Founded in 2009, Leeds-based Arterius is developing a next-generation bioresorbable cardiovascular scaffold (stent) with an emerging market-leading clinical profile. The founding directors have significant experience in the development of medical devices and in the cardiovascular devices field in particular. The development team is supported by a consortium of experts comprising, amongst others, clinical advisory team; computational design group at Southampton University; polymer process engineering at Bradford University and pre-clinical and clinical institutions. Arterius has recently completed the pre-clinical trials and, on the back of these, believes that this collaboration has delivered a next generation drug eluting fully biodegradable stent with a market leading profile.
MISSION
Arterius was established by Dr Kadem Al-Lamee and Alistair Taylor to exploit opportunities in the $8.1bn coronary stent market. The company has worked in partnership with a consortium of academic contributors consisting of the Computational Design Group at Southampton University, UK; the Industrial Research Centre in Polymer Engineering, Bradford University, UK; and the Department of Surface Characterisation and Drug Distribution at Nottingham University, UK to design, manufacture and put into pre-clinical evaluation a family of novel vascular scaffold stents, under the trademarked name ArterioSorb™.
Product Evolution
Stent technology (including the design, alloy used and strut thickness) developed rapidly in the 1990s. The second generation products appeared in 2000 in response to the continued concerns over restenosis and thrombosis. These stents comprised a BMS which had been coated in anti-proliferative drugs such as paclitaxel (to prevent tissue growth) or anti-inflammatory/immunosuppressive drugs such as sirolimus, everolimus, tacrolimus or dexamethasone (to reduce the inflammation at the site of the stent). These drugs ‘eluted’ over time providing therapeutic concentrations in local tissues but low systemic doses, thus avoiding systemic adverse effects.
Bioresorbable scaffolds (stents) are made from common biopolymers used in medical devices, such as poly(lactic acid (PLA or PLLA), rather than metal. These stents provide mechanical support for a period of time while the artery recovers from the PCI, before dissolving away to leave nothing behind.
The ideal BRS needs to be formed from a polymer that ensures short to mid-term scaffolding of the vessel in order to maintain patency while the vessel heals and remodels. It is still unclear exactly how long a BRS needs to provide a scaffold before full resorption but currently devices resorb after between 6 and 24 months.
There is potential to not only match, but to better the clinical profile of the existing products: Uniquely BRSs, offer the possibility of late lumen gain and enhanced vasomotion. These effects have been observed in early clinical studies. Lower incidence of angina at 1 year after PCI with BRS have also been reported when compared to DES (16% vs 28%, p=0.001). This is likely to be due to expansion of the internal elastic membrane and growth of the lumen as the device begins to dissolve and the vessel is constrained.(Serruys PW, Chevalier B, Dudek D, Cequier A, Carrie D, Iniguez A, et al. A bioresorbable everolimus-eluting scaffold versus a metallic everolimus-eluting stent for ischaemic heart disease caused by de-novo native coronary artery lesions (ABSORB II): an interim 1-year analysis of clinical and procedural secondary outcomes from a randomised controlled trial. Lancet. 2015;385(9962):43-54.)