Phenox GmbH announced that the p64 Flow Modulation Device has received the CE mark approval for commercialisation within the European Union. Hermann Monstadt, managing director at phenox, Bochum, Germany, said: “This approval supports our strategy of moving neurovascular therapies forward through technological innovation and adds to our product portfolio in a way that supports physicians with better tools and as a result provide additional benefits to patients with complex brain aneurysms.”
The phenox p64 Flow Modulation Device is a new class of embolization device that is designed to divert blood flow away from the aneurysm while reconstructing and reinforcing the vessel wall. According to Phenox, the 64 nickel titanium wire mesh provides a dense lattice for new skin to re-line the diseased vessel and thus closing the opening of the aneurysm and providing a complete and durable aneurysm cure while maintaining patency of the parent vessel.
It is also the first flow diverter that can be deployed completely, recovered completely and redeployed. Pedro Lylyk, ENERI Medical Institute, Buenos Aires, Argentina said: “The p64 Flow Modulation Device from phenox represents the forth generation of flow diverters. The fact that it can be deployed completely and recovered completely offers a new level of operator security and patient safety.”
James Lago, consultant vice president for Global Sales and Marketing at phenox said: “The p64 Flow Modulation Device significantly improves the ease of use for physicians.” Phenox will be conducting a post market surveillance study in eight centres in seven countries to capture long term data for up to 24 months post-treatment.