The Eluvia stent system was approved based on data from the IMPERIAL non-inferiority trial, which compared Eluvia to Zilver PTX.
The US Food and Drug Administration has approved Boston Scientific’s Premarket Approval application to market Eluvia Drug-Eluting Vascular Stent System, a stent designed to treat peripheral artery disease.
"Over the past decade, we've seen significant advancements in the treatment of peripheral artery disease, yet clinical and economic outcomes still present an opportunity for innovation and to improve patient care," said Jeff Mirviss, senior vice president and president, Peripheral Interventions, Boston Scientific, in a statement. "With the FDA's approval of the Eluvia stent, we can now bring the transformative power of sustained drug release to clinicians and the millions of patients suffering from this terrible disease."
Peripheral artery disease occurs when calcified atherosclerotic material—plaque—accumulates on the walls of arteries in the legs. This restricts blood flow, causes pain and swelling, and can lead to ulcers and even amputation of the affected limb.
The Eluvia stent system is designed to release paclitaxel over a one-year timeframe, preventing tissue regrowth that would block the stented artery.
The FDA’s approval of Eluvia was based on results from the IMPERIAL trial, a randomized, single-blind trial that compared the Eluvia stent to Zilver PTX.
At 12 months, patients treated with the Eluvia stent achieved a significantly greater primary patency (86.8%) compared to those treated with Zilver PTX (81.5%) (difference 5.3%; P <.0001). Patients treated with Eluvia required half the target lesion revascularization rate (4.5%) of those treated with Zilver PTX (9.0%) at 12 months.
"In the IMPERIAL trial, the Eluvia stent demonstrated landmark vessel patency and freedom from target lesion revascularization rates, preventing more than 95% of patients from needing a reintervention after one year," said William Gray, MD, system chief, Division of Cardiovascular Diseases and president, Lankenau Heart Institute at Main Line Health in Wynnewood, Pennsylvania, and co-principal investigator of the IMPERIAL trial.
Additionally, 94.9% of patients in the Eluvia group and 91.0% of those in the Silver PTX group had not experienced a major adverse event at 12 months (difference 3.9%; P <.0001). One patient in the Eluvia arm had a major amputation, and 13 patients in each group required target lesion revascularization. No deaths were reported in either treatment group.
“The Eluvia stent was non-inferior to the Zilver PTX stent in terms of primary patency and major adverse events at 12 months after treatment of patients for femoropopliteal peripheral artery disease,” concluded the investigators of the IMPERIAL trial.
The Eluvia stent system was previously approved for parts of Europe, having received the CE Mark in 2016.
"The Eluvia stent is a breakthrough therapy that marks a significant step forward in the treatment of peripheral artery disease, and now with its approval and commercial availability, it has the potential to make an immediate impact on the quality and value of care that physicians can provide to their patients," added Gray.
Results from the IMPERIAL trial were published in a paper in The Lancet, “A polymer-coated, paclitaxel-eluting stent (Eluvia) versus a polymer-free, paclitaxel-coated stent (Zilver PTX) for endovascular femoropopliteal intervention (IMPERIAL): a randomised, non-inferiority trial.”