Boston Scientific has announced the first European patient implant of its Promus Element Plus Stent System at the Columbus and San Raffaele Hospitals in Milan, Italy.
It is the company's next-generation drug-eluting stent (DES) technology used to treat coronary artery disease.
The stent leverages a proprietary PtCr alloy designed specifically for coronary stenting, which enables improved visibility, less recoil, conformability and higher radial strength.
The system incorporates a low-profile delivery system with a dual-layer balloon and bi-segment inner lumen catheter to provide precise stent delivery across challenging lesions and minimise balloon growth during inflation for providing high-pressure stent deployment.
Currently, the Promus Element Plus Stent System is available in a matrix of 74 sizes, ranging in diameter from 2.25mm to 4.00mm and lengths of 8mm to 32mm on both Monorail and Over-the-Wire catheter platforms.
Columbus and San Raffaele Hospitals, cardiac catheterisation laboratory director Antonio Colombo said the PtCr alloy and stent design used in the platform provides advantages in conformability and radiopacity compared to other stent platforms.
''This innovative stent is also supported by strong clinical outcomes from the platinum trial, which demonstrated very low rates of revascularisation and stent thrombosis at one year," Colombo added.
In November 2011, the element plus stent system received the US Food and Drug Administration approval following the Platinum trial that 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 stenting.
Boston Scientific intends to commence marketing the product in select European and other CE Mark countries and plans a full market launch in the second quarter of 2012. The company is a developer, manufacturer and marketer of medical devices that are used in a broad range of interventional medical specialties.
Image: The first patient has been implanted with Boston Scientific's Promus Element drug eluting stent. Photo: Frank C. Müller.