Promus Element, Promus Element Plus Receive CE Mark Approval For Labeling Update

Boston Scientific Corp. (BSX) said it has received approval to update the directions for use or DFU labeling for Promus Element and Promus Element Plus Coronary Stent Systems to include three-month Dual Anti-Platelet Therapy or DAPT. This outlines a minimum duration of three months of DAPT for certain patients who may need to interrupt or discontinue the medication for a variety of reasons and supports the strong safety profile for Promus Element and Promus Element Plus Stents. The label change will be introduced in CE Mark countries.

"This update to our labeling highlights that the need still exists for a drug-eluting stent that reduces the risks associated with long-term durable polymer exposure. We believe our next generation SYNERGY Stent, with its unique PLGA bioabsorbable polymer, will address that need," said Kevin Ballinger, president of the Interventional Cardiology Division at Boston Scientific.

The Synergy Stent is unique in that its proprietary PLGA polymer and everolimus drug coating dissipate by three months. The company noted that the simultaneous drug and polymer absorption is designed to encourage optimal healing, eliminate long-term polymer exposure and potentially lead to reduced long-term events, such as very late stent thrombosis.

The Synergy Stent is an investigational device, limited by law to investigational use and is not approved or available for sale in the United States and the European Economic Area.

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