For the first time since 1994, the FDA’s Center for Devices and Radiologic Health released a draft guidance on Jan. 20 concerning the premarket approval (PMA) and investigational device exemption (IDE) of heart valves.
The FDA defines a replacement heart valve as a “device intended to perform the function of any of the heart’s natural valves,” and gives recommendations to new heart valves such as tissue-engineered valves and polymer leaflet valves.
According to the agency, the guidance applies to percutaneously delivered valves, but not valve-repair devices such as annuloplasty rings or mitral valve repair devices.
Within the documents, the FDA suggested that a risk analysis be performed on these devices including failure modes and risk estimation, evaluation, control and review. The agency recommended these devices undergo clinical trials to measure the significant risks associated with them.
According to the document, the FDA also suggested that a Data Safety Monitoring Board (DSMB) be implemented during clinical investigations. The DSMB should establish specific criteria for the review of adverse events and be equipped with two persons who are either a physician, cardiothoracic surgeon or a cardiologist.
"Based on our long history in the evaluation of heart valves and the extensive reporting in the literature, the FDA believes that a single-arm study with literature-based controls is the least burdensome approach to clinical evaluation of a replacement heart valve," wrote the FDA.
After risk assessments, the FDA recommended that the IDE and PMA applications include clinical trial conditions, sample selections and test reports for the following:
- Material property testing;
- Biological safety;
- Hydrodynamic performance;
- Structural performance;
- Device durability;
- Component fatigue assessments; and
- Device specific testing.
During a controlled study, the FDA suggested that a sample size of 300 or more be used for the first year, and 800 subjects for follow-up.
Interested stakeholders have a 90-day comment period. Comments can be sent to the FDA’s Division of Dockets Management.