UK regulator asks cardiologists to report adverse effects of heart deviceBMJ 2012; 344 doi: https://doi.org/10.1136/bmj.e2194 (Published 21 March 2012) Cite this as: BMJ 2012;344:e2194
- Clare Dyer
The UK regulator of medical devices has written to all interventional cardiology units to ask for reports on any adverse effects in patients who had a device fitted to close a patent foramen ovale in their hearts.
Around one in four of the population is thought to have this type of heart defect, which is believed to increase the risk of stroke through a phenomenon known as paradoxical embolism. Devices to close a patent foramen ovale have been widely used to try to prevent these strokes, although evidence for the intervention has been scant.
The decision by the Medicines and Healthcare Products Regulatory Agency (MHRA) to call for adverse effect reports has come as a randomised trial to compare the use of one type of device, the STARflex, with medical treatment alone found no significant difference between the two in the prevention of stroke or transient ischaemic attack among people with evidence of a …