A better implant for treating cerebral aneurysms

The intense collaboration between material science researchers and technology companies from Germany’s North Rhine-Westphalia Region led to the creation of the p64 Flow Modulation Device – a highly effective, self-expandable and radiopaque implant device used for treating cerebral aneurysms. 

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The phenox p64 Flow Modulation Device for the treatment of haemorrhagic stroke. © phenox GmbH The phenox p64 Flow Modulation Device for the treatment of haemorrhagic stroke. © phenox GmbH

" Finally, a highly effective, self-expandable and radiopaque implant has been developed – a significant improvement to existing devices is the new and improved handling of the flow diverter. "

Dr. Ing. Hermann Monstadt, Managing Director

Strokes effect over 1 million people worldwide and, behind heart disease and cancer, are the third leading cause of death. In Germany alone, nearly 250 000 people suffer from a stroke every year. Cerebral haemorrhages, caused by the tearing of vascular aneurysms, is one of the causes of strokes. Commonly referred to as a brain aneurysm, these spindle-like extensions of arteries arise as a result of either acquired or congenital changes in a vessel’s wall. Although often deadly, the good news is that – if found early and treated effectively – a brain haemorrhage can be prevented, thus averting the severest mental and physical consequences to the patient.

A new way to treat aneurysms

Unlike a closure of an artery, aneurysm treatment requires a change to the blood vessel’s wall. As this change can occur in various manifestations, it poses a high risk to the patient. To help minimise this risk – and thus save more lives – phenox GmbH received EU-funding to develop a product that meets the complex requirements for treating aneurysms. The result is the p64 Flow Modulation Device. The innovative device has a physical impact on the targeted vessel, slowly interrupting the blood flow into the aneurysm and thus minimising the risk of a rupture. 

Finding the right material

As the new implant device permanently remains in the vessel, a challenge to its successful development was finding a bio-compatible material. Researchers tested microfiber structures with different diameters and lengths, along with different material and alloy types. They finally settled on the use of Nitinol round wires for self-expansion. They also used helical winded platinum wires so the device is visible in x-rays.

The world’s most advanced flow diverter

Approved for use in 2012, the p64 Flow Modulation Device has built a reputation as a self-expanding radiopaque implant. In fact, as the only device that allows for complete deployment and full recovery, and has been listed as the world’s most advanced flow diverter, says the company.

Total investment and EU funding

Total investment for the project “Flow Diverter - Entwicklung eines Implantats zur endovaskulären Aneurysmatherapie” is EUR 1 237 424, with the EU’s European Regional Development Fund contributing EUR 684 948 through the North Rhine-Westphalia Operational Programme for the 2007-2013 programming period. 

 

Draft date

17/11/2017