Business Wire

GORE® VIABAHN® Endoprosthesis Found to Provide Superior Patency and Reduced Interventions Versus Balloon Angioplasty Alone for Challenging AV Access Cases

Del

W. L. Gore & Associates (Gore) today announced the publication of clinical study results from the Gore REVISE Clinical Study* in the Journal of Vascular Surgery (J Vasc Surg) detailing the success of the GORE® VIABAHN® Endoprosthesis with Heparin Bioactive Surface** (GORE VIABAHN Endoprosthesis) in AV access graft outflow interventions. Overall, the device performed significantly better compared to percutaneous transluminal angioplasty (PTA) alone for treatment of challenging AV access cases in a real-world patient population, both in terms of primary patency and in number of interventions over the study period. Notably, the Gore REVISE Clinical Study is the first AV access stent-graft study to include patients with thrombosed grafts and placement of the device across the elbow joint, further demonstrating the utility of the GORE VIABAHN Endoprosthesis in this demanding clinical application.

This Smart News Release features multimedia. View the full release here: http://www.businesswire.com/news/home/20160628005462/en/

GORE® VIABAHN® Endoprosthesis (Photo: Business Wire)

GORE® VIABAHN® Endoprosthesis (Photo: Business Wire)

Key findings from the Gore REVISE Clinical Study:

  • The device delivered a 47 percent improvement in target lesion primary patency and a 48 percent improvement in circuit primary patency over PTA alone at six months.
  • The device demonstrated a 50 percent increase over PTA in target lesion primary patency at six months when treating thrombosed AV access circuits.
  • When placed across the elbow, the GORE VIABAHN Endoprosthesis delivered 72 percent target lesion primary patency at six months and 83 percent access secondary patency at 24 months (n=22).
  • The Gore REVISE Clinical Study also showed median time to target lesion reintervention or graft abandonment with GORE VIABAHN Endoprosthesis was approximately twice that achieved with PTA (203 versus 108 days).
  • Placement of GORE VIABAHN Endoprosthesis led to 27 percent fewer interventions both at the target lesion and in the dialysis access circuit over a 24-month period compared to PTA.

According to the United States Renal Data System,*** there are over 700,000 patients with end-stage renal disease (ESRD) and nearly 90 percent of those patients are receiving hemodialysis. Arteriovenous grafts (AVG) are often used to create dialysis circuits for patients. Failing dialysis circuits often result in the placement of infection-prone central venous catheters (CVCs) while a new dialysis access circuit is surgically created and matured. Balloon angioplasty is a common fix in the event of a failing circuit, but many patients are unresponsive to the procedure, which has left a gap in treatment capabilities for difficult anatomies. The Gore REVISE Clinical Study demonstrated that placement of a stent-graft leads to better patient outcomes with reduced interventions, a positive finding for all stakeholders involved in the patient’s care.

“Patients with failing dialysis circuits that are unresponsive to balloon angioplasty are a real problem for physicians. Historically, angioplasty has been a popular treatment option, but our study found its six-month primary patency rates to be well below the ‘reasonable goal’ of 50 percent stated by the 2006 K/DOQI Guidelines for Vascular Access,” said Thomas Vesely, MD, an Interventional Radiologist from the Vascular Access Services in St. Louis, Mo., and the primary author of the JVS paper. “The data shown in the Gore REVISE Clinical Study manuscript makes a compelling argument for GORE VIABAHN Endoprosthesis use in those challenging cases.”

In 2013, the Food and Drug Administration (FDA) granted indication for the GORE VIABAHN Endoprosthesis to maintain and salvage failing dialysis access circuits. The Gore device is the lowest profile, most flexible, self-expanding, small-diameter endoprosthesis available and the only stent or stent-graft to receive approval for the superficial femoral artery (SFA), in-stent restenosis of bare-metal stents in the SFA, iliac artery, and AV access. It is constructed with a durable, reinforced, biocompatible, expanded polytetrafluorethylene (ePTFE) liner and attached to an external nitinol stent structure. The GORE VIABAHN Endoprosthesis also features Gore's CBAS Heparin Surface, the proven, lasting heparin bonding technology designed to resist thrombus formation.

