April 15, 2019
IMPERIAL Subanalyses Support Boston Scientific's Eluvia Stent in Calcified Lesions and CTOs
April 16, 2019—Boston Scientific Corporation announced that results from subanalyses of the IMPERIAL clinical trial for the company's Eluvia drug-eluting vascular stent system were presented by Frank Vermassen, MD, at the Charing Cross Symposium, held April 15–18 in London, United Kingdom.
The global, randomized controlled IMPERIAL trial evaluated the Eluvia stent system in patients with symptomatic peripheral artery disease. Supported by findings from the IMPERIAL trial, the Eluvia device received FDA approval in September 2018 and European CE Mark approval in February 2016.
According to Boston Scientific, the data presented at Charing Cross demonstrate that the safe and efficacious performance of the polymer-coated Eluvia drug-eluting stent does not appear to be affected by challenging lesions, defined as being severely to moderately calcified or completely blocked within the superficial femoral and proximal popliteal arteries.
An analysis assessing outcomes of patients diagnosed with moderately to severely calcified lesions at 12 months found:
- 89.2% primary patency
- 2.8% target lesion revascularization
- 1.1% stent thrombosis
Dr. Vermassen commented in the company's announcement, “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.”
Investigators also analyzed the safety and performance of the Eluvia stent system for patients diagnosed with chronic total occlusions at the target lesion and found that these patients experienced 83.9% primary patency at 12 months, stated Boston Scientific.