The National Institute of Health (NIH) has awarded a $2.5 million grant to Texas A&M University investigator Duncan Maitland to support a research project for the treatment of life-threatening brain aneurysms, as announced in a press release from the University. The researcher wants to develop a treatment based on polymer foam, with human trials scheduled to begin in 2018.
The NIH three-year grant entitled “Shape Memory Polymer Embolic Foams for Treating Cerebrovascular Aneurysms” was awarded through the National Institute of Neurological Disorders and Stroke (NINDS) and is meant to support Dr. Maitland’s team, which includes investigators from the College of Veterinary Medicine and Biomedical Sciences at Texas A&M, and the Mayo Clinic Medical School.
The research, which is being conducted through a collaboration between the Biomedical Device Laboratory led by Maitland and the startup company Shape Memory Therapeutics, will study the effectiveness of polyurethane-based shape memory polymer foams (SMPs) to treat aneurysms. The investigators believe it could be a more effective and less dangerous way of treating the disease.
Characterized by the presence of bulges and filled with blood in the walls of blood vessels in permanent risk of rupture, aneurysms can be both debilitating and fatal, particularly when located in the brain. In addition, about 30,000 patients in the U.S. suffer cerebral aneurysm ruptures every year, with almost 75% of them dying or enduring neurological debilitating damages.
The conventional treatment currently available for aneurysms is the implantation of platinum coils in blood vessels to decrease vessel wall pressure and enable healing prior to a rupture. Despite its effectiveness, the coils can also be dangerous for the patient. In an inflammation scenario, the healing process can be delayed or the coils can compact throughout time and provoke the rupture or formation of an adjacent aneurysm.
Dr. Maitland aims to overcome these obstacles through the introduction of an alternative method based on aneurysm filling with a polyurethane-based SMP foam, rather than platinum coils. The foam is expected to be modeled into a primary shape before being transformed into a different shape at high temperatures. According to Dr. Maitland, it is its capacity to change forms that makes it a great material for the treatment.
The SMP foam is given a temporary crimped shape before being placed into the blood vessel with a microcatheter, and positioned within the aneurysm. Then, physicians trigger the foam so that it can expand and fill the aneurysm, a process that happens through natural body temperature. The foam will work as a sponge, allowing blood to fill it and forming a clot, accelerating the healing process.
Maitland explained that there are currently no devices that match the volume and surface area of the SMP-based device, which is necessary for the success of the treatment. Previous studies revealed that SMP foams are able to both increase long-term health within the blood vessel regions affected by the aneurysm and reduce the likelihood of aneurysm reforming. In addition, the SMP-based device has also revealed good biocompatibility, decreasing the probability of inflammation and promoting healing. The foams are approved by the U.S. Food and Drug Administration (FDA), and demonstrated superior results in previous studies when compared with two other FDA-approved sutures commonly used in vascular surgical procedures.