| Abstract |
Not availableAortic dissection (AD) is the most catastrophic event that can occur in the aorta. AD, with an estimated worldwide incidence of 1/10,000 patients per year, is a result of the tearing of the inner layer of the aortic wall. The blood flow emerging through the tear causes the dissection of the inner (intima) and middle (media) layers of the aorta, through a thin layer called intimal flap (IF). AD is a very severe pathology that becomes fatal, up to 50% of the times, when the blood-filled channel silently ruptures through the outer (adventitia) aortic wall. Despite its severity, current treatments present unacceptably high mortality (up to 30%) and failure (up to 60%) rates, due to their invasiveness and/or to the lack of mechanical adaptation of the used devices to the aortic wall.
To solve this clear unmet medical need, Aortyx, a start-up emerging from the IQS School of Engineering and Hospital Clínic de Barcelona, is developing an innovative solution: an adhesive porous patch that is delivered using a minimally invasive catheter. We call it the endovascular repair patch. It mimics the artery’s mechanical properties and allows cellular regeneration. The implantable part, the patch, and its adhesive are at design freeze stage and the tests in animals have been very successful. Now, Aortyx must demonstrate the same reliability for its delivery system, which started its development later in time.
Aortyx faces a significant challenge. Aortic dissections happen in very enlarged aortae and mimicking them in an animal model is extremely complex. In fact, no laboratory animal presents the same aortic diameters as dissection patients. Consequently, Aortyx must demonstrate the mechanism of action and the device’s safety without the support of animal tests.
This project aims at overcoming these barriers using computational (in silico) and benchtop (in vivo) models. Doing so will smooth the path to obtaining clinical trials authorization by Spanish (AEMPS) and American (FDA) regulatory bodies.
Aortyx will rely on the reputation of CIMNE, a worldwide leader in computational mechanics, to support its mission by collaborating in the development of the numerical methods and the computational techniques that this project requires. CIMNE will be the public partner that Aortyx needs to convince the regulatory agencies. In this project, both institutions will collaborate to create computational models of aortic dissections from real patients, generate benchtop models to validate these simulations and collect enough evidence to convince regulatory bodies that the device is safe to start clinical experimentation.
This project will generate tremendous social impact for aortic dissection patients and their families, who will see how a safer alternative arises; for vascular surgeons who will increase the success rates of their interventions; for hospitals and public health systems, who will benefit from hefty savings in treatment costs of aortic dissection patients, thus allowing local economies to grow. The worldwide market for aortic dissection, valued at more than 500M€, is dominated by American giants such as Gore, Medtronic or Cryolife. Aortyx’s innovative solution could change these market dynamics with a project completely conceived and developed in Spain, therefore strengthening its scientific reputation and economical position. |
