PARIS--(BUSINESS WIRE)--Jul 16, 2012--Arterial Remodeling Technologies (“ART”) reported today that the Company has achieved a medical milestone with its “ARTDIVA” ( A rterial R emodeling T ransient DI smantling V ascular A ngioplasty) clinical trial: the successful First-in-Human implantation of its novel biodegradable stent into an 61-year-old male who was suffering from a blocked coronary artery and needed a percutaneous coronary intervention (PCI). ART’s next-generation bioresorbable stent is designed to promote positive arterial remodeling and then bioresorb (i.e., ‘disappear’) in approximately 18 months.
Principal investigator for the ART First-In-Man study is Jean Fajadet, M.D., Co-Director of the Interventional Cardiology Unit, Clinique Pasteur, Toulouse, France; and, a member of ART’s Scientific Advisory Board. After the case, Dr. Fajadet stated, “I am pleased with the first human use of the ART stent. I was impressed with the deliverability of the stent, and its good apposition as shown by OCT.” “We are very proud of this important milestone in the development of the ART bioresorbable stent,” 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.
“The ARTDIVA clinical trial is being conducted at five sites,” added Machiel van der Leest, CEO of ART. “Investigators are eager to use our next-generation bioresorbable stent because of its key features: it is made of non-aggressive material and is designed to have a programmed transitory presence in order to facilitate natural remodeling, and is thus unique among bioresorbable stents on the market and in development.” ART’s bioresorbable stent is designed to provide a transient effective scaffold that dismantles and relinquishes its primary mechanical scaffolding function after three months. According to CEO van der Leest, who has developed and successfully introduced 15 Class III medical devices during his career, a 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 trauma generated by angioplasty, and to avoid recoil and constrictive remodeling.
As previously reported by ART in a news release on April 4, 2012: “Our analysis of ART’s in vivo data confirms that stent dismantling is occurring at around three months, and the overall safety data look encouraging thus far,” said Renu Virmani, MD, Medical Director/President, CVPath Institute, Gaithersburg, Maryland. Dr. Virmani also is Clinical Professor, Department of Pathology at Georgetown University, University of Maryland-Baltimore, Uniform University of Health Sciences, and Vanderbilt University.
ARTDIVA is a 30 patient, prospective, first-in-man interventional clinical investigation in five medical centers to evaluate the ART bioresorbable stent for the treatment of patients with de novo lesions. The primary endpoint is six months MACE rate; and the key secondary endpoint is the artery lumen evolution over the first 12 months as validated via QCA and OCT.
About Arterial Remodeling Technologies (“ART”) Arterial Remodeling Technologies (“ART”) is developing bioresorbable coronary polymer stents that promote the natural remodeling of an injured artery after angioplasty. The Company’s 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, Paris.
CAUTION: ART’s bioresorbable stent is not approved for investigational use or sale in the U.S.CONTACT: Ronald Trahan Associates Inc.
Ronald Trahan, APR, 508-359-4005, x108 KEYWORD: EUROPE FRANCE INDUSTRY KEYWORD: HEALTH BIOTECHNOLOGY CARDIOLOGY CLINICAL TRIALS MEDICAL DEVICES MEDICAL SUPPLIES SOURCE: Arterial Remodeling Technologies Copyright Business Wire 2012 PUB: 07/16/2012 09:17 AM/DISC: 07/16/2012 09:17 AM http://www.businesswire.com/news/home/20120716005772/