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The US Food and Drug Administration (FDA) has cleared Boston Scientific’s new 32mm and 38mm length Promus Element Plus everolimus-eluting platinum chromium coronary stent systems.
The Promus Element stent uses a proprietary platinum chromium alloy alongside the everolimus drug, and is designed for the treatment of patients with coronary artery disease .
The FDA approval is based on one year positive data from a prospective, multicentre, single-arm Platinum Long Lesion trial, which is part of the Platinum clinical trial programme.
The Platinum Long Lesion trial was designed to assess the safety and effectiveness of the Promus Element stent for the treatment of de novo coronary lesions greater than 24mm to less than or equal to 34mm in length.
Northern Michigan Regional Hospital heart and vascular institute programme director Louis Cannon, who has used the stents in the Platinum clinical trial, said that the evidence from the Platinum trials documents the safety and efficacy of the Promus Element Plus stent system, including extremely low rates of stent thrombosis.
"The impressive patient outcomes achieved with the Promus Element Plus stent system in clinical study and in day-to-day practice are especially relevant when treating patients with long lesions, which are often challenging cases representing complex diseases," Cannon added.
"What’s more, we’re achieving these results with a highly deliverable stent system that features stents of unparalleled radial strength, conformability and visibility."
Boston Scientific cardiovascular division president Kevin Ballinger said: "We continue to secure regulatory approvals and introduce the breakthrough Promus Element Plus stent system, now available in the US and the EU."
The Promus Element Plus stent system received CE Mark approval in 2011.
In addition to the Promus Element Plus stent system, Boston Scientific provides the Omega bare-metal stent system and the Taxus Element paclitaxel-eluting stent system.
Image: Boston Scientific’s corporate headquarters in Massachusetts, US. Photo courtesy of: Boston Scientific Corporation.