Imperial clinical trial yields positive results for Boston Scientific

Results from the Imperial clinical trial for the polymer-coated Eluvia drug-eluting vascular Stent System have demonstrated that the efficacy and safety performance of the stent does not appear to be affected by lesions that are severely to moderately calcified or completely blocked within the superficial femoral and proximal popliteal arteries.
Part of the trial evaluated the Eluvia Stent System in patients with symptomatic peripheral artery disease, and assessed outcomes of patients diagnosed with moderate to severely calcified lesions. It found a primary patency rate for patients diagnosed with moderate to severe lesion calcification of 89.2%. It also reported just 2.8% of target lesion revascularisation in patients with moderate to severe lesion calcification at 12 months, and just 1.1% of stent thrombosis for patients treated with the Eluvia stent who were diagnosed with moderate to severe lesion calcification.
Executive vice president and global chief medical officer at Boston Scientific, Ian Meredith, said: “The data adds to the clinical evidence supporting the Eluvia Stent System as a viable first-line treatment option for patients suffering from debilitating peripheral artery disease. Designed with a controlled release of the lowest possible drug dose to seek the best clinical outcomes, we believe the Eluvia stent can become a preferred therapy option and look forward to continued clinical successes with this product.”
Frank Vermassen, Ghent University Hospital, Gent, Belgium, an investigator in the Imperial trial, said: “Our analysis demonstrated the Eluvia stent is a highly effective treatment option for some of the most complex lesion classifications commonly associated with femoropopliteal disease. The findings underscore the ability of this stent to successfully treat varying lesion characteristics, and its performance will continue to be observed in ongoing patient follow-up.”