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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. 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. 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=0.0119). 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.
For Further Information
More on the interventional cardiology market in the U.S. can be found in a series of reports published by iData entitled the U.S. Market Report Suite for Interventional Cardiology Devices. This report covers the following market segments: coronary stent, coronary balloon catheter, balloon-inflation device, interventional coronary catheter, interventional coronary guidewire, coronary embolic protection device, coronary atherectomy device, coronary thrombectomy device, chronic total occlusion system, introducer sheath, coronary vascular closure device, diagnostic coronary catheter and guidewire, intravascular ultrasound (IVUS) and optical coherence tomography (OCT).
The iData series on the market for interventional cardiology covers the U.S., Japan, and 15 countries in Europe including Germany, France, the United Kingdom (U.K.), Italy, Spain, Benelux (Belgium, Netherlands and Luxemburg), Scandinavia (Finland, Denmark, Sweden and Norway), Portugal, Austria and Switzerland. Reports provide a comprehensive analysis including units sold, procedure numbers, market value, forecasts, as well as detailed competitive market shares and analysis of major players’ success strategies in each market and segment. To find out more about interventional cardiology device market data or procedure data, register online or email us at [email protected] for an U.S. Market Report Suite for Interventional Cardiology Devices brochure and synopsis.