-market or re-examination report
The future plans of WG2 include the following:
- Finalize the WG2 concept paper and obtain approval from the HBD Steering Committee
- Determine the appropriate data elements to be collected in Japanese INTERMACS
- Participate at International Society of Heart and Lung Transplantation conference in 2008
- Discuss the similarities and differences in the regulatory process for post-market or re-examination of MCSDs
- Formulate recommendations to accomplish the aims of WG2
- Obtain inputs on future work to be presented at HBD East 2008 meeting
Updated April 15, 2008