Healing flow

Cardiatis manufactures a novel and unique platform of endovascular prosthesis for the treatment of aneurysms: The Multi Layer Flow Modulator (MFM®)

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Science

The family of Multilayer Flow Modulator (MFM®) devices is based on a physiological and hemodynamic approach to treatment of aneurysm disease. The flow-modulating effect of MFM® implantation intends to reduce local shear stress along and weakening of the artery wall, decrease the risk of rupture. 

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In an aneurysm, the recirculating blood flow, driven by the change in shape of the artery itself, becomes pathophysiological. The consequent weakening and enlargement and further change in shape of the wall can lead to rupture.

The MFM is constructed of three-dimensional braided wire mesh which aims at transforming the blood flow into a laminar flow as blood passes through the porous layers of the MFM.

The MFM aims at promoting a physiological remodeling of the flow inside the aneurysm while maintaining branch patency.

Pathophysiological blood flow before MFM implantation Blood flow after MFM implantation

Peak wall shear stress prior to MFM implantation  Peak wall shear stress after MFM implantation 

The lamination of blood flow aims at reducing the shear stress along the artery wall, to prevent further weakening of the artery wall and reduce the risk of rupture. 

The laminar flow aims at the formation of an organized thrombus while the formationof endothelial tissue on the MFM is observed. 

The MFM design aims at enhancing the perfusion of organs, 
to avoid serious ischemic complications and improve quality of life. 

Computational fluid dynamics modeling of blood flow inside the aneurysm before MFM implantation (left) and after MFM implantation (right). 

Products

All the Multilayer Flow Modulator (MFM®) devices aim at the following: 
01
Restoration of laminar blood flow in the aneurysmal sac
02
Preservation of branch artery patency
03
Formation of organized stable thrombus in the aneurysmal sac
04
Endothelialization of the device along the vessel wall
05
Minimally invasive implantation procedure

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Intended use 

The Aortic MFM®  currently bears CE-mark approval for the endovascular treatment of patients with aortic aneurysms involving at least one branch, high surgical risks, and a morphology suitable for endovascular repair. 

Features 

  • Maintaining branch vessel patency and improving perfusion 
  • Endothelialization and integration, as the uncovered device allows endothelial tissue to be generated on the braided structure 
  • The flared ends of the Aortic MFM® aim at ensuring device compliance with the aortic wall and optimal sealing at both proximal and distal landing zones to avoid the risk of type I and III endoleaks 
  • Durability based on the the multilayer braided design of the cobalt alloy wires 
  • Low Profile, push-pull delivery system 
Dr. Edward B. Diethrich talking about MFM® Dimensions

Intended use 

The Peripheral MFM® is no longer on the market due to changes in medical device regulation in Europe. The device was previously CE-marked for endovascular treatment of patients with unruptured peripheral artery aneurysms (iliac, visceral, popliteal and subclavian arteries), with morphology suitable for endovascular repair.  

Features 

  • Maintaining branch vessel patency 
  • Endothelialization and integration, as the uncovered device allows endothelial tissue to be generated on the braided structure 
  • Durability based on the multilayer braided design of the cobalt alloy wires 
Dimensions

Outcomes

Since 2009 (for the peripheral device) and 2011 (for the aortic device), more than 4000 MFM® devices have been implanted in patients with aneurysm. Clinical investigations results provide insights on the effect of the MFM® when used in aneurysm, including regarding preservation of the patency of branch arteries and ischemic complications such as spinal cord ischemia and renal failure.

Publications on the use of the MRM® in aneurysm are listed here: 

Publications

Physicians

Cardiatis is committed to offering added-value services to physicians and to support their experience with the Multilayer Flow Modulator (MFM®) technology. 
01
Device sizing services 
02
Case Report
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Corelab services :
The Cardiatis team is available to support physicians in planning cases with the MFM®.
Cardiatis Corelab services include:

In order to ensure rapid processing of CT scans, we recommend physicians to share images with the following minimum quality specifications: 

Quality specifications

Patients

The Multilayer Flow Modulator (MFM®) technology has been developed with the objective of offering a new approach to treatment of aneurysms. Since 2009, more than 4000 MFM® devices have been implanted to treat aneurysm in patients. 

Please discuss appropriate treatment options with your physician :

An aneurysm is a weak spot in a blood vessel that bulges out like a balloon. This happens when the vessel wall becomes fragile, causing blood to flow in a way that puts extra pressure on the weak area. 

If left untreated, this constant pressure—pushing against the vessel with every heartbeat—can cause the aneurysm to burst, leading to severe internal bleeding, which can be life-threatening. 

Aneurysms can develop in various parts of the body, including the brain, abdomen, and legs. While they affect people differently, they are a serious health issue that impacts many lives each year. 

Since the 1990s, doctors have increasingly used a less invasive procedure called endovascular procedure to treat aneurysms. This approach involves guiding a tiny medical device through a thin tube (catheter) inside the blood vessel to reinforce the weakened area of the vessel.  

Compared to traditional open surgery, endovascular therapy requires only small incisions, which means patients recover faster and spend less time in the hospital. 

Since their introduction, endovascular procedures have grown to represent today most of the aneurysm interventions in Europe and the USA.

MFM® devices are designed with a special three-dimensional braided mesh that aims to control blood flow inside an aneurysm. The concept relies on the fact that instead of allowing blood to swirl turbulently, these devices aim to smooth out the flow, making it more gentle and controlled. 

By reducing the pressure and stress on the weakened artery wall—two major factors that can cause an aneurysm to burst—MFM® devices aim at lowering the risk of dangerous bleeding 

Because the MFM® devices are not covered, they allow to keep flow to the branch arteries, which in turn should reduce the risk of paraplegia and other issues caused by restricted blood flow.. 
Through smoothening of the flow, the MFM® aims at creating an organized thrombus in the aneurysm. 

Branch patency
Reduced pressure and stress on the artery wall
Perfusion

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