“The Gore REVISE Clinical Study was the clinical support used to gain the U.S. on-label indication for GORE VIABAHN Endoprosthesis in AV access,” said Ray Swinney, Business Unit Leader for the Gore Peripheral Interventional Business Unit. “By expanding indications to include AV access, GORE VIABAHN Endoprosthesis continues to show how physicians can depend on the device for complete coverage in complex cases.”

For more information about the Gore REVISE Clinical Study and the success of the GORE VIABAHN Endoprosthesis in AV access graft outflow interventions, the Journal of Vascular Surgery article can be viewed online at http://www.jvascsurg.org/article/S0741-5214(16)30175-6/fulltext.

* Vesely T, DaVanzo W, Behrend T, Dwyer A, Aruny J. Balloon angioplasty versus Viabahn stent graft for treatment of failing or thrombosed prosthetic hemodialysis grafts. Journal of Vascular Surgery. In press.

** Heparin Bioactive Surface is synonymous with the CBAS Heparin Surface

*** Gilbertson DT, Liu J, Xue JL, Louis TA, Solid CA, Ebben JP, Collins AJ. Projecting the number of patients with end-stage renal disease in the United States to the year 2015. Journal of the American Society of Nephrology 2005;16(12):3736-3741.

Products listed may not be available in all markets. GORE® and VIABAHN® are trademarks of W. L. Gore & Associates. CBAS is a trademark of Carmeda AB, a wholly owned subsidiary of W. L. Gore & Associates, Inc.

ABOUT US

At Gore Medical, we have provided creative therapeutic solutions to complex medical problems for 40 years. During that time, 40 million innovative Gore Medical devices have been implanted, saving and improving the quality of lives worldwide. Our extensive family of products includes vascular grafts, endovascular and interventional devices, surgical meshes for hernia and soft tissue reconstruction, staple line reinforcement materials, and sutures for use in vascular, cardiac and general surgery. We are one of a select few companies to appear on all of the U.S. “100 Best Companies to Work For” lists since the rankings debuted in 1984. For more information, visit www.goremedical.com.

Contact information

Chempetitive Group for W. L. Gore & Associates
Andrea Vuturo, +1-312-997-2436
GoreMedical@Chempetitive.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

Tempo Grows Revenue by 38% in 2017 to $17.9 Million19.2.2018 11:14Pressemelding

Tempo, creator of efficiency-enhancing project management software solutions for Atlassian’s Jira platform, announced strong results for its 2017 fiscal year ending December 31, 2017. “2017 marks another productive and successful year for Tempo, with December our highest grossing month ever and sales across our product range exceeding expectations,” commented Agust Einarsson, CEO, “The completion of our new cloud infrastructure and successful migration of our entire customer base to Amazon Web Services (AWS) marks a strategic milestone, empowering Tempo with a more scalable underlying platform and enabling us to deploy products to customers faster.” Highlights for 2017 include: Revenue grew 38% year-over-year to US$17.9 million Almost 2,000 new customers were acquired Launched our new cloud infrastructure Expanded product footprint beyond the Atlassian environment with Tempo for Slack North American operations continued to grow More than 120 partners worldwide Celebrated our 10-year an

Morrow Sodali Announces Appointment of David Shammai as Corporate Governance Director - Cross Border19.2.2018 10:05Pressemelding

Morrow Sodali today announced that David Shammai has joined the firm as Corporate Governance Director - Cross Border. David joins from APG Asset Management, the Dutch pension fund manager, where in his role as senior corporate governance specialist he was involved in voting, policy, and engagement. Based in the London office, David will focus on the firm’s growing corporate governance activities across its European offices. Together with Morrow Sodali’s expanding team of corporate governance professionals, David will work to further develop the firm’s governance services – ranging from benchmarking and assessments of governance practice to board advisory on engagement with investors. “At Morrow Sodali we recognise that today many of our clients face growing needs for an in-depth and meaningful dialogue with their investors on a broadening range of topics. Having David onboard - from one of the world’s largest fiduciary asset managers - demonstrates our reinforced commitment to helping

