Boston Scientific to update EU Promus Element stent labelling

Boston Scientific has received regulatory approval for updated labelling for a pair of coronary stent systems.

The Promus Element and Promus Element Plus will receive a CE Mark-approved label change to recommend a minimum duration of three months of dual anti-platelet therapy (DAPT) for certain patients who may need to interrupt or discontinue the medication for a variety of reasons.

Moreover, the update also supports the strong safety profile offered by the devices, both of which have had their efficacy confirmed in clinical trials.

Boston Scientific noted that this update underlines the need for a drug-eluting stent that reduces the risks associated with long-term durable polymer exposure, adding that its new Synergy stent could fill this niche.

Dr Keith Dawkins, executive vice-president and global chief medical officer for Boston Scientific, said: "Boston Scientific is pleased to provide this additional guidance in our labelling. However, it remains important to consider the major clinical society guidelines for DAPT post-stent implantation for durable polymer stents."

Last week, the company reported positive clinical data from a study of its self-expanding nitinol stent system Epic, demonstrating its efficacy over a 12-month period.