Evaluation of Aortyx AX-GEN01 enDovascular bioresorbable patcH for treatmEnt of acute and subacute Type B aoRtic dissEction

Aortic dissections (AD) represent a major challenge in the cardiovascular field. Despite being relatively frequent, they have historically received less attention by medical device companies than other cardiovascular diseases. AD is a dramatic condition in which the inner layer of the aorta tears, causing blood to flow through it. The dissection is often fatal if the blood-filled channel ruptures through the outer aortic wall. Current treatments, originally developed for other diseases, fail when imported to use in AD.
Physicians discuss cases, strategies, approaches that can only be taken as individual solutions for each patient. In 2019, Dr Frank Criado, one of the worldwide pioneers in endovascular surgery stated: “10 years ago, we expected that the future would bring innovative devices to treat aortic dissection. The future is now, and we have not seen any significant evolution in the devices we had 10 years ago.”
Current treatments present severe limitations and must be replaced. In open repair, a tubular synthetic graft replaces the damaged vessel. Most used in the ascending aorta, the surgery is extremely invasive, requiring cardiopulmonary bypass and induced hypothermia to prevent brain damage. It is however still the preferred option, despite mortality rates that exceed 30% at times. Endovascular repair reduces this invasiveness by delivering the graft with a catheter, and this reduces mortality drastically. Unfortunately, the complex geometry of the aorta limits its application to less than 25% of AD.
Sadly, the grafted stent fails over time (up to 50% in 5 years) and must be replaced, sometimes urgently, due to a mechanical mismatch between the graft and the aorta. ADs are associated with high recurrent expenses due to the periodical follow-ups during a patients’ lifetime and the intervention costs when required. Other expenses may arise from secondary effects like paraplegia, stroke, or renal failure, leading to reinterventions, where costs per patient multiply. These inefficiencies affect private insurances, decreasing their margins, and Public Health systems, that stress due to the increasing and ageing of the population.
We have invented and patented a biomimetic bioresorbable adhesive patch that is inserted in the aorta using an endovascular catheter and a deployer. The patch adheres to the aortic tear, stops false lumen blood flow, and promotes natural repair and biointegration thanks to its unique microstructure and viscoelasticity. The nitinol deployer is specifically designed to deploy our patch and the catheter carries the whole system throughout the aorta.
Having demonstrated the safety and efficacy of our device in animals, this grant will allow us to move forward through First in human Trials to secure the arrival of the invention to the patients suffering from this fatal disease. Our approach is to provide a solution that has minimal side effects and that improves the life-span and life-quality of patients. Besides, our
patch will increase the intervention success rates of surgeons. Furthermore, public health systems will be able to optimize their budget allocations and private health companies will increase their margins.