Boston Scientific received FDA clearance and is planning to immediately begin marketing its PROMUS Element Plus Platinum Chromium Coronary Stent system. The everolimus eluting stent is essentially the combination of the PROMUS Element Stent coupled with an improved catheter delivery system.
According to Boston Sci’s CEO Hank Kucheman, the stent “marks an important milestone” because it will allow the company to manufacture its own device rather than license it from a third party.
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 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 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. The Company expects that additional 32 mm and 38 mm stent lengths will be available in mid-2012.
Press release: Boston Scientific Receives FDA Approval for PROMUS Element™ Plus Platinum Chromium Stent System …
Flashbacks: Boston Sci’s 2.25mm PROMUS Stent Now Available in U.S. ; Boston Sci’s PROMUS Element Stent Gets Go Ahead in Europe