Having worked with companies active in the medical treatment of cardiovascular diseases since the 1990s, Frid had the medical know-how — and the innovative mind — to consider fluid mechanics as a potential and global solution for aneurysms, as well as for aortic dissection (a similar disease). Thanks to the four-year, BioWin-supported Walbiostent* project, Frid was able to design and develop an advanced new generation of multilayer flow modulator stents. Manufacturers from Lyon — together with a consortium** of research centers and engineers from Belgium — developed an apparatus resembling a highly intricate mesh-like structure that consists of thousands of intertwined gears.
A self-expanding stent
Composed of three layers of braided wire (Phynox), the Cardiatis MFM® regulates the blood flow inside the aneurysm. Its three-dimensional structure simultaneously regulates hemodynamic flow within the affected artery, reduces local stress within the aneurysm and laminates the blood flow. As a result, a thrombus is formed and the aneurysm is able to close physiologically. “Moreover,” Frid adds, “placement of this stent only requires a short, minimally invasive procedure that can be done under local anesthesia. This means there is no trauma and the patient can return home the next day.”
What makes it different from traditional stents?
Conventional stents (commonly named stent-grafts) are considered the standard form of care in the industry. Made from an impermeable polyester fabric, they isolate aneurysms from blood flow. However, due to their rigid structure, these devices can create massive complications in veins or arteries close to the deployment zone, such as paraplegia, renal malfunction, failure of visceral organs and even death. “The Cardiatis MFM® differs from these, as it naturally preserves the blood circulation in branches and collateral vessels,” Frid explains. “Test results have shown that the hemodynamic changes induced by the Cardiatis MFM® lead to reductions of over 90% in blood flow velocity within aneurysms. This is two times more than what is possible with any commercially available single layer stent.”
“Cardiatis is the only company developing a device for the treatment of all types of aneurysms (saccular, fusiform, branched and bifurcated) in all locations (cerebral, peripheral, aortic, abdominal); it is the only device promoting aneurysm healing through endothelialization while keeping the patency of branches and collateral vessels. This constitutes a paradigm shift in aneurysm treatment,” Frid says.
Simulation has been an indispensable design tool for the product development.
“I understand that some people are hesitant regarding this paradigm shift,” Frid continues. “However, this innovative technology is sparking the interest of doctors worldwide, and many scholars and key opinion leaders in the field are quickly recognizing the potential of the MFM®. At the same time, the limitations of the current stent-graft technology for the treatment of complex cases such as thoracoabdominal aortic aneurysms, aortic dissection, juxta- and pararenal aneurysms or cerebral aneurysms are becoming apparent.”