Business Wire

CERENOVUS Receives European Regulatory Approval For BRAVO Flow Diverter to Treat Intracranial Aneurysms.

Del

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.

This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20180808005446/en/

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.

- ENDS -

About CERENOVUS
CERENOVUS, part of the Johnson & Johnson Medical Devices Companies, is a global leader in neurovascular care. Our commitment to changing the trajectory of stroke is inspired by our long heritage and dedication to helping physicians protect people from a lifetime of hardship. CERENOVUS offers a broad portfolio of devices used in the endovascular treatment of hemorrhagic and ischemic stroke.

About the Johnson & Johnson Medical Devices Companies
The Johnson & Johnson Medical Devices Companies' purpose is to reach more patients and restore more lives. Having advanced patient care for more than a century, these companies represent an unparalleled breadth of products, services, programs and research and development capabilities in surgical technology, orthopaedics, cardiovascular and specialty solutions with an offering directed at delivering clinical and economic value to health care systems worldwide.

References

1. 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.

2. 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.

© CERENOVUS 2018. All rights reserved.095543-180723

Contact information

CERENOVUS
REBECCA RATCLIFFE
+44 (0) 7825 378894

Om Business Wire

Business Wire
Business Wire
24 Martin Lane
EC4R 0DR London

+44 20 7626 1982http://www.businesswire.co.uk

(c) 2018 Business Wire, Inc., All rights reserved.

Business Wire, a Berkshire Hathaway company, is the global leader in multiplatform press release distribution.

Følg saker fra Business Wire

Registrer deg med din epostadresse under for å få de nyeste sakene fra Business Wire på epost fortløpende. Du kan melde deg av når som helst.

Siste saker fra Business Wire

Fantastec Joins Forces with Arsenal FC Launching Official Blockchain Collectibles App22.2.2019 14:30:00Pressemelding

Fantastec announced today its first football licensing agreement with Premier League club Arsenal FC for a new blockchain authenticated collectibles app called Fantastec SWAP. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20190222005277/en/ Arsenal players appear on Fantastec SWAP in official licensing deal (Graphic: Business Wire) London-based Fantastec is a leading sports fan technology innovator, and its blockchain based ‘SWAP’ app will have broad appeal to global sports fans, gamers and sports card collectors alike. Fantastec SWAP unlocks unique and authentic club content through the app, like player autographs and exclusive footage. With its innovative blockchain technology, fans around the world can now discover, collect and swap officially licensed club collectibles with other fans with complete trust. “Fantastec SWAP is a game-changer for international football fans as well the sports collectibles industry,” commented

Volkswagen Protects Virtual Key Sharing App with Trustonic Application Protection22.2.2019 13:42:00Pressemelding

Volkswagen is working with mobile cyber security leader Trustonic to enable customers to use smartphones to access their vehicles, and to securely share their digital car keys to grant access to others via a smartphone app. Volkswagen is using the Trustonic Application Protection (TAP) platform to secure the mobile app and ensure that sensitive information and key transfer requests are securely displayed to, and approved by, a real authenticated user on a trusted device and not by hackers or malware simulating a user or device. “The smartphone is becoming the vehicle key of the future and our We Connect service is the interface for this today in the new Volkswagen Passat,” comments Alf Pollex, Head of Infotainment and Connected Car at Volkswagen AG. “The user installs the We Connect app on their smartphone which is then authorized via the infotainment system with a Transaction Number. The Mobile Key will be compatible with Android-based Samsung devices. No mobile network connection is

Mundipharma EDO GmbH: US FDA grants Orphan Drug Designation for etoposide toniribate in relapsed/refractory biliary tract cancer22.2.2019 13:30:00Pressemelding

Mundipharma EDO GmbH, part of the Mundipharma network of independent associated companies, and Imbrium Therapeutics L.P., an operating subsidiary of Purdue Pharma L.P., today announced that the US FDA has granted Orphan Drug Designation (ODD) to etoposide toniribate for the treatment of relapsed/refractory biliary tract cancer, also known as cholangiocarcinoma.3 This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20190222005126/en/ Biliary tract cancer is a rare tumour with approximately 8,000 patients diagnosed in the US every year and 10,571 in Europe.4,5 The FDA grants ODD status to medicines intended for the treatment, diagnosis or prevention of rare diseases or disorders that affect fewer than 200,000 people in the US. Radical surgery is the only curative treatment for biliary tract cancer but, in most cases, the cancer is inoperable. Patients who fail first-line chemotherapy have limited treatment options and the standard of

Lenovo Data Center Group Delivers Broad Edge Computing Portfolio, Expands Investments in IoT22.2.2019 13:13:00Pressemelding

Next week at MWC Barcelona, Lenovo Data Center Group (DCG) will showcase continued investments in its solutions supporting IoT and edge computing as part of its IoT growth plan over the next few years. Building on the momentum of its fifth consecutive quarter of profit growth, Lenovo DCG is building a portfolio that takes infrastructure to where the data is, whether that be in the traditional data center, in the cloud or increasingly, at the edge. Today, around 10 percent of enterprise-generated data is created and processed outside a traditional centralized data center or cloud. By 2022, Gartner predicts this figure will reach 75 percent. This migration is driving increased concerns around data privacy, security and regulations coupled with challenges of latency, bandwidth and downtime. Lenovo is addressing these challenges by creating a broad portfolio of edge computing offerings that address the different ways that customers want to deploy edge computing solutions for IoT use cases.

Entrust Datacard to Acquire Market-Leading General Purpose Hardware Security Module Business from Thales22.2.2019 09:47:00Pressemelding

Entrust Datacard, a leading provider of trusted identity and secure issuance technology solutions, today announced that the company has signed a definitive agreement to acquire Thales’s market-leading General Purpose Hardware Security Module (GP HSM) business, nCipher Security, which has been operating as a separate stand-alone business within Thales since January 2019. Thales is divesting its nCipher GP HSM business, in accordance with Regulatory Clearances necessary to complete Thales’s forthcoming and previously-announced acquisition of Gemalto and to ensure a strong competitive market leader in the HSM market. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20190222005135/en/ General Purpose HSMs are a core component of Entrust Datacard’s solutions and are an underlying part of the security infrastructure of the company’s public key infrastructure (PKI) and secure socket layer (SSL) offerings. The acquisition will allow the

Turkcell and US RAN Vendor Airspan Are Laying the Foundation for 5G with an Ultra-Dense AirDensity Network to Support Turkey’s Digital Transformation22.2.2019 09:06:00Pressemelding

Turkcell and Airspan announce the first deployment of AirDensity to deliver coverage and capacity to the most constrained indoor locations in Turkey as well as extending coverage to rural areas and enabling development of next generation solutions including Drone-based flying cells. AirDensity is based on the multi-award-winning AirUnity platform and part of the Airspan network densification portfolio that counts approximately half a million 4G cells deployed world-wide. This is further proof of the progress of the Feb 23, 2017 strategic cooperation announcement between Turkcell and Airspan. Airspan supports the ‘Made in Turkey’ 5G consortium with an R&D center in the Istanbul Technopark and provides regional support for Airspan’s deployments. Turkcell is deploying AirDensity is the innovative all-wireless small cell to deliver world class user experience to its residential and enterprise customers, develop innovative vertical applications and remain Turkey’s leading digital operator.