GORE® Molding & Occlusion Balloon for Endovascular Aortic Repair Receives Approval in the United States, Japan, and Europe
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)
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
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.
Bliss Integrated Communication for Gore Medical
Liz DeForest, 212-584-5477
Om Business Wire
(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
IFF Announces Pricing of $1,500,000,000 Senior Notes Offering24.9.2018 22:25 | Pressemelding
Regulatory News: International Flavors & Fragrances Inc. (NYSE:IFF) (Euronext Paris: IFF), a leading innovator of sensorial experiences that move the world, today announced that it has priced its public offering of $300,000,000 aggregate principal amount of its 3.400% senior notes due 2020, $400,000,000 aggregate principal amount of its 4.450% senior notes due 2028 and $800,000,000 aggregate principal amount of its 5.000% senior notes due 2048. IFF intends to use the net proceeds from the offering to pay a portion of the consideration for the previously announced merger with Frutarom Industries Ltd. and to pay related fees and expenses. IFF anticipates that the offering will close on September 26, 2018, subject to customary closing conditions. The offering is not contingent upon the consummation of the merger. If the closing of the merger has not occurred on or prior to February 7, 2019, or, if prior to such date, the merger agreement with Frutarom is terminated, IFF will be required t
Iberdrola Recognized as United Nations Global Compact LEAD24.9.2018 21:12 | Pressemelding
Today, Iberdrola, one of the world’s largest utilities and the leading renewable energy producer, is pleased to announce that the Company has been recognized as Global Compact LEAD for demonstrating its ongoing commitment to the United Nations Global Compact and its Ten Principles for responsible business. Announced at UN Headquarters in New York during the UN Global Compact Leaders Summit 2018, Iberdrola was identified as being among the highest-engaged participants of the world’s largest corporate sustainability initiative. Lise Kingo, CEO and Executive Director of the UN Global Compact, said, “LEAD companies represent the highest level of engagement with the UN Global Compact. Achieving the Sustainable Development Goals and creating the world we want will not happen without bold action from the responsible business community. We need companies of all sizes — like the ones recognized today — to improve their performance, no matter where they are on their sustainability journey.” “Sin
Pre-Registration for MapleStory 2 Starts Today24.9.2018 17:00 | Pressemelding
Pre-registration for MapleStory 2, the newest MMORPG adventure in Maple World, is available starting today. From September 24 through October 8, players can sign-up on the MapleStory 2 Pre-Registration site available here and earn exclusive rewards! Pre-registration web rewards will include unique in-game items such as the Roosting Seagull, Rustic Mushcabin Name Tag, and the Dusty Rickshaw. From September 24 through October 8, players can also receive a Mint Body Pillow by retweeting the new Runeblade trailer on Twitter and/or liking on Facebook. In addition to pre-registration, players who purchased a Founder’s Pack can jump into Head Start starting October 1, which will allow them to join MapleStory 2 's vibrant and immersive world ahead of global launch on October 10. Along with beta improvements, Head Start (October 1 - October 10) will include: Character progression that carries over to the official launch 6 character slots Founder’s Pack items Access to Gemstones Lv. 1 - 50 Quest
First Engineering Faculty in Canada Named after a Woman: Business Leader Gina Cody Makes Historic $15 Million Donation to Montreal’s Concordia University24.9.2018 15:15 | Pressemelding
Three decades after becoming the first woman to earn a PhD in building engineering from Concordia University, Gina Parvaneh Cody, MEng 81, PhD 89, has made history by giving $15 million to her alma mater. In recognition of her transformative gift to the “Campaign for Concordia: Next-Gen. Now”, the university has named its faculty of engineering and computer science after the alumna. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20180924005425/en/ (Photo: Business Wire) The Gina Cody School of Engineering and Computer Science is the first engineering faculty in Canada — and one of the first internationally — to be named after a woman. Gina Cody, a top business leader and building engineer, credits much of her success to Concordia because the university provided her with an entrance scholarship. “I arrived in Canada as a young student from Iran in 1979 with $2,000,” she says. “Concordia welcomed me and provided me with support
Dole’s Standard Fruit Celebrates 20-Year Milestone as Environmental Leader24.9.2018 15:00 | Pressemelding
Earlier in September Dole Food Company participated in a celebration of the twentieth anniversary of the company’s initial receipt of its ISO 14001 Certification. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20180924005079/en/ Dole Fresh Fruit President Renato Acuña speaks at the anniversary celebration of Dole's landmark environmental sustainability certification. (Photo: Business Wire) On July 2, 1998, Standard Fruit Company of Costa Rica S.A., a subsidiary of Dole Food Company, Inc., became the first agricultural and banana company in the world to receive the globally recognized ISO 14001 Certification for its environmental management policy and the establishment of its Integrated Management System. With the certification, the company further strengthened its robust Environmental Management System, with results that place it at the forefront in the sustainable production of bananas and pineapples. The celebration event, h
Helsinki Joins New York in Commitment to Review Local Progress Toward Global Sustainable Development Goals24.9.2018 14:42 | Pressemelding
In July 2018, the City of New York became the first city in the world to submit to the United Nations its progress toward the Sustainable Development Goals (SDG’s) on city level. As the first European city Helsinki will follow New York City and become the second city in the world in effort to showcase crucial role of cities in achieving UN agenda for people, prosperity and planet. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20180924005633/en/ As the first European city Helsinki will follow New York City and become the second city in the world in effort to showcase crucial role of cities in achieving UN agenda for people, prosperity and planet. Photo: Jussi Hellsten The Mayor of Helsinki Jan Vapaavuori announced Helsinki’s commitment to the voluntary local review at a panel conversation with New York City’s Commissioner of International Affairs Penny Abeywardena at the Social Good Summit in New York City on Sunday. Even thou