FDA approves Promus Element stent system


The US Food and Drug Administration (FDA) approved Boston Scientific’s Promus Element Plus Everolimus-Eluting Platinum Chromium Coronary stent system, the company’s next-generation drug-eluting stent (DES) technology designed to treat patients with coronary artery disease. 

The Promus Element stent 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 Promus Element is supported by the PLATINUM clinical programme, which included five multicentre 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 randomised, 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.


“The clinical results we observed with the Promus Element stent compared to the Promus stent in the large-scale PLATINUM Workhorse trial, including extremely low rates of stent thrombosis, demonstrate that excellent clinical outcomes are achieved with this novel coronary stent system,” said Gregg W Stone, professor of Medicine and the director of Research and Education at the Center for Interventional Vascular Therapy at Columbia University Medical Center/New York-Presbyterian Hospital and principal investigator of the PLATINUM Workhorse trial.


Additional 12-month results from two single-arm subtrials support the 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 revascularisation while reporting no cardiac death, myocardial infarction or stent thrombosis at one year in patients with long coronary lesions.

The Promus Element Plus stent system is currently offered in a matrix of 74 sizes, ranging in diameter from 2.25 mm to 4.00 mm and lengths of 8 mm to 32 mm on both Monorail and Over-the-Wire catheter platforms. Boston Scientific expects that additional 32 mm and 38 mm stent lengths will be available in mid-2012.