Cardiatis (Isnes, Belgium) creates multilayer flow modulator stent offering non-invasive alternative for the treatment of a “Silent Killer”

Stemming from the idea of the continuous flow of jet induced fountains, Cardiatis CEO, Noureddine Frid, imagined that if the theory of “fluid mechanics” could be applied to converting turbulence to laminar flow in the blood vessel, the aneurysm (a localized dilation of a vessel wall) could be treated. In other words by regulating the speed of blood flow, the negative effect of pressure would be reduced.

Having worked with companies active in the medical treatment of heart disease since the 1990s, Mr. Frid had the medical know-how and innovative mind to consider using “fluid mechanics” as a potential and global solution for aneurysm treatment. As a result and with thanks to the 4- year Walbiostent* project, Mr. Frid was able to design and develop an advanced new generation of multilayer flow modulator stents. Developed in collaboration with a manufacturer from Lyon and a consortium** of research centres and engineers from Belgium, a machine resembling a highly intricate mesh-like structure consisting of thousands of intertwined gears was produced.

Each year 120,000 endovascular aneurysm repair procedures are performed worldwide. As common knowledge, the main purpose of endovascular aneurysm repair is to prevent death from a ruptured aneurysm, whether cerebral, peripheral or aortic, ideally by completely removing the aneurysm from circulation while keeping the branches and collaterals patent so as to avoid stroke and spine cord and visceral ischemia. But, in many cases complete removal is either too difficult to perform due to the location or just not suitable for certain types or sizes of aneurysms.

Cardiatis with its multilayer technology platform is striving to change this situation.

How does it work?

The self-expanding stent, composed of three layers of woven wire (cobalt), effectively regulates the blood flow inside the aneurysm, while its three dimensional structure simultaneously regulates hemodynamic flow within the affected artery, reducing pressure within the aneurysm and slowing blood flow through its vortex. As a result, a thrombus is formed and the aneurysm is able to close physiologically. Dr Diethrich, of the Arizona Heart Institute and one of the most well-known cardiovascular surgeons worldwide explains (watch video). Moreover, the multilayer mesh-like stent involves a non-invasive and more ‘comfortable’ procedure that requires only local anesthesia. As a result there is no trauma and the patient can return home the next day.

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What makes it different from traditional stents?

Until now, single layer stents have been used clinically to resorb aneurysms but, their clinical applications have been limited because for such an effect to happen, the porosity of the stent mesh must be reduced to such low levels that stent rigidity and compromise is often the result. It also differs from conventional stents made of a solid metal tube because it naturally preserves the irrigation of collateral arteries. Test results have shown hemodynamic changes induced by these stents leading to reductions (over 90%) in blood flow velocity within aneurysms to be two times higher than the velocity reduction induced by any commercially available single layer stent.

According to the Walbiostent project, Cardiatis is the only company developing such a device for the treatment of cerebral aneurysm (saccular and bifurcated) without coil; and a non-covered stent that allows healing of all other peripheral aneurysms.

Although Mr. Noureddine Frid understands that while some are hesitant to this paradigm shift, this innovative technology is sparking more and more interest from doctors worldwide and many scholars are quickly recognizing the potential of this multilayer stent. The market has been growing at a double digit rate over the past five years and future growth will be driven mainly by application of this technology to the vast unmet medical treatment needs of the near impossible-to-approach thoracoabdominal aortic aneurysm, aortic dissection, popliteal, visceral and difficult-to-coil wide neck cerebral aneurysm. Since the first applied treatment in 2006, a total of nearly 4,600 implant procedures have been performed in the aorta, cerebral arteries and peripheral arteries (iliac, popliteal, etc.) worldwide. The the market for flow modulation is expected to double digit by 2015.

The Namur based company, located in a newly inaugurated 2-story 8,000 m² building at the Parc Crealys, currently employs 35 people, including several engineers and is demonstrating how to be a leading player in its sector. With a turnover of €4 million in 2012, of which one hundred percent was for export, Cardiatis intends to become a leader in the treatment of aortic, cerebral and peripheral aneurysm stenting with hopes of becoming an equally important player among other competitive leaders such as the United States. As for now, locally, since the procedure is not currently reimbursed in Belgium, the company is performing it for free in the framework of a registered study. Consequently, this year the start-up plans to double its turnover by bringing in €9 million with the intention to hire more distributors and continue to export to other countries. Without a doubt, Cardiatis will continue to demonstrate its efforts of providing open innovation through local collaborations and bring together different teams to maintain a competitive positioning and continue development.

Thanks to “fluid mechanics” this revolutionary product could indeed prove to be the most effective and alternative solution to overcoming what for years has been known as the “silent killer” of so many.

*The Walbiostent project had been focusing its study on the interaction between stent, arterial wall and blood, related to atherosclerosis disease while Cardiatis’ involvement in the project has been focusing on the effect of the multilayer stent relative to shear stress flow that prevents hyperplasia and anti-platelets aggregation.

**Consortium comprises companies: Cardiatis (Coordinator), BIO.be and Research centers: FUNDP (URBC), UCL (ILS), CHU Charleroi ULB (Experimental medicine), Ecole polytechnique (Faculty of Engineering Mons)