Clinica's MedTech Ventures: Cardiatis
This article was originally published in Clinica
Specialty area: Endovascular aneurysm repair
Based in: Isnes, Belgium
Founded in: 2002
No. of employees: 39
Total investment received to date: €15m
Investors: Private investors
Currently, aneurysms are treated using either open surgery or covered endovascular stents such as Medtronic’s Endurant and Gore’s Excluder, which are both designed for abdominal aortic aneurysm (AAA). However, these two treatment options have disadvantages. Open surgery is not suitable for certain patients, for example those who are old and frail, as it carries a high risk of mortality and complications such as paraplegia.
As for covered stent grafts, many of these cannot be used in patients with aneurysms in specific locations, such as thoraco-abdominal branched blood vessels. This is because covered stent grafts, as well as shutting off blood flow to the aneurysm, also cover the vital side branches that supply blood to the body, potentially leading to complications such as paraplegia, renal failure and bowel loss.
Cook Medical markets a device called Zenith Fenestrated that has “windows” to accommodate branching vessels – but this is custom-made to each patient, which is time consuming and expensive, and also requires a high level of expertise to implant.
Belgian start-up Cardiatis has developed a device, called the Multilayer Flow Modulator (MFM) stent, which it believes could provide a simpler solution for aneurysms in hard-to-treat locations. The stent isn’t covered but is instead made of a multi-layered mesh, which means that vessel branches remain patent, or open, without having to adapt the structure of the graft to each patient.
The MFM stent is already CE marked in Europe. The firm is hoping for US FDA approval later this year, and the device has fast-track status from the agency.
Cardiatis’s stent works differently to conventional covered stents. While the latter merely create a mechanical barrier between blood flowing through the vessel and the aneurysm, Cardiatis’s stent “slows and laminates blood flow,” reducing the turbulence that caused the aneurysm in the first place.
“There is a misunderstanding among many surgeons,” Noureddine Frid, Cardiatis’s CEO, told Clinica. “They believe what makes aneurysms rupture is pressure. But now we know it’s mainly local turbulence that causes tension on the blood vessel wall, because the rupture does not occur at level of maximum diameter of the aneurysm.” Turbulent flow continuously hits the vessel wall, which damages and weakens the wall, making it bulge out into an aneurysm and leaving it at risk of potential rupture.
Laminar flow, when fluid flows uniformly in parallel layers, is the ultimate aim of Cardiatis’s stent. Dr Frid compared turbulent blood flow to an ill-disciplined, retreating army, and laminar flow to a well-drilled force marching in lines.
The multiple mesh layers of Cardiatis’s stent slow blood flow and lead to a drop in pressure and turbulence, the CEO explained. “The laminar flow removes the stress on the vessel wall, and then the healing process can start.”
The design of Cardiatis’s product means it can be used to treat aneurysms anywhere in the body, regardless of anatomy, the company says. “The technology is a platform, so you can make any size, any length you want,” said Dr Frid.
One surgeon using the stent, Sherif Sultan of University College Hospital Galway in Ireland, described the device as “disruptive technology that will change the face of endovascular surgery for decades to come.” He told Clinica: “It allows the management of wide array of life threatening conditions: as well as complex thoraco-abdominal aneurysms, this also includes cerebral aneurysms and aortic dissections.”
The simple structure of Cardiatis’s stent makes it easy and quick to implant, compared with existing methods. The company says the procedure can be carried out minimally-invasively in 30 minutes with “minimal training.” In addition, most patients are fit to go home the day after the procedure, according to Mr Sultan. Meanwhile, traditional covered stents can take hours to implant, need a highly-experienced surgeon, and patient recovery can take weeks.
The potential market for the MFM stent is large. AAAs occur in 4-7% of adults aged over 65-75 years, while the incidence of thoracic aortic aneurysms is 6-10 per 100,000 person years, according to Mr Sultan. “If these aneurysms are left untreated they will rupture and the chance of death ensuing from rupture is 90%.”
The MFM stent could also provide hope for patients who until now have had no other options, the surgeon continued: “Up until recently if the aneurysm was extensive, or had visceral braches arising from it, or the patient was unfit then the chances of survival from aneurysm repair were slim. The chances of survival without becoming dialysis dependent due to renal failure or suffering from stroke and paralysis or paraplegia were even slimmer.”
Results from a controlled trial, STRATO, have recently been published, showing “favourable clinical outcomes” with the MFM stent. Furthermore, the trial found no cases of paraplegia and only one case of stroke with Cardiatis’s graft one year after implantation. These positive results were achieved “despite the fact that the patients enrolled in the trial were being treated on compassionate grounds due to their existence co-morbid disease and lack of alternative treatment options,” noted Mr Sultan.
Cardiatis has got this far with €15m ($20.6m) in funding, all from private investors. It is planning another €5-10m round this year. One thing the money will go towards is developing the stent in cerebral aneurysm, where the company is developing an antiplatelet coating to prevent blood clotting (which can lead to a stroke).
CEO Dr Frid doesn’t believe there are any other companies developing a similar mesh stent for aneurysm – although there are single-layer stents for cerebral use, he added.
If Cardiatis continues to show benefits with its technology, maybe some of the big players with covered stents, such as Medtronic, Gore, Cook, and smaller UK player Lombard Medical, could soon be interested.
Noureddine Frid, CEO.
Tel: +32 477 760047
Parc Scientifique Crealys, Rue Jules Poskin 3, 5032 Isnes, Belgium.