Boston Scientific Corporation (NYSE: BSX) announces 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 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 innovative 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 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 Dr. 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, found on the PROMUS Element Stent System and the PROMUS Element Plus Stent System, 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 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 randomized clinical trials and 'real-world' registries, demonstrating excellent long-term safety and efficacy.
"We are proud to introduce the PROMUS Element Plus Stent System to physicians and patients in Europe and other CE Mark countries," said Michael Onuscheck, President, Europe, Middle East and Africa at Boston Scientific. "It is the latest example of Boston Scientific's commitment to market leadership and continued innovation in drug-eluting stents."
The Company received CE Mark approval for the PROMUS Element Stent System in 2009 and for the PROMUS Element Plus Stent System in 2011. In the U.S., the PROMUS Element Plus Stent System was approved by the Food and Drug Administration (FDA) in 2011. The TAXUS® Element Paclitaxel-Eluting Stent System received CE Mark approval in 2010 and is commercialized in the U.S. as the ION™ Paclitaxel-Eluting Stent System, where it received FDA approval in 2011.
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