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

Pierre Fabre & Array BioPharma Announce a 62% Observed OS at One Year from the Phase 3 BEACON CRC Safety Lead-In of the Combination of Encorafenib, Binimetinib and Cetuximab in BRAF-Mutant CRC at the ESMO GI Congress23.6.2018 11:00Pressemelding

Not intended for UK- and US-based media Pierre Fabre and its partner Array BioPharma Inc. today announced updated safety and efficacy results, including OS, from the safety lead-in of the Phase 3 BEACON CRC trial evaluating the triplet combination of encorafenib, a BRAF inhibitor, binimetinib, a MEK inhibitor and cetuximab, an anti-EGFR antibody, in patients with BRAF V600E -mutant metastatic colorectal cancer (CRC). The results showed that, at the time of analysis, the OS data were fully mature through 12.6 months and that the median OS had not yet been reached. The one-year overall survival rate for this cohort was 62%. These data were presented in an oral presentation on Saturday, June 23, at the ESMO 20th World Congress on Gastrointestinal Cancer in Barcelona, Spain. The median progression-free survival (mPFS) for patients treated with the triplet was 8 months [95% CI 5.6-9.3] and is similar between patients receiving one prior line of therapy and patients receiving two prior lines

Compelling Data for LONSURF® (trifluridine/tipiracil) in Metastatic Colorectal Cancer Presented at ESMO’s World Congress on Gastrointestinal Cancer by Servier and Taiho23.6.2018 08:10Pressemelding

Servier and Taiho Pharmaceutical Co., Ltd. today announced that the TASCO-1 trial demonstrated promising results for LONSURF® (trifluridine/tipiracil) in combination with bevacizumab in patients with previously untreated metastatic colorectal cancer (mCRC) who are not suitable for intensive treatment, with a median progression-free survival (PFS) of 9.2 months (ranging from 7.6 to 11.5 months). A second non-comparative arm in the trial, evaluated the outcome of patients treated with the current standard of care of capecitabine in combination with bevacizumab. The median PFS of this arm was 7.8 months (ranging from 5.5 to 10.1 months). “Colorectal cancer is the third most common cancer in the world. While there has been some progress in treatment, there are still few options for patients with metastatic disease who are not suitable for intensive treatment,” said Professor Eric Van Cutsem, Head of Digestive Oncology at the University of Leuven, Belgium. “These compelling results suggest

Softomotive and Accelerate RPA Partner to Help Enterprises Achieve Faster Time to Value from RPA22.6.2018 15:13Pressemelding

Softomotive, a world–class Robotic Process Automation (RPA) technology provider offering best time to value and affordability for all sizes and types of enterprises, is pleased to announce a strategic partnership with AccelerateRPA, a high calibre professional services provider of trained and certified RPA Consultants within Robotic Process Automation. This partnership means that customers and end users of Softomotive’s software, will have additional knowledgeable and professional guidance available to help achieve significant value quickly from their investment in RPA. Companies who are looking to implement Softomotive’s RPA product suite (WinAutomation and ProcessRobot software) will now have direct access to AccelerateRPA’s highly skilled consultants and Developers. Further, AccelerateRPA has also become a licensed reseller of Softomotive’s products, offering customers a single point of contact for delivering both RPA software and services. Ashley Hudson, Director of AccelerateRPA,

Ascend Performance Materials Announces Price Increase for Intermediate Materials22.6.2018 14:00Pressemelding

Ascend Performance Materials announced today a price increase for its intermediate materials. The price increase will take effect globally on July 1, 2018, and includes the following terms: Material Price Increase Terms Hexamethylene diamine (HMD) $0.17/lb. • As contracts allow. • Non-contract business – price determined on an order-by-order basis. Acrylonitrile (AN) $0.20/lb. • As contracts allow. • Non-contract business – price determined on an order-by-order basis. Customers should contact their local sales representative for additional information. About Ascend Performance Materials Ascend Performance Materials is a global premium provider of high-quality plastics, fibers and chemicals and is the world’s largest integrated producer of PA66 resin. Headquartered in Houston, Texas, Ascend has eight global locations, including five fully-integrated manufacturing facilities located in the southeastern United States, all dedicated to the innovation and safe production of nylon 6,6. With

Different Countries, Different Customs: Get Ready for the Motorbike Holidays with Moto-tyres.co.uk22.6.2018 13:41Pressemelding

Pack your bags, close the boot and get away on holiday? When you start your holidays on a motorcycle, you usually have to consider a few things more when getting ready for your trip. The right preparation is therefore a must. So that nothing stands in the way of a smooth journey, Moto-tyres.co.uk has put together some tips for your next trip. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20180622005345/en/ Different countries, different customs: get ready for the motorbike holidays with Moto-tyres.co.uk (Photo: Business Wire) Whether a weekend trip or extended adventure, it all depends on the right equipment. Functional clothing, protectors and rain protection are a must on long trips. Wearing a suitable motorcycle helmet is a legal requirement almost everywhere. However, there are also very different rules and regulations for motorbike equipment and accessories depending on the destination, and you should familiarise yoursel

Boehringer Ingelheim bolsters biologics research and development with 230 million euro investment in new development center22.6.2018 12:00Pressemelding

Today Boehringer Ingelheim announced a 230 million euro investment into a new Biologicals Development Center (BDC) at the company’s Research and Development site in Biberach, Germany during the foundation stone laying for the new center. “The BDC is another key building block supporting the company’s long-term strategy for increasing the pipeline’s share of biologicals. This is particularly driven by two of our core areas, immune oncology and immunology,” says Dr. Fridtjof Traulsen, Corporate Senior Vice President Development at Boehringer Ingelheim. “The share of new biological entities in Boehringer Ingelheim’s research pipeline has been consistently increasing over the past few years and has now reached forty percent.” The BDC will help to maximize synergies by integrating biologicals analytical and process development as well as manufacturing for clinical studies into one seamless unit, while at the same time increasing development capacity. Following a staggered launch beginning i