First-in-Human (FIH) trial for the new generation Resorbable Magnesium Scaffold (RMS)
PUTZBRUNN, GERMANY (October 27, 2022) — W. L. Gore & Associates, Inc. (Gore) announced the completion of target enrollment in the EXPAND Post-Market Registry of the GORE® VIABAHN® VBX Balloon Expandable Endoprosthesis (VBX Stent Graft)*. 280 patients at 15 European sites have been enrolled to collect safety and performance data of the VBX Stent Graft to evaluate how the device performs in real-world cases and to continue their commitment to advancing patient care in the treatment of various diseases.
The EXPAND registry
This prospective, multicenter registry offers an opportunity to understand the varied usages for the VBX Stent Graft to treat different pathologies in a wide range of anatomical locations. These include lesion exclusion (non-iatrogenic, such as aneurysmatic disease, or iatrogenic, inclusive of ruptures or perforation), visceral perfusion (including fenestrated/branched bridging stent), luminal reconstruction (arteriovenous fistulas) or occlusive disease with the exception of de novo iliac occlusive disease. De novo iliac occlusive disease was already captured in the Gore VBX FLEX Clinical Study, which reported robust procedural success and durable clinical outcomes through three years, with 96.9% primary patency at nine months and 91.2% freedom from target lesion revascularization (TLR) at three years.
“Currently we do not have real-world data to evaluate the variety of covered balloon expandable devices in the different anatomies. Using EXPAND to understand the safety and performance of the VBX Stent Graft in these anatomical locations, alongside the VBX FLEX trial, is key to determining future treatment options for our vascular patients with this device“, said Prof. Mauro Gargiulo, Chair of Metropolitan Unit of Vascular Surgery at IRCCS S. Orsola Hospital in Bologna and Principal Investigator of the Registry.
Patients enrolled in EXPAND registry will be followed for five years, with a primary endpoint evaluating procedural success and freedom from VBX Stent Graft-related serious adverse event at 30 days, and secondary endpoints on safety and efficacy through five years.
“The EXPAND registry will help us advance our patient care and improve our clinical outcomes based on the long-term real-world evidence it will provide”, commented Dr. Martin Austermann, Director of the Clinic for Vascular Surgery at St. Franziskus Hospital in Münster, the site that has enrolled the most number of patients. “Of considerable appeal is evaluating the use of the VBX Stent Graft as a bridging stent for complex aortic fenestrated and branched endovascular repair. Gore is the first company with a real-world registry capturing these categories and whose one year follow-up has recently been presented at Charing Cross and LINC congresses.” continued Dr. Austermann.
GORE® VIABAHN® VBX Balloon Expandable Endoprosthesis offers precise delivery and supports positive outcomes in complex aortoiliac applications. The device was developed utilizing the small diameter, ePTFE stent graft technology from the GORE® VIABAHN® Endoprosthesis. The VBX Stent Graft is available in a range of diameters from 5 to 11 mm and lengths of 15, 19, 29, 39, 59 and 79 mm to cover a wide variety of treatment needs.
EXPAND is part of Gore’s dedication to post-market surveillance and monitoring long-term device performance in an effort to improve clinical practice and patient outcomes. Data will be representative of real-world, clinical use. Real-world clinical use data are integral for Gore, combined with data from long-term clinical investigations and reports from medical literature, to perform continuing assessments of device performance in addition to any long-term clinical investigations as well as reports in medical journals and congress presentations.
“EXPAND provides an invaluable resource not only for Gore, but also for our physicians,” said Jenny Hoffmann, Gore Peripheral Business Leader. “We are committed to collecting real-world data on our devices, and through sharing it with the wider physician community, it allows us to truly realise our vision of Together, improving life.”
For more information about the GORE® VIABAHN® VBX Balloon Expandable Endoprosthesis, visit https://www.goremedical.com/eu/products/vbx
Gore engineers medical devices that treat a range of cardiovascular and other health conditions. With more than 50 million medical devices implanted over the course of more than 45 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.
W. L. Gore & Associates is a global materials science company dedicated to transforming industries and improving lives. Since 1958, Gore has solved complex technical challenges in demanding environments — from outer space to the world’s highest peaks to the inner workings of the human body. With more than 11,000 Associates and a strong, team-oriented culture, Gore generates annual revenues of $3.8 billion.
Products listed may not be available in all markets. GORE, Together, improving life, VBX, VBX FLEX, VIABAHN and designs are trademarks of W. L. Gore & Associates. © 2022 W. L. Gore & Associates GmbH