Boston Scientific (NYSE:BSX) touted one-year data today from an analysis of its Eluvia drug-eluting vascular stent system, showing that the device is safe and effective in patients with long, complex, calcified lesions.
The data were presented by Boston Scientific at the annual Vascular Interventional Advances meeting.
The company’s Imperial trial included a 50-patient, single-arm analysis of Eluvia in people with femoropopliteal artery lesions 140-190 mm in length. These patients had an average lesion length of 162.8 mm, with 70% of lesions characterized as moderately to severely calcified and 32% with chronic total occlusions.
Following treatment with Boston Scientific’s Eluvia device, study participants had a primary patency rate of 87.9% and a target lesion revascularization rate of 6.5%. This sub-group of participants also reported experiencing improvements in their leg pain and discomfort, according to Boston Scientific.
“The lesion lengths, disease complexity and the baseline characteristics presented in this sub-study is more representative of what clinicians see on a daily basis when treating patients with severe cases of peripheral artery disease,” co-principal investigator Dr. William Gray said in prepared remarks.
“The results from this long lesion sub-study, combined with those observed in the global randomized controlled Imperial trial, Majestic and other studies suggest that the Eluvia stent, with its sustained drug release design, is a highly effective treatment option for femoropopliteal disease even in more complex lesion types,” Gray added.
“We are very pleased with the consistent clinical performance of the Eluvia drug-eluting stent across a broad spectrum of patient and lesion subtypes,” Dr. Ian Meredith, EVP & global CMO for Boston Scientific, said. “Without effective treatment options, patients with peripheral artery disease face the risk of developing permanent disability, potential amputation or even death which is why it is critical to ensure clinicians have access to therapies specifically developed to treat individuals suffering from this debilitating disease.”
Boston Scientific’s Eluvia stent is FDA-approved to treat long lesions within the superficial femoral and proximal popliteal arteries in patients with peripheral artery disease.