Preclinical Development and Testing of Innovative Bioresorbable Stents to Treat Patients with Severe Peripheral Arterial Disease

Peripheral vascular diseases (PVD) are caused by the formation of atherosclerotic plaques/blockages in arteries, which reduce blood supply to brain, heart, kidneys, liver/gut and limbs causing strokes, heart attacks, kidney failure and limb amputations. This condition is also known as peripheral artery occlusive disease or peripheral artery disease (PAD).

The risks of PAD to patients has been reduced with the recent advent of thin-strut permanently implanted metallic balloon-expandable stents delivered percutaneously oevr a wire through a needle in the diseased/blocked peripheral artery. However, the presence of a permanent endovascular device in the artery is associated with a series of problems that can lead to re-narrowing/re-blockage (restenosis) of the arteries and stent clotting (thrombosis). Significant advances in the technology of biodegradable materials have made it possible to make vascular stents that are fully dissolvable over 18-24 months, also called bioresorbable stents (BRS). BRSs are able to mechanically keep opened/support the blockage of the diseased artery wall as well as elute a drug for a predetermined time period after which they are absorbed into the vascular wall. BRS are appealing to NHS clinicians, with potential to become the percutaneous treatment of choice for millions of PAD patients worldwide. Key developmental needs are: biodegradable materials, device/stent profile, wall thickness, thrombogenicity, degradation rate, biomechanical performance, and advanced in-vivo testing by clinical NHS experts, all key aspects that require an advanced multidisciplinary team of experts to ultimately deliver a new generation of BRSs that are safe, at much lower risk of late mechanical fracture and restenosis/thrombosis with a view to improve patient life expectancy and reduce markedly NHS costs.

To this end, Arterius Limited, as the only UK company developing the next generation biodegradable coronary stents, has paired up with the Translational Biomedical Research Centre at the University of Bristol, as the only UK institutional preclinical research facility developing new drugs and biomedical devices at NHS, Home Office and GLPMA standards, to develop, test, and translate to bed side the new BRSs for vascular clinical applications. Together Arterius and TBRC Bristol create a unique UK based partnership able to take on this challenge to expand Arterius's product portfolio and achieve a global clinical reach beyond the already established coronary disease for patient, societal and economical benefits. In turn, this partnership will help TBRC to enhace its national/international projection as the only institutional advanced preclinical research centre in the UK/EU partnering with Industry.