Pilot Study for Acute Device Performance Evaluation of a PLLA Bioresorbable Scaffold in a Swine Model
Arterius Ltd, the bioabsorbable coronary scaffold company have announced positive findings from the acute device performance pilot study for the Arteriosorb™ Absorbable Drug-Eluting Scaffold (ADES).
Micro CT image of implanted Arteriosorb™ ADES
A study performed in conjunction with a very well known lab to evaluate the scaffold for acute performance: introduction and deliverability, visibility by angiography, deployment and expansion performance, and device sizing.
A total of 6 scaffolds were implanted, and the function and performance were rated as generally excellent, with all devices being easy to position and deploy, with no complications encountered during delivery, deployment or withdrawal. Scaffolds were visible by angiographic evaluation due to the radiopaque markers, and showed no abnormality following implantation, with complete perfusion of the blood flow. Optical coherence tomography (OCT) showed good apposition of the struts to the vessel wall.
Micro CT (above) and OCT images (at top) of implanted Arteriosorb™ ADES
In conclusion, the Arteriosorb™ ADES Bioresorbable PLLA Scaffold showed excellent overall implantation behaviour in an acute hybrid farm pig coronary artery model.
Arterius Ltd are now undertaking 30 and 90 day safety and efficacy preclinical studies, which are expected to be completed in Q1 2015.
For further information, please contact: Dr Kadem Al-Lamee, CEO
Telephone: +44 (0) 1274 23687
R&D SMART Award from the Innovate UK to Arterius
Following the successful completion of two projects (supported by a Smart award from the Innovate UK), Arterius has very recently been awarded further funding from the Smart programme to conduct the design, development and validation of a pre-production prototype rig for clinical evaluation of biodegradable stents.
Increasing evidence is demonstrating that next generation biodegradable coronary stents are outperforming traditional permanently implanted drug eluting stents. Only two biodegradable stents are approved for sale within the EU, with several more in development.
Manufacturing of polymer stents introduces significant challenges. Biodegradable polymeric stents do not have the necessary material properties to facilitate crimping onto a balloon catheter, expansion, and to provide radial support to the target vessel. Different approaches have been developed to improve the material properties, including blow moulding, annealing and micro braiding.
Arterius and University of Bradford have developed the proprietary technique of Die-Drawing to improve the mechanical properties. Excellent results have been obtained with financial support from Innovate UK-SMART Awards for proof of concept research and development, including preclinical assessment.
To date, a small-scale R&D die drawing system has been used. Whilst this proved sufficient for preclinical trials, there is now the need for a dedicated novel pre-production prototype die drawing system capable of producing high quality product in a reproducible manner for the manufacture of clinically approved coronary, peripheral, urology and biliary stents.
Dr Kadem Al-Lamee, CEO, said “Development funding supported by the Innovate UK through the Smart programme will significantly help the company to stay ahead of the competition and to continue their ongoing collaboration with three universities in the UK (Universities of Bradford, Southampton and Nottingham) in order to complete this ground-breaking research and to commence clinical trials by 2017”.
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Arterius has developed a polymer-based bioresorbable scaffold (or “BRS”) ArterioSorb™ that is intended to match the ease of delivery of Bare Metal Stent (BMS) and Drug Eluting Stent (DES); come in a range of sizes and lengths; Provide equivalent mechanical performance (radial strength) to the best-in-class DES products.