First Patients in Europe Treated Following CE Approval for GORE® VIABAHN® VBX Balloon Expandable Endoprosthesis

FLAGSTAFF, Ariz. - December 22, 2017 — W. L. Gore & Associates, Inc. (Gore) has announced that the first implants occurred in Europe to restore blood flow to peripheral arteries using the GORE® VIABAHN® VBX Balloon Expandable Endoprosthesis (VBX Stent Graft). The new device is designed for use in the treatment of iliac occlusive disease and also during endovascular aneurysmal repair. The first patients were treated at St. Franziskus Hospital in Münster, Germany.

“We are continuing to elevate and enhance our cardiovascular care offerings with this new technology that more reliably treats peripheral arteries in a minimally invasive way,” said Giovanni Torsello, MD, Professor and Chief of the Department of Vascular Surgery, St. Franziskus Hospital. “The VBX Stent Graft demonstrates a notable, unique combination of technical features beneficial in a broad range of vessels with complex anatomy. Flexibility and accuracy are clearly noticeable. In addition, the VBX Stent Graft provides precise delivery that we can rely on.”

Procedural Summary

The physicians at St. Franziskus Hospital are among a select group of leaders in their field who have been first in Europe to provide the VBX Stent Graft to patients. The VBX Stent Graft recently received CE mark approval and is indicated for endovascular grafting of peripheral vessels.

The patients who received the VBX Stent Grafts presented with iliac occlusive disease and also complex aortic aneurysms treated with branched aortic endograft (BEVAR).

Availability

The VBX Stent Graft was developed utilizing the small diameter, ePTFE stent graft technology from the GORE® VIABAHN® Endoprosthesis. The VBX Stent Graft is configured in a range of diameters from 5 to 11 millimeters and lengths of 15, 19, 29, 39, 59, and 79 millimeters to cover a wide variety of treatment needs. The VBX Stent Graft does not require pre-dilation, which reduces the number of balloons required, and the longer lengths reduce the need to use multiple stents for extensive lesions, both of which also contribute to procedural cost savings.

“The VBX Stent Graft combines an implant with radial strength and conformability to the anatomy along with a trackable delivery system that results in successful outcomes for patients, providers, and physicians,” said Eric Zacharias, Vascular Business Leader. “We look forward to introducing the VBX Stent Graft throughout Europe during 2018.”

Gore provides a portfolio of peripheral vascular solutions that are designed and tested for physicians to more reliably treat patients with a wide range of challenging peripheral disease presentations and improve those patients’ outcomes.* Each interventional solution is engineered for durability, accuracy, thromboresistance, and conformability, and is backed by dedicated service to help improve patient outcomes.

* For complete indications and other important safety information for Gore commercial products referenced herein, refer to the applicable Instructions for Use (IFU).

 

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.

About Gore

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 10,500 Associates and a strong, team-oriented culture, Gore generates annual revenues of $3.7 billion. www.gore.com

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