Stentys SA (EPA:STNT) today touted the results of its Apposition IV trial comparing the company’s Stentys self-apposing sirolimus-eluting coronary stent to Medtronic‘s (NYSE:MDT) Resolute stent in patients with ST-segment elevation myocardial infarction.
Results from the study were published in the journal EuroIntervention this month.
Stentys calls its suite of Apposition stents the “world’s 1st and only self-apposing stent to treat acute myocardial infarction,” with a shape and size that adapts to “fit snugly” into blood vessels to prevent gaps that can lead to blood clots.
Data from the study indicated that Stentys-stent treated patients demonstrated statistically better stent apposition than those in the balloon-expandable Resolute group at 4 months, with a greater percentage of stents fully covered, the company said. The Stentys SES group showed no reduction in artery lumen diameter with near perfect strut coverage at 9 months, Stentys said.
“The Self-Apposing Sirolimus-eluting stent, which is now commercialized with its new delivery catheter under the brand Xposition S, is the only stent that can guarantee complete and continuous apposition even when treating heart attack patients. We believe this publication will reinforce the adoption of our technology among cardiologists looking for the optimal stent solution for their patients,” CEO Gonzague Issenmann said in prepared remarks.
A total of 152 patients were included in the trial, which was randomized 3:2 to the Stentys stent cohort. The trial took place over 19 months at 12 sites in 5 countries.
“The absence of any reduction in minimum lumen diameter combined with a very high rate of strut coverage is a good indicator of long-term safety for the Stentys SES. Another interesting finding is the augmented lumen size in the Stentys arm: with the addition of sirolimus elution, this benefit is extended to four and nine months,” study authors wrote.
The trial was originally launched in June 2012, when Stentys announced the trial pitting its Apposition stents against Medtronic’s Resolute.