Business Wire

GORE® Molding & Occlusion Balloon for Endovascular Aortic Repair Receives Approval in the United States, Japan, and Europe

Del

W. L. Gore & Associates, Inc. (Gore) announced FDA 510(k) clearance, approval from the Japanese Ministry of Health, Labour, and Welfare, and receipt of CE Mark for the innovative GORE® Molding & Occlusion Balloon, a compliant polyurethane balloon catheter designed in close collaboration with clinicians to assist in the expansion of self-expanding stent grafts or to temporarily occlude large-diameter vessels. The new device meets all endovascular aortic repair (EVAR) procedural requirements – a single balloon that replaces the need for multiple molding and occlusion balloons.

This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20180823005068/en/

GORE® Molding & Occlusion Balloon (Photo: Business Wire)

GORE® Molding & Occlusion Balloon (Photo: Business Wire)

The device’s proven radial expansion force across the range of EVAR device sizes enables physicians to consistently seat and seal grafts with confidence. This more efficient graft seal may reduce procedural time and the risk of Type 1 endoleaks. The device is also engineered with the lowest profile to reduce the potential of access-related complications, and its excellent pushability and trackability offers enhanced control with uncompromised inflation and deflation time.

“We have worked closely with clinicians to engineer a single balloon that truly changes both the physician and the patient experience,” said Eric Zacharias, Gore Vascular Business Leader. “This milestone is one of several in our ongoing dedication to treating the entire aorta, and to helping physicians offer the best patient experience possible.”

The new device is supplied in a single catheter length of 90 cm to enable use with current GORE® EXCLUDER® Devices as well as future Gore devices while still being compatible with a 180 cm length guidewire.

Besides adding value through consistently reliable technical success and patient experience, the use of a single balloon allows for efficiency and inventory optimization. “We know our physicians are concerned with both technical performance and with economic value to their practices,” Zacharias said. “Use of a single molding and occlusion balloon during an EVAR case reduces intraoperative waste, minimizing overall instrument cost per procedure. The potential to reduce operating room and catheter lab time may contribute to faster room turnover and more on-time procedural starts.”

The GORE Molding & Occlusion Balloon is part of the growing family of endovascular products that share a mission to effectively treat aortic disease, backed by Gore’s highly rated clinical support teams and educational offerings. The comprehensive portfolio of aortic products includes the GORE® EXCLUDER® AAA Endoprosthesis; the Conformable GORE® TAG® Thoracic Endoprosthesis for the treatment of thoracic aneurysms, transections, and Type B dissections; and the GORE® EXCLUDER® Iliac Branch Endoprosthesis, the only FDA approved off-the-shelf device indicated for the endovascular treatment of common iliac artery aneurysms or aortoiliac aneurysms.

For more information, visit www.goremedical.com/balloon

For complete indications and other important safety information for Gore commercial products referenced herein, refer to the applicable Instructions for Use (IFU).

Medical Products Division

Gore engineers devices that treat a range of cardiovascular and other health conditions. With more than 40 million medical devices implanted over the course of more than 40 years, Gore builds on its legacy of improving patient outcomes through research, education and quality initiatives. Product performance, ease of use and quality of service provide sustainable cost savings for physicians, hospitals and insurers. Gore is joined in service with clinicians and through this collaboration we are improving lives. www.goremedical.com

About Gore

W. L. Gore & Associates is a global materials science company dedicated to transforming industries and improving lives. Founded in 1958, Gore has built a reputation for solving complex technical challenges in the most demanding environments — from revolutionizing the outerwear industry with GORE-TEX® fabric to creating medical devices that improve and save lives to enabling new levels of performance in the aerospace, pharmaceutical and mobile electronics markets, among other industries. The company is also known for its strong, team-oriented culture and global recognition from the Great Place to Work® Institute. Headquartered in Newark, Del., Gore employs 9,500 Associates and generates annual revenues of $3.5 billion. www.gore.com

Products listed may not be available in all markets.
GORE ® , GORE-TEX ® , EXCLUDER ® , TAG ® , are trademarks of W. L. Gore & Associates.

Contact information

Media:
Bliss Integrated Communication for Gore Medical
Liz DeForest, 212-584-5477
liz@blissintegrated.com

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

Hilton Launches New Brand, Signia Hilton, Delivering Sophisticated Travel While Reimagining Meetings and Events22.2.2019 17:00:00Pressemelding

Hilton (NYSE: HLT) today announced the launch of Signia Hilton, its dynamic, new meetings-and-events-focused brand. The portfolio of hotels is setting out to transform the industry for meeting professionals and sophisticated business travelers by infusing state-of-the-art technology and design into every aspect of the guest experience. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20190222005071/en/ The brand further reinforces Hilton’s commitment to innovation that meets the evolving needs of today’s travelers and will bring premium experiences to top urban and resort destinations around the world. “In our 100th year of hospitality, we are more focused than ever on providing exceptional experiences to all of our guests – and that includes evolving those experiences to meet their changing needs,” said Christopher J. Nassetta, president and CEO, Hilton. “We are proud to launch Signia Hilton, which exemplifies our innovative sp

Axonics® Granted Expanded CE Mark Label; First and Only Sacral Neuromodulation System Approved for Use with Full-Body MRI Scans22.2.2019 16:30:00Pressemelding

Axonics Modulation Technologies, Inc. (NASDAQ: AXNX), a medical technology company focused on the development and commercialization of novel implantable Sacral Neuromodulation (“SNM”) devices for the treatment of urinary and bowel dysfunction, announced today that it has received CE mark approval for 1.5T and 3T full-body magnetic resonance imaging (“MRI”) conditional labeling for the Axonics r-SNM® System. The Axonics r-SNM System is the only implantable SNM system that has received full-body MRI conditional labeling for sale in Europe1. Raymond W. Cohen, Chief Executive Officer of Axonics, said, “Without this labeling, any patient requiring an MRI scan on any body part below the head must have their neurostimulator surgically explanted prior to the MRI scan, resulting in an additional surgery for the patient and additional costs to patients and the healthcare system. This authorization of full-body MRI scans in Europe is another important milestone for Axonics, differentiating our te

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.