FDA Approves Boston Scientific's Promus Element Plus PtCr DES

November 22, 2011—Boston Scientific Corporation (Natick, MA) announced that the US Food and Drug Administration (FDA) has approved the Promus Element Plus everolimus-eluting platinum chromium (PtCr) coronary stent system. The company will begin marketing the device in the United States immediately.

The Promus Element Plus stent system is currently offered in a matrix of 74 sizes, with diameters ranging from 2.25 to 4 mm and lengths ranging from 8 to 32 mm on both monorail and over-the-wire catheter platforms. The company expects that additional stent lengths will be available in mid-2012.

With this approval, Boston Scientific will be shifting from marketing its previous-generation Promus stent in the United States to the internally manufactured Promus Element Plus stent system. The Promus stent is a private-label version of Xience V, designed and manufactured by Abbott Vascular (Santa Clara, CA) and supplied to Boston Scientific Corporation as part of a distribution agreement between the two companies related to the acquisition of Guidant Corporation in 2006.

According to the company, 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 stent system received CE Mark approval in October 2009 and is expected to receive regulatory approval in Japan by mid-2012.

Designed specifically for coronary stenting, the Promus Element's PtCr alloy enables thinner struts and enhanced visibility. The device's design provides a more conformable stent with less recoil and higher radial strength.

Boston Scientific stated that the Promus Element Plus system employs a low-profile delivery system with a dual-layer balloon and the company's Bi-Segment inner lumen catheter. The company noted that 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.

Boston Scientific advised that the Promus Element stent is supported by the comprehensive PLATINUM clinical program, which included five multicenter studies composed of more than 1,800 patients worldwide. In September 2010, data were presented on 30-day and 9-month clinical outcomes and 9-month angiographic and intravascular ultrasound outcomes supporting the safety and effectiveness of the Promus Element stent while showing 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 noninferiority of the Promus Element 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 (bailout 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,” commented Gregg W. Stone, MD, Principal Investigator of the PLATINUM Workhorse trial.

Additional 12-month results from two single-arm subtrials support Promus Element stent's 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 in treating small-vessel coronary disease. The PLATINUM Long Lesion trial showed low rates of revascularization while reporting no cardiac death, myocardial infarction, or stent thrombosis at 1 year in patients with long coronary lesions, stated Boston Scientific.