Cerenovus, part of the Johnson & Johnson Medical Devices Companies, has received European CE mark approval for its BRAVO Flow Diverter device, which can be used to treat patients suffering from intracranial aneurysms.
The device is designed to divert blood flow from an aneurysm, reducing the risk of rupture and a potential haemorrhagic stroke.
The BRAVO Flow Diverter is now among Cerenovus’s broad portfolio of devices used in endovascular treatment of haemorrhagic and ischaemic stroke. Its design aims to improve clinician ease of use and cost-effectively reduce the length of procedures.
Professor Patrick Brouwer, a senior consultant neurointerventionalist at Karolinska University Hospital in Sweden, evaluated the BRAVO Flow Diverter. He said: “Flow diverters are now widely used and, for many, have become the go-to option for the treatment of complex aneurysms. I believe the design of the BRAVO Flow Diverter, particularly the proximal and distal expansion rings, provides a fresh approach to treat aneurysms.”
Stroke affects 15 million people each year worldwide, according to the World Heart Federation, with haemorrhagic strokes accounting for 13% of all cases. The main cause of a haemorrhagic stroke is an aneurysm which occurs when a weakened region of a blood vessel expands until it ruptures and then bleeds into the brain.
Cerenovus worldwide president Daniella Cramp said: “The BRAVO Flow Diverter builds on our legacy of providing meaningful innovation to enable patients to live a life free from the burden of stroke. Our entry into the flow diverter market demonstrates our commitment to push the boundaries of stroke treatment and marks a key step towards changing the trajectory of stroke.”
Early evaluations will occur across Europe ahead of the European commercialisation of the device, which is currently not approved for use in the US.