Boston Scientific Receives CE Mark for Eluvia Drug-Eluting Vascular Stent and Announces Initiation of New Clinical Trial

 First polymer-based, drug-eluting stent designed to treat peripheral lesions above the knee approved in Europe; IMPERIAL trial initiated to seek regulatory approvals in U.S. and Asia

Feb 22, 2016 —  Boston Scientific announced that the Eluvia Drug-Eluting Vascular Stent System has received CE Mark and is commencing commercialization immediately in the European Union and other countries where CE Mark is recognized. 

The Eluvia Stent System is designed to restore blood flow in the peripheral arteries above the knee – specifically the superficial femoral artery and proximal popliteal artery. The stent features a unique drug-polymer combination intended to facilitate sustained release of the drug (paclitaxel) that can prevent narrowing (restenosis) of the vessel, often the cause of pain and disability for patients diagnosed with peripheral artery disease.

CE Mark 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 and reflected a primary patency rate of more than 96 percent¹.  The MAJESTIC trial results represented the highest 12-month primary patency reported for an interventional treatment of femoropopliteal artery lesions among comparable trials.

“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,” said Professor Stefan Müller-Hülsbeck, M.D., PhD, principal investigator at the Vascular Center Diako Flensburg and head of the Department of Diagnostic and Interventional Radiology / Neuroradiology, Academic Hospitals Flensburg, Germany. “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.”

Boston Scientific received an Investigational Device Exemption (IDE) to conduct a global, prospective trial called the IMPERIAL trial, which will assess the safety and efficacy of the Eluvia Stent System compared to the Zilver^® PTX^® Stent manufactured by Cook Medical. Enrollment began in Q4 last year and the study will include approximately 485 patients in 75 sites worldwide.

“The availability of the Eluvia Stent System to European patients, paired with the expansion of our existing clinical program, demonstrates the momentum of our drug-eluting portfolio in combatting peripheral artery disease,” said Jeff Mirviss, senior vice president and president, Peripheral Interventions, Boston Scientific. “Our legacy with drug-eluting technology combined with our commitment to further advance treatment options for peripheral artery disease, enables Boston Scientific to continue bringing ground breaking solutions for patients around the world.”

About the Eluvia Stent System
The Eluvia Stent System is the first stent specifically designed for deployment in the superficial femoral artery (SFA) that utilizes the anti-restenotic drug paclitaxel in conjunction with a polymer. This drug and polymer combination is intended to facilitate sustained release of the drug over the period of time when restenosis is most likely to occur, preventing tissue growth that might otherwise block the stented artery. The Eluvia Stent System is built on the Innova™ Stent System platform, consisting of a self-expanding nitinol stent and an advanced, 6F low-profile triaxial delivery system for added support and placement accuracy. The innovative 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.

In the U.S., the Eluvia Stent System is an investigational device and is not available for sale.

1.  Primary patency defined as duplex ultrasound peak systolic velocity ratio < 2.5 and absence of TLR or bypass; data reflect actual values (not Kaplan Meier estimates).