GORE® TAG® Conformable Thoracic Stent Graft with ACTIVE CONTROL Receives FDA Approval

Image of the GORE® TAG® Conformable Thoracic Stent Graft
Conformable GORE® TAG® Thoracic-Branch Endoprosthesis with Control Modified Deployment System; also Active ; ACMDS; CTAG; AOR; Aortic; Thoracic; Endovascular treatment of thoracic aneurysms, transections and all Type B dissections; ©2017 W. L. Gore & Associates

Today Gore announced that the U.S. Food and Drug Administration (FDA) has granted regulatory approval for commercial distribution for the GORE® TAG® Conformable Thoracic Stent Graft with ACTIVE CONTROL System, a unique Thoracic Endovascular Aortic Repair (TEVAR) solution combining new levels of control with the proven legacy and trusted performance of the Conformable GORE® TAG® Device. The device and delivery system provide new precision and predictable patient outcomes in the endovascular repair of aneurysms, transections, and Type B dissections of the descending thoracic aorta. A smaller-