NEWS

Boston Scientific Receives U.S. FDA Approval for the Eluvia Drug-Eluting Vascular Stent System

September 26, 2018

First peripheral vascular interventional technology approved in the U.S. to offer sustained release of antiproliferative drug to treat patients with peripheral artery disease

MARLBOROUGH, Mass., Sept. 26, 2018  -- Boston Scientific announced that the U.S. Food and Drug Administration (FDA) has approved its Premarket Approval (PMA) application to market the Eluvia Drug-Eluting Vascular Stent System, specifically developed for the treatment of peripheral artery disease (PAD). The Eluvia stent utilizes a drug-polymer combination to offer sustained release of the drug paclitaxel for a one-year timeframe, designed to prevent tissue regrowth that might otherwise block the stented artery.

Approximately 8.5 million people in the United States are affected by PAD, which occurs when fatty or calcified atherosclerotic material, called plaque, builds up on the walls of the arteries of the legs, restricting blood flow and causing pain, swelling and a diminished quality of life.1 If blood flow is not restored and maintained, severe cases of PAD can lead to pain, ulcers and even amputation of the affected limb.

"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. "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."

The FDA's approval is based on findings from the IMPERIAL trial, in which the Eluvia stent demonstrated superior results in the first superficial femoral artery head-to-head drug-eluting stent trial. 2 In this trial, patients treated with the Eluvia stent experienced a significantly greater 12-month primary patency of 88.5 percent, compared to 79.5 percent in patients treated with Zilver PTX (P=.0119).3 In addition, patients treated with the Eluvia stent experienced half the target lesion revascularization rate of Zilver PTX at 12 months, a 4.5 percent TLR rate for Eluvia versus 9.0 percent TLR rate for the Zilver PTX cohort.

"In the IMPERIAL trial, the Eluvia stent demonstrated landmark vessel patency and freedom from target lesion revascularization rates, preventing more than 95 percent of patients from needing a reintervention after one year," said William Gray, M.D., 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. "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."

The Eluvia stent system is built on the Innova Stent System platform, a self-expanding nitinol stent that has been designed for use in the superficial femoral and proximal popliteal arteries, the main arteries that supply blood to the legs. The Eluvia stent system received CE Mark in 2016.

  1. Centers for Disease Control: https://www.cdc.gov/dhdsp/data_statistics/fact_sheets/fs_pad.htm Accessed September 14, 2018
  2. Superiority determined in Post Hoc Superiority Analysis. 12-Month Primary Patency rate of 86.8 percent in the Eluvia arm vs. 77.5 percent in the Zilver PTX arm (p-value = 0.0144).
  3. Kaplan Meier Estimate