Boston Scientific has received the US Food and Drug Administration (FDA) approval for 32 mm and 38 mm lengths of the Promus Element Plus Everolimus-Eluting Platinum Chromium Coronary Stent system.
The Promus Element Stent is made with a proprietary platinum chromium alloy and everolimus drug and is designed for treating coronary artery disease patients.
The FDA approval is based on clinical data support of a prospective, multicenter, single-arm Platinum Long Lesion Trial.
The Platinum Long Lesion Trial was designed to assess the safety and effectiveness of the Promus Element Plus Stent system for the treatment of de novo coronary lesions >24 mm to less than or equal to 34 mm in length.
Northern Michigan Hospital heart and vascular institute program director Louis Cannon said the extensive evidence base from the Platinum trials documents the excellent 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 disease," Cannon added.
The Promus Element Plus Stent system also received CE mark approval in 2011.