MagicStay Expands Its Signature Series with onefinestay19.2.2018 09:09Pressemelding

MagicStay.com , the apartment rental platform for business travelers, is expanding its upscale offering by distributing onefinestay apartments. MagicStay's Signature® range features a selection of upscale and design apartments, managed by professional agencies that pay particular attention to the quality of hospitality and services offered. onefinestay, the world’s leading luxury private rental brand, is positioned in the 4 and 5 star range that can appeal to a business clientele. onefinestay is renowned in the hospitality industry for its high-touch service, which is always curated to each guest and stay. The company, which joined the AccorHotels group in 2016 offers a peace of mind promise which meets MagicStay’s quality and safety criteria. More than 1,000 homes from onefinestay's portfolio in popular business destinations such as London, Paris, New York or Los Angeles complete the MagicStay Signature® range, offering distinctive and authentic accommodation in city centres. Business

GSMA Announces Winners of Inaugural Mobile World Scholar Challenge19.2.2018 09:00Pressemelding

The GSMA today announced the winners of its inaugural Mobile World Scholar Challenge. New for Mobile World Congress 2018, the Mobile World Scholar Challenge is a video-based competition designed to discover and highlight ground-breaking new technologies developed at universities around the globe. This press release features multimedia. View the full release here: http://www.businesswire.com/news/home/20180219005023/en/ GSMA Submitted Photo “Embracing new ideas is the key to innovation and growth, be it an economy, an industry, a company, charity or individual,” said John Hoffman, CEO, GSMA Ltd. “At Mobile World Congress, we are constantly looking to showcase cutting-edge ideas poised to impact the mobile world, and the winners of this first Mobile World Scholar Challenge certainly represent this. Our congratulations to all of the winners, as well as everyone who submitted their innovations for consideration.” Challenge participants submitted short-form videos that promote the science b

Reply 2018 Code Challenge: Join Us19.2.2018 09:00Pressemelding

On 15th March 2018 Reply will launch the first Reply Code Challenge, focused on team programming and open to students and professional coders. All the participant teams who have registered on challenges.reply.com will face the challenge of solving a logical math problem through coding. The idea for code challenges came from the “Reply Code Master Team”, a group of Reply developers passionate about coding competitions and design. After a first internal round involving Replyers, Reply is now opening the challenge up to the world. It’s all about learning together and the fun of competition. Reply believes and invests in talent scouting and lifelong learning. The Reply Code Challenge initiative is part of Reply’s ongoing efforts to promote coding to young people (i.e.: The Code for Kids program that involved more than 15,000 girls and boys among 6-18 years in Europe in the last 24 months) to businesses and geeks. Sign up on challenges.reply.com from 15th February, create a team, and connec

New Data Demonstrates Long-Term Skin Clearance in Patients with Moderate to Severe Plaque Psoriasis Treated with Janssen’s TREMFYA® (guselkumab)19.2.2018 08:00Pressemelding

The Janssen Pharmaceutical Companies of Johnson & Johnson announced today new data that showed a vast majority of patients with moderate to severe plaque psoriasis receiving TREMFYA® (guselkumab), who achieved at least a 90 percent improvement in the Psoriasis Area and Severity Index (PASI 90) at week 28, maintained a PASI 90 response with continuous treatment through week 72.1 Findings from the study also demonstrated that a vast majority of patients originally randomised to guselkumab, but withdrawn from treatment at week 28, regained a PASI 90 response within six months of initiating guselkumab retreatment.1 These long-term findings from the Phase III VOYAGE 2 study were presented at the 2018 American Academy of Dermatology (AAD) Annual Meeting in San Diego, California, during a late-breaking abstract session at 1:00 PM PST (22:00 CET) on Saturday 17 February. “The longer-term data from VOYAGE 2 shows promising results for guselkumab as both a continuous, long-term treatment for mod