CERENOVUS Receives European Regulatory Approval For BRAVO Flow Diverter to Treat Intracranial Aneurysms
A global leader in neurovascular intervention demonstrates commitment to advance patient care by entering flow diverter market.
Brussels, Belgium – August 8, 2018. CERENOVUS, part of the Johnson & Johnson Medical Devices Companies, announced today it has received European CE mark approval for its BRAVO Flow Diverter. The device is approved for use in the treatment of patients suffering from intracranial aneurysms. The device will divert blood flow from the aneurysm and promote healing thereby reducing the risk of rupture, a main cause of hemorrhagic stroke.
The BRAVO Flow Diverter marks CERENOVUS’ entry into the flow diverter category, adding to its broad portfolio of devices used in endovascular treatment of hemorrhagic and ischemic stroke. The innovative design of the device aims to improve clinician ease of use, improve cost effectiveness and reduce length of procedure.
“Flow diverters are now widely used and for many, have become the go to option for the treatment of complex aneurysms” explains Professor Patrick Brouwer Senior Consultant Neurointerventionalist at Karolinska University Hospital and Evaluator for BRAVO Flow Diverter. “I believe the design of the BRAVO Flow Diverter, particularly the proximal and distal expansion rings, provides a fresh approach to treat aneurysms.”
Stroke is a devastating disease that strikes 15 million people each year,1 with hemorrhagic strokes accounting for 13%2 of all strokes. Aneurysms are a main cause of hemorrhagic strokes and occur when a weakened region of a blood vessel balloons until it ruptures and bleeds into the brain.2
“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” said Daniella Cramp, CERENOVUS Worldwide President. “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 are scheduled to take place across Europe ahead of European commercialization.
The device is currently not approved for use in the United States.
- The Economist Intelligence Unit (2016) Addressing the global stroke burden. [Online]. https://perspectives.eiu.com/sites/default/files/Addressingtheglobalstrokeburden_0.pdf. Last accessed May 2, 2018.
- American Stroke Association (2018) Hemorrhagic Strokes (Bleeds). [Online]. http://www.strokeassociation.org/STROKEORG/AboutStroke/TypesofStroke/HemorrhagicBleeds/Hemorrhagic-Strokes-Bleeds_UCM_310940_Article.jsp#.WypwpFVKjIW. Last accessed June 20, 2018.