FDA Clears Promus Element Plus Coronary Stent System

Approval marks transition to internally manufactured everolimus-eluting stent in the U.S.


December 12, 2011

The Promus Element Plus everolimus-eluting platinum chromium coronary stent system is Boston Scientific's next-generation drug-eluting stent (DES) technology.  It is designed to provide physicians improved DES performance in treating patients with coronary artery disease, is built on a platinum chromium (PtCr) platform with the DES market-leading everolimus drug. 

The Promus Element Plus combines the Promus Element stent with an enhanced catheter delivery system engineered for improved deliverability in challenging coronary lesions. 

The Promus Element uses a proprietary PtCr alloy designed specifically for coronary stenting, which enables thinner struts and enhanced visibility.  The innovative  design offers a more conformable stent with less recoil and higher radial strength.  It employs an advanced, low-profile delivery system featuring a dual-layer balloon and Bi-Segment inner lumen catheter designed to facilitate precise stent delivery across challenging lesions.  The everolimus drug and fluorinated copolymer stent coating have been studied in multiple randomized clinical trials and 'real-world' registries, demonstrating excellent long-term safety and efficacy.

The Promus Element Stent is supported by the comprehensive PLATINUM clinical program, which included five multi-center studies totaling more than 1,800 patients worldwide.  In September 2010, data were presented on 30-day and nine-month clinical outcomes and nine-month angiographic and IVUS outcomes supporting the safety and effectiveness of the Promus Element Stent while demonstrating an acute procedural benefit with low rates of incomplete stent apposition.  In April 2011, 12-month results announced from the randomized, controlled PLATINUM Workhorse trial demonstrated the clinical non-inferiority of the Promus Element Stent in comparison to the Promus Stent in treating de novo coronary artery lesions while also showing a procedural benefit of reduced rates of geographic miss and unplanned (bail-out or emergency) stenting.

Additional 12-month results from two single-arm subtrials support Promus Element stent safety and effectiveness in small vessels and long lesions.  The PLATINUM Small Vessel study demonstrated excellent safety and effectiveness outcomes, including no stent thrombosis or myocardial infarction for the 2.25 mm Promus Element stent in treating small vessel coronary disease.  The PLATINUM Long Lesion trial demonstrated low rates of revascularization while reporting no cardiac death, myocardial infarction or stent thrombosis at one year in patients with long coronary lesions.

The Promus Element Plus is currently offered in a matrix of 74 sizes, ranging in diameter from 2.25 to 4 mm and lengths of 8 to 32 mm on both monorail and over-the-wire catheter platforms.  The company expects that additional 32 and 38 mm stent lengths will be available in mid-2012.  Boston Scientific has the industry's most comprehensive coronary stent portfolio, offering physicians and their patients a broad size matrix and the only two-drug platform. 

The company received CE mark approvals for the Promus Element everolimus-eluting stent system in October 2009, and U.S. Food and Drug Administration (FDA) approval in November 2011.

For more information: www.bostonscientific.com