ART publishes impressive data on its bioresorbable stent

Jan 5 2010

Arterial Remodeling Technologies (“ART”) announced today that it has disclosed impressive in vivo and in vitro data related to its bioresorbable stent platform—data that validates the Company’s approach to simultaneously balance biocompatibility, biomechanics and bioresorption in a bioresorbable PLA (polylactic acid) stent without altering healing by drug elution from the stent platform.

“These results dramatically confirm our approach to bioresorbable stenting”

These data have been published in the current special supplement of EuroIntervention, a peer-reviewed journal. The paper is authored by Antoine Lafont, M.D., Ph.D., Head, Interventional Cardiology Department, Georges Pompidou Hospital (Paris); Past Chairman, Interventional Cardiology Group, European Society of Cardiology (ESC).

“The ART bioresorbable stent showed a remarkable ability to be deployed without recoil or breakage. At one month, endothelialization was one hundred percent completed. Additionally important, inflammation, smooth muscle cell proliferation and collagen accumulation were equivalent to what typically occurs after balloon angioplasty,” said Dr. Lafont, a co-founder of ART. “At six months, the ART stent was completely integrated into the artery wall, thus preventing any strut migration secondary to the bioresorption process. Further, peak PLA resorption did not result in an increase or even persistence of inflammation as it has been previously reported with other bioresorbable polymer stents. Finally, inflammation and smooth muscle cell proliferation were almost not detectable at six months, resulting in no hyperplasia—in other words, no in-stent restenosis.”

“These results dramatically confirm our approach to bioresorbable stenting,” said Machiel van der Leest, CEO. “The industry has been focusing on mechanical strength of the scaffold. Of course, this is important for the first three months in order to give an artery proper support. But after this period the stent will no longer have a support function, yet it will still remain in the artery for up to 18 months but should not create any issues,” said van der Leest, who previously was a co-founder and Chief Technology Officer of Minvasys. During his career he has developed and successfully introduced 15 Class III medical devices, which require premarket approval and a scientific review to ensure safety and effectiveness.

“The data published in 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 there is no need to use antiproliferative drugs with our stent. Plus, the endothelialization we’ve seen at one month post-implant is outstanding,” added Van Der Leest.