The UK’s Medicines and Healthcare products Regulatory Agency today published a notice warning of an increased risk of early structural valve deterioration in select LivaNova (NSDQ:LIVN) Mitroflow LX pericardial aortic heart valves.
The alert applies only to Mitroflow LX model valves marketed in the UK between 2005 and 2014, and indicates that patients implanted with the smaller sizes of the valve are prone to early SVD.
The MHRA said it estates that less than 80 of the small sized valves were sold in the UK over the past 5 years, and that the number of affected patients is expected to be “comparatively low”.
The agency recommended that healthcare specialists identify patients implanted with smaller sizes, undertake early clinical reviews and investigate for any early SVD and intervene if necessary. The group also requested that any incidents of failure be reported.
The regulatory body said that the manufacturer “is planning a targeted, post-market surveillance study in the UK to compare Mitroflow with all-comers, including the use of other scented tissue valves that require ancillary procedures such as aortic root enlargement,” according to the release.