Boston Scientific's Promus Element Plus Launched in Europe

February 1, 2012—Boston Scientific Corporation (Natick, MA) announced the European market launch of the Promus Element Plus everolimus-eluting platinum chromium (PtCr) coronary stent system.

The company plans to begin marketing the device in select European and other CE Mark countries immediately and will expand to a full market launch in the second quarter of this year. The Promus Element Plus stent system received CE Mark approval and US Food and Drug Administration approval in 2011.

According to Boston Scientific, the device's PtCr alloy is specifically designed for coronary stenting to enhance visibility, lessen recoil, provide conformability, and increase radial strength.

The low-profile delivery system features a dual-layer balloon to enable precise stent delivery across challenging lesions and reduces balloon growth during inflation to facilitate high-pressure stent deployment. The everolimus drug and fluorinated copolymer used on the device have demonstrated long-term safety and efficacy in multiple randomized clinical trials and real-world registries, stated the company.

"The PtCr alloy and stent architecture used in the Element platform offer significant advantages in conformability and radiopacity compared to other stent platforms," commented Prof. Antonio Colombo, MD, who performed the first procedure using the device in Europe. "I believe the improved deliverability of the Promus Element Plus stent system will add another significant benefit, especially when accessing challenging lesions. This innovative stent is also supported by strong clinical outcomes from the PLATINUM trials, which demonstrated very low rates of revascularization and stent thrombosis at 1 year."