Medtronic’s Complete SE stent shows efficacy in trial

Medtronic has demonstrated the benefits of its Complete SE (self-expanding) vascular stent for the treatment of atherosclerosis in the superficial femoral artery (SFA) via a new clinical study.

Data from the Complete SE SFA trial showed that use of the medical device was associated with greater freedom from reinterventions in narrowed leg arteries among almost 200 US and European subjects.

After a year, subjects experienced statistically significant improvements in all measures of clinical and functional effectiveness, with benefits persisting after a year of follow-up.

The data from the trial will help support Medtronic's efforts to seek US Food and Drug Administration for the stent in this new specification.

Tony Semedo, vice-president and general manager of the endovascular therapies business at Medtronic, said: "Our commitment to building the clinical evidence to advance peripheral interventional therapies takes many forms. The Complete SE SFA study is a prime example."

Last week, the company initiated a new study to assess the benefits of using evidence-based treatment guidelines among chronic heart failure patients.