Boston Scientific announced first patient use and European market launch of the Promus Element Plus everolimus-eluting platinum chromium coronary stent system. The first patient implant in Europe using the new device was performed by Antonio Colombo, director of the Cardiac Catheterization Laboratory at Columbus Hospital and San Raffaele Hospital in Milan, Italy. The new stent system incorporates the platinum chromium (PtCr) alloy and stent design of the Promus Element stent with an enhanced catheter delivery system engineered for improved deliverability in treating patients with coronary artery disease.
“The PtCr alloy and stent architecture used in the Element platform offer significant advantages in conformability and radiopacity compared to other stent platforms,” said Colombo. “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 revascularisation and stent thrombosis at one year.”
The Promus Element Plus stent system employs an advanced low-profile delivery system featuring a dual-layer balloon designed to enable precise stent delivery across challenging lesions and reduce balloon growth during inflation to facilitate high-pressure stent deployment. The everolimus drug and fluorinated copolymer used on the Promus Element stent have been studied in multiple randomised clinical trials and ‘real-world’ registries, demonstrating excellent long-term safety and efficacy.
The Promus Element stent system received CE mark approval in 2009 and the Promus Element Plus stent system in 2011. In the USA, the Promus Element Plus was approved by the Food and Drug Administration (FDA) in November 2011.