PARIS -- (BUSINESS WIRE) -- Arterial Remodeling Technologies (‘ART’) reported from the podium yesterday at ‘TCT 2013’ that the Company has successfully completed the 30-day milestone portion of the “ARTDIVA” (Arterial Remodeling Transient DIsmantling Vascular Angioplasty) clinical trial of its novel bioresorbable stent. ART’s next-generation bioresorbable stent is designed to promote positive arterial remodeling and then bioresorb (i.e., ‘disappear’).
Presentation of the ART data was made from the podium yesterday afternoon at TCT 2013 by principal investigator of the ongoing ‘ARTDIVA’ study, Jean Fajadet, M.D., Co-Director of the Interventional Cardiology Unit, Clinique Pasteur, Toulouse, France; and, a member of ART’s Scientific Advisory Board. Dr. Fajadet presented the ART data in the following scientific session—NEXT GENERATION DES AND BIORESORBABLE SCAFFOLDS, Session V. Fully Bioresorbable Vascular Scaffolds (BRS).
“I am very pleased with the event-free results we have seen at 30 days with the ART stent. In particular, I am impressed by the simplicity of the deliverability of the stent, as well as its excellent apposition to vessel walls as validated by OCT (optical coherence tomography),” said Dr. Fajadet.
“The independent measurement of acute angiographic recoil for the ART stent by quantitative angiography at just 4.0% confirms the metallic‐stent‐like scaffolding performance of ART’s bioresorbable stent,” added Jeffrey J. Popma, M.D., Director, Beth Israel Deaconess Medical Center Angiographic Core Laboratory and Professor of Medicine, Harvard Medical School.
“We are pleased with these positive clinical results at 30-day follow-up, and we now look forward to reporting additional data at the all-important 12-month angiographic follow-up milestone,” 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.
“Investigators at the five ARTDIVA clinical trial sites are enthusiastic about using our next-generation bioresorbable stent for three important reasons: (1) it is made of a biocompatible material and (2) is designed to have a programmed transitory presence in order to (3) facilitate natural remodeling, and is thus unique among bioresorbable stents on the market and in development,” added Machiel van der Leest, CEO of ART.
ART’s bioresorbable stent is designed to provide a transient effective scaffold that dismantles and relinquishes its primary mechanical scaffolding function after three months. 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. “Our stent, or bioresorbable scaffold, is designed to perform as effectively as a conventional metallic stent, but with the significant advantage of relinquishing its scaffolding function when the stent is no longer necessary to maintain the shape of the vessel,” van der Leest said.
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 at 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 (quantitative coronary angiography) and OCT (optical coherence tomography).
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 bioresborbable stent is not approved for investigational use or sale in the U.S.