phenox receives CE Mark approval for p64 brain embolisation device
6 November 2012
phenox GmbH has announced that its p64 flow modulation device has been granted CE Mark approval. The device is an intraluminal flow diverter intended to treat complex intracranial aneurysms and dissections.
Dr Hermann Monstadt, managing director at phenox, commented, “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 embolisation device that is designed to divert blood flow away from the aneurysm while reconstructing and reinforcing the vessel wall wherein lies the disease. Its 64 nickel titanium wire mesh provide a dense lattice for new skin to re-line the diseased vessel and thus close the opening of the aneurysm and provide 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. The device is only released when the physician is completely satisfied with its placement and effect on the flow in the aneurysm. James Lago, phenox Consultant Vice President for Global Sales and Marketing says “The p64 Flow Modulation Device significantly improves the ease of use for physicians.”
Dr Pedro Lylyk of the ENERI Medical Institute in Buenos Aires who has the world’s largest experience with flow diverters states, “The p64 Flow Modulation Device from phenox represents the 4th 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.” phenox will be conducting a post market surveillance study in 8 centres in 7 countries to capture long term data for up to 24 months post treatment.