Boston Scientific Launches Eluvia DES in Europe and Begins IMPERIAL Global Trial
February 24, 2016—Boston Scientific Corporation announced that its Eluvia paclitaxel-eluting vascular stent system has received CE Mark approval and is commencing commercialization immediately in the European Union and other countries where the CE Mark is recognized.
The company stated that the Eluvia stent system is designed to restore blood flow in the peripheral arteries above the knee—specifically in the superficial femoral artery and proximal popliteal artery. The stent’s drug-polymer combination is intended to facilitate sustained release of paclitaxel to prevent restenosis of the vessel.
The Eluvia device, which is built on the company’s Innova stent system platform, consists of a self-expanding nitinol stent and a 6-F low-profile triaxial delivery system for added support and accurate placement. The stent architecture features a closed-cell design at each end of the stent for more predictable deployment and an open-cell design along the stent body for improved flexibility, strength, and fracture resistance.
According to Boston Scientific, the European approval was based on data from the MAJESTIC trial, a prospective, multicenter clinical trial that assessed the safety and performance of the Eluvia stent system. Results from the MAJESTIC trial, which were presented in September at CIRSE 2015, the Cardiovascular and Interventional Radiological Society of Europe annual scientific meeting in Lisbon, Portugal, demonstrated a primary patency rate of more than 96% and a 12-month target lesion revascularization rate of 3.8%, with no observed stent fractures and no amputations.
In Boston Scientific’s announcement, MAJESTIC Principal Investigator, Prof. Stefan Müller-Hülsbeck, MD, commented, “The exceptional 12-month results presented in the MAJESTIC trial, which included a high percentage of patients with complex lesions, demonstrate that this technology is a safe and efficacious solution for patients needing stents for the treatment of peripheral artery disease. The approval is a testament to the strength of the data and will be welcome news to physicians and patients who have not previously had access to a polymer based, drug-eluting stent, specifically developed for the superficial femoral and proximal popliteal arteries.” Prof. Müller-Hülsbeck is with the Vascular Center Diako Flensburg and is Head of the Department of Diagnostic and Interventional Radiology/Neuroradiology at Academic Hospitals Flensburg in Flensburg, Germany.
Additionally, Boston Scientific advised that it has received an investigational device exemption from the US Food and Drug Administration to conduct the IMPERIAL global prospective trial that will assess the safety and efficacy of the Eluvia stent system compared to the Zilver PTX paclitaxel-eluting stent (Cook Medical). Enrollment began in the fourth quarter of 2015, and the study will include approximately 485 patients in 75 sites worldwide. In the United States, the Eluvia stent system is an investigational device and is not available for sale.