Healthcare Industry News: bioresorbable stent
News Release - May 15, 2012
Arterial Remodeling Technologies (“ART”) receives regulatory approval to begin First-In-Man “ARTDIVA” clinical trial with its next-generation bioresorbable stentPrincipal investigator is Jean Fajadet, M.D.
“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.” - Renu Virmani, MD, Medical Director/President, CVPath Institute, Gaithersburg, Maryland
PARIS--(Healthcare Sales & Marketing Network)--Arterial Remodeling Technologies (“ART”) reported today that it has received regulatory approval in Europe to begin its First-In-Man “ARTDIVA” (Arterial Remodeling Transient DIsmantling Vascular Angioplasty) clinical trial next month at five medical centers. ART’s in vivo data strongly suggest that its next-generation bioresorbable stent is designed to promote positive arterial remodeling.
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 the Board of Directors, EuroPCR; and, a member of ART’s Scientific Advisory Board.
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 ART’s CEO Machiel 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.
“We are extremely pleased with this significant 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.
“We are very much looking forward to the results of ART’s First-In-Man study. The key features of ART’s next-generation bioresorbable stent are that it is made of non-aggressive material and is designed to have a programmed transitory presence in order to facilitate natural remodeling,” concluded CEO van der Leest.
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.
Source: Arterial Remodeling Technologies
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