Arterial Remodeling Technologies (ART) has earned ISO 13485 certification for its bioresorbable stent platform which restores remodeling capacity of arterial walls.
Reportedly, the certification to ISO 13485 reinforces through an independent third-party that ART operates its medical device QMS in accordance with the recognised standard.
The data published in a special supplement of EuroIntervention, a peer-reviewed journal in-vivo and in-vitro related to bioresorbable stent platform validates the company’s approach to balance biocompatibility, biomechanics and bioresorption in a bioresorbable PLA (polylactic acid) stent without altering healing by drug elution from the stent platform.
Machiel van der Leest, CEO, said: “ART must be committed to the highest quality in manufacturing its bioresorbable stents. Certainly, achievement of ISO 13485 certification bears strong witness to our promise. There is no doubt our approach to bioresorbable stenting has been validated. The data published by EuroIntervention show that ART’s bioresorbable stent provides the requisite initial mechanical scaffolding to resist recoil.
“Then, as it dismantles over time in a controlled fashion because of its polylactic acid makeup, remodeling returns to the artery. Also critical is that our bioresorbable stent causes little, if any, inflammation in the artery, which further suggests that we may have the option of using, or not using, antiproliferative drugs with our stent. Plus, the endothelialisation we’ve seen at one month post-implant is outstanding.”