First Patient in Europe Receives Implant of GORE® EXCLUDER® Conformable AAA Endoprosthesis with ACTIVE CONTROL System and Enrolls in Post-Market Registry
W. L. Gore & Associates, Inc. (Gore) today announced the first European patient implant of the GORE® EXCLUDER® Conformable AAA Endoprosthesis with ACTIVE CONTROL System. This next-generation endovascular aneurysm repair (EVAR) device is indicated to treat the broadest range of abdominal aortic aneurysms (AAA) in patients with challenging anatomies. Physicians now have an EVAR solution designed to treat patients previously excluded due to challenging proximal aortic necks.
This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20180917005087/en/
GORE® EXCLUDER® Conformable AAA Endoprosthesis with ACTIVE CONTROL System (Graphic: Business Wire)
The GORE EXCLUDER Conformable AAA Endoprosthesis with ACTIVE CONTROL System is CE Mark approved for patients with proximal aortic neck angles of up to 90 degrees with a minimum 15 mm aortic neck length or in patients with proximal aortic neck angles of up to 60 degrees with a 10 mm minimum aortic neck length.
The successful procedure took place on September 11 at Catharina Hospital in Eindhoven, Netherlands by Marc van Sambeek, MD. The patient was also the first enrollment in an investigator initiated post-market European registry, known as EXCeL (EXcluder Conformable real Life), of which Prof. van Sambeek is the principal investigator.
“Before this device, EVAR was reserved for patients whose aorta fell within a standard shape and size,” said Prof. van Sambeek. “The conformability of the new GORE EXCLUDER Conformable Device in combination with the angulation control of the new delivery system will allow us to offer a less invasive, lower-risk alternative to open surgery to more AAA patients than ever before. The EXCeL registry will track the real-world effectiveness and safety of the device, and I look forward to enrolling additional patients with challenging, highly angulated aortic anatomies and seeing the long-term value of this device.”
The EXCeL registry will enroll 150 patients from up to 11 European sites. Data from the registry will assess safety and treatment success of the GORE EXCLUDER Conformable AAA Device for the treatment of infrarenal AAA in a broad range of anatomic presentations. The device is also currently being evaluated in a pivotal investigational U.S. study, in which the first patient was enrolled on December 19, 2017.
The GORE EXCLUDER Conformable AAA Device builds on the proven clinical performance of the GORE® EXCLUDER® AAA Endoprosthesis, which represents over 20 years of worldwide experience and more than 300,000 patients treated*, a history unmatched by currently available AAA stent grafts. The new device leverages the limb design of the GORE EXCLUDER Device which has demonstrated exceptional clinical performance as evidenced by 0.5% limb occlusion through 3-year follow-up.** The limbs, a unique combination of proprietary ePTFE graft material and a fully supported, nested, nitinol stent, are designed to prevent kinking and occlusion.
The new device introduces the GORE® ACTIVE CONTROL System in AAA treatment. This new delivery system includes a conformable stent graft, enhanced device positioning, and optional angulation control. To enhance positioning, the device is deployed partially constrained and the physician has the option to reconstrain the proximal end of the device to aide in achieving optimal device placement. During the deployment process, the physician may use the optional angulation control to angle the device to achieve orthogonal placement to the aortic blood flow lumen and to maximize device conformability and seal.
“With this first implant in Europe, we are continuing our commitment to offer the broadest and most technically advanced endovascular treatment capabilities to physicians and their patients,” said Eric Zacharias, Vascular Business Leader. “We are dedicated to developing technology that enables physicians to better treat challenging aortic anatomies. By collaborating with physicians, we’ve evolved our market-leading GORE EXCLUDER Device to enable more patients to be treated with EVAR.”
The GORE EXCLUDER Conformable AAA Device 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 team and educational offerings.† The comprehensive portfolio of products also includes the GORE® TAG® Conformable Thoracic Stent Graft with ACTIVE CONTROL System for the treatment of thoracic aneurysms, transections, and Type B dissections; the GORE® EXCLUDER® Iliac Branch Endoprosthesis, the first complete, all-in-one system approved in Europe for the endovascular treatment of common iliac artery aneurysms or aortoiliac aneurysms; and the GORE® VIABAHN® VBX Balloon Expandable Endoprosthesis for treatment of de novo or restenotic lesions, including lesions at the aortic bifurcation.
* Based on the number of Trunk-Ipsilateral Legs distributed.
** GREAT. n = 3,273. To calculate the overall event rates from procedure through end of study period, all subjects who could have had events, regardless of length of follow-up, were included. For outcome data, GREAT only collects site reported serious adverse events.
† 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 W. L. GORE & ASSOCIATES
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 ® , ACTIVE CONTROL, EXCLUDER ® , TAG ® , VBX, and VIABAHN ® are trademarks of W. L. Gore & Associates. AX0416-EN1 SEPTEMBER 2018
Bliss Integrated Communication for Gore Medical
Liz DeForest, 212-584-5477
For more than 50 years, Business Wire has been the global leader in press release distribution and regulatory disclosure.
Tilaa tiedotteet sähköpostiisi
Haluatko tietää asioista ensimmäisten joukossa? Kun tilaat mediatiedotteemme, saat ne sähköpostiisi välittömästi julkaisuhetkellä. Tilauksen voit halutessasi perua milloin tahansa.
Lue lisää julkaisijalta Business Wire
Warm welcome for ABB Formula E in Davos19.1.2019 12:00 | Tiedote
Just a few days before the start of the World Economic Forum 2019, Davos is celebrating a world premiere: The latest ABB FIA Formula E racing car - dubbed Gen2 – was transported on a train from the iconic Swiss Rhaetian Railway to Europe’s highest city, where it will be an exciting eyecatcher during the coming week at the Davos Platz railway station. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20190119005003/en/ ABB FIA Formula E racing car in Davos (Photo: Business Wire) From this Saturday until next Sunday, January 27, the Gen2 will be on display in a special glass case. Interested passersby can learn about the ABB FIA Formula E racing series as well as about the activities of ABB in e-mobility via an information system. With over 8,500 fast charging stations installed in 70 countries around the world, ABB is the global market leader for charging infrastructures. To watch the video, click here ABB (ABBN: SIX Swiss Ex) is
PMI’s Mission Winnow Goes Full Throttle with Ducati Corse for 2019 MotoGP™18.1.2019 20:00 | Tiedote
Philip Morris International Inc. (PMI) (NYSE: PM) is pleased to announce that its Mission Winnow initiative is expanding in 2019 to include the Ducati Corse racing team. Mission Winnow is a PMI-led campaign to raise global awareness of our passion and determination to constantly improve and evolve, as well as highlight the power of science, technology and innovation to build a better future. PMI has partnered with Ducati Corse since 2002 and has extended the relationship for another three years until the end of 2021. As of the start of this year’s MotoGP season, the team will be officially known as Mission Winnow Ducati. Mission Winnow was first launched in October 2018 with Scuderia Ferrari Mission Winnow, which – like Ducati Corse – has a passion for innovation and a relentless drive to improve in the team’s pursuit of victory. Ducati Corse is one of the most inspiring and resilient teams in MotoGP, with a 70-year history in racing. Ducati fans form a passionate community who appreci
IFF’s Frutarom Division Completes Acquisition of 60% of Thailand-based Mighty18.1.2019 15:50 | Tiedote
Regulatory News: International Flavors & Fragrances Inc. (NYSE:IFF) (Euronext Paris:IFF) (TASE:IFF), announced that its Frutarom Division has completed the acquisition of 60% of the share capital of The Mighty CO. LTD. (“Mighty”), a leading savory solutions provider in Thailand, thus continuing its growth strategy in Southeast Asia. Amos Anatot, President of IFF's Frutarom Division, said, “The completion of this deal with Mighty underscores that the Frutarom division will continue on its growth strategy and pursue attractive companies that create new opportunities or build on current capabilities.” Mr. Anatot continued, “And in this case, we are helping to grow our capabilities in savory solutions – already an area of strength for legacy Frutarom, now IFF." Mighty, founded in 1989, develops, produces and markets reaction flavors, with particular expertise in savory solutions. The company’s portfolio includes flavors, seasoning blends, marinades, and specialty functional raw materials f
LTI Q3 FY19: Constant currency revenue growth up 6.1% QoQ and 20.6% YoY; Net Profit jumps 32.8% YoY18.1.2019 15:02 | Tiedote
Larsen & Toubro Infotech (BSE code: 540005, NSE: LTI), a global technology consulting and digital solutions company, announced its Q3 FY19 results today. In US Dollars: Revenue at USD 346.9 million; growth of 5.6% QoQ and 18.2% YoY Constant Currency Revenue growth of 6.1% QoQ and 20.6% YoY In Indian Rupees: Revenue at Rs 24,729 million; growth of 6.1% QoQ and 31.3% YoY Net Income at Rs 3,755 million; growth of (6.2%) QoQ and 32.8% YoY “We are pleased to deliver another strong quarter with 5.6% QoQ growth in USD revenues. Our broad-based revenue growth, superior margin delivery and steady cash generation in Q3 is a testimony of our focused execution and client centricity. We are also thrilled to welcome Ruletronics to LTI family. Ruletronics enables businesses to transform and evolve digitally by providing innovative BPM and CRM solutions leveraging Pega Platform.” - Sanjay Jalona, Chief Executive Officer & Managing Director, LTI Recent Deal Wins Nets, the leading payments company in th
Schlumberger Announces Full-Year and Fourth-Quarter 2018 Results18.1.2019 15:00 | Tiedote
Schlumberger Limited (NYSE: SLB) today reported results for full-year 2018 and the fourth quarter of 2018. (Stated in millions, except per share amounts) Full-Year Results Twelve Months Ended Change Dec. 31, 2018 Dec. 31, 2017 Year-on-year Revenue $32,815 $30,440 8% Pretax operating income $4,187 $3,921 7% Pretax operating margin 12.8% 12.9% -12 bps Net income (loss) - GAAP basis $2,138 $(1,505) n/m Net income, excluding charges & credits* $2,261 $2,085 8% Diluted EPS (loss per share) - GAAP basis $1.53 $(1.08) n/m Diluted EPS, excluding charges and credits* $1.62 $1.50 8% Full-Year Consolidated Revenue by Area North America $11,984 $9,487 26% Latin America 3,745 3,976 -6% Europe/CIS/Africa 7,158 7,072 1% Middle East & Asia 9,543 9,394 2% Other 385 511 n/m $32,815 $30,440 8% North America revenue $11,984 $9,487 26% International revenue $20,446 $20,442 - North America revenue, excluding Cameron $9,668 $7,518 29% International revenue, excluding Cameron $17,675 $17,423 1% *These are non
FLIR Systems Awarded $89 Million Contract from French Armed Forces to Deliver Black Hornet Personal Reconnaissance System18.1.2019 14:00 | Tiedote
FLIR Systems, Inc. (NASDAQ: FLIR) announced today it has been awarded a contract from the French Defense Procurement Agency (DGA) in support of the French Operational Pocket Drone (DrOP) program. The contract has a ceiling value of $89 million to provide the FLIR Black Hornet® 3 nano-unmanned aerial vehicle (UAV) and Personal Reconnaissance System (PRS) to support French Armed Forces operations. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20190118005085/en/ The French Armed Forces awarded FLIR Systems a contract to deliver the Black Hornet Personal Reconnaissance System for military operations. (Photo: Business Wire) The Black Hornet PRS is the world’s smallest combat-proven nano-Unmanned Aerial System (UAS) and is currently deployed in more than 30 countries. The Black Hornet enables the warfighter to maintain situational awareness, threat detection, and surveillance no matter where the mission takes them. Equipped with el
Uutishuoneessa voit lukea tiedotteitamme ja muuta julkaisemaamme materiaalia. Löydät sieltä niin yhteyshenkilöidemme tiedot kuin vapaasti julkaistavissa olevia kuvia ja videoita. Uutishuoneessa voit nähdä myös sosiaalisen median sisältöjä. Kaikki STT Infossa julkaistu materiaali on vapaasti median käytettävissä.Tutustu uutishuoneeseemme