PARIS–(BUSINESS WIRE)–Arterial Remodeling Technologies (“ART”) reported today
that in vivo data strongly suggest that its second-generation bioresorbable
stent promotes positive arterial remodeling in a post-angioplasty porcine model
at three months follow-up. In addition, acute safety data are excellent: there
have been more than 250 MACE-free consecutive implantations of its
bioresorbable stent in its preclinical phase of development.
The Company also reported that it has appointed interventional
cardiologist Jean Fajadet, M.D., to its scientific advisory board. Dr. Fajadet
is Co-Director of Interventional Cardiology at Clinique Pasteur, Toulouse, France;
and, President of the European Association of Percutaneous Cardiovascular
“We are extremely pleased to have Dr. Fajadet, a key
international opinion leader in interventional cardiology, join ARTs
scientific advisory board,” said Machiel van der Leest, CEO. “Dr. Fajadet will
play a critical role as we move toward our First-in-Human milestone with our
second-generation bioresorbable stent.”
ARTs bioresorbable stent is designed to provide a transient
effective scaffold that dismantles and relinquishes its primary mechanical
scaffolding function after three months. According to van der Leest, who has
developed and successfully introduced 15 Class III medical devices during his
career, this three-month scaffolding period is commonly recognized by experts
as the requisite length of time necessary to allow the healing process to
stabilize the artery following the trauma generated by angioplasty, and to
avoid recoil and constrictive remodeling. Extensive in vivo data demonstrate
that ARTs polymer is designed to be safe while triggering only a minimal
inflammatory response that is typical for biocompatible resorption processes.
“The key characteristics of ARTs second-generation
bioresorbable stent are that it is made of non-aggressive material, has a
programmed transitory presence, and-most important-facilitates natural remodeling”
said Antoine LaFont, M.D., Ph.D., Professor of Medicine, Head Interventional
Cardiology Department, Georges Pompidou Hospital (Paris); and, Past Chairman,
Interventional Cardiology Working Group, European Society of Cardiology (ESC).
Pr. LaFont is a co-founder of ART.
ARTs novel biopolymers have been developed in conjunction
with one of the worlds leading authorities in bioresorbable polymers, Research
Professor Michel Vert, Ph.D., who is Former Director of the Research Center
for Artificial Biopolymers at Frances
National Center for Scientific Research (Centre
National de Recherche Scientifique/CNRS). Pr. Vert is a co-founder of ART.
Arterial Remodeling Technologies (“ART”) is developing bioresorbable coronary
polymer stents that promote the natural remodeling of an injured artery after
angioplasty. The Companys technology is based on intellectual property
originating from three esteemed institutions: the Cleveland Clinic; the French
national research institute, CNRS (Centre National de Recherche Scientifique), Montpellier, France;
and, Descartes University,
CAUTION: ARTs bioresborbable stent is not approved for
investigational use or sale in the U.S.