Disappearing technology had a strong presence at this year’s EuroPCR conference in Paris, with rival device makers demonstrating the safety and efficacy of their next-generation stents.
Elixir Medical unveiled 1st-in-man clinical results for its DESolve fully bioabsorbable drug-eluting scaffold system, a stent made from a proprietary polymer and coated in novolimus. The entire stent is designed to be absorbed by the body in 1-2 years.
"Bioresorbable scaffolds that restore the coronary vessel to its normal form and function without leaving a permanent implant in the body have long been considered the ultimate frontier in interventional cardiology," principal investigator Dr. Stefan Verheye said in prepared remarks. "Having used the DESolve bioresorbable scaffold system and observed its impressive performance and follow up results, I am confident that Elixir’s DESolve scaffold system has the potential to reduce long-term adverse clinical events, and eliminate the need for long-term dual anti-platelet therapy."
The DESolve study followed 15 patients over 6 months, finding "excellent" late lumen loss, no re-blockage of the artery, no incidents of stent thrombosis and 1 major adverse cardiac event, according to a press release.
Biotronik and Terumo Corp. (TYO:4543) each touted clinical findings for their semi-disappearing stents, which feature a bioabsorbable coating that leaves behind a bare metal stent.
Biotronik released 1-year clinical results from the Biosolve-I 1st-in-man study of its drug-eluting absorbable metal scaffold (Dreams), finding low rates of target lesion failure, and no instances of death or scaffold thrombosis, according to a press release. Other findings suggested that the targeted vessel had regained its natural physiology 6 months after implantation.
"These positive one-year results confirm that we are working in the right direction," vascular intervention sales & marketing VP Alain Aimonetti said in prepared remarks. "We see huge potential for Dreams since it combines deployment and post-dilatation properties and long-term outcomes comparable to DES with the additional benefits of vascular restoration therapy."
Terumo’s Compare II trial found that the company’s Nobori semi-absorbable stent was as good as leading drug-eluting stents by Abbott (NYSE:ABT) and Boston Scientific (NYSE:BSX), TheHeart.org reported.
A randomized all-comers trial of more than 2,700 patients found that the Nobori stent, which elutes biolimus, was non-inferior to the everolimus-eluting standards in reaching its primary endpoint.
