Arterial Remodeling Technologies 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.
Arterial Remodeling Technologies (ART) has developed a bioresorbable coronary polymer stents that it says promote the natural remodeling of an injured artery after angioplasty. The stent is designed to provide a transient, yet effective scaffold that dismantles and relinquishes its primary mechanical scaffolding function after three months.
Accordimg to ART’s press release, 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. To that end it’s polymeric stent is designed to perform as effectively as a conventional metallic stent, but will then “relinquishing its scaffolding function” when the stent is no longer necessary to maintain the shape of the vessel.
The exact degradation rate of the material used to build the stent can effectively be “dialled in” by controlling the mix of D and L isomers in the device’s poly-lactic acid polymer make-up. Yet while in vivo data reportedly confirms the theoretical assertion that ART’s stent does indeed start “dismantling” at around three months, only clinical study in a real world setting will confirm this.
So, with the proof of the pudding being in the eating, ARTDIVA is a 30-patient, prospective, first-in-man interventional clinical investigation at five medical centers evaluating the company’s 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).
So 30 day data is only part of the picture, but a reported vessel recoil rate of 4% is consistent with the performance seen using a metallic stent, and a lack of adverse cardiac events provides further encouragement.
Presentation of the ART data at TCT2013 was performed by principal investigator, Jean Fajadet, M.D., Co-Director of the Interventional Cardiology Unit, Clinique Pasteur, Toulouse, France (and a member of ART’s Scientific Advisory Board).
“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.”
“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 bioresborbable stent is not approved for investigational use or sale in the U.S. Neither does it currently carry CE Mark approval for sale in Europe.
Source: Arterial Remodeling Technologies, Business Wire