February 1, 2012 — Boston Scientific announced the first patient use and European market launch of the Promus Element Plus everolimus-eluting coronary stent system. The first patient implant in Europe using the new device was performed by Professor Antonio Colombo, M.D., 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 with a catheter delivery system engineered for improved deliverability in treating patients with coronary artery disease. The company plans to begin marketing the product in select European and other CE mark countries immediately and will expand to a full market launch in the second quarter.
"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 revascularization and stent thrombosis at one year."
The Promus Element stent uses a proprietary PtCr alloy designed specifically for coronary stenting, which enables enhanced visibility, less recoil, excellent conformability and higher radial strength. The Promus Element Plus stent 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 randomized clinical trials and real-world registries, demonstrating excellent long-term safety and efficacy.
The company received CE mark approval for the Promus Element in 2009 and for the Promus Element Plus in 2011. In the United States, the Promus Element Plus was approved by the U.S. Food and Drug Administration (FDA) in 2011. The Taxus Element paclitaxel-eluting stent received CE mark approval in 2010 and is commercialized in the United States as the Ion paclitaxel-eluting stent, where it received FDA approval in 2011.
For more information: www.bostonscientific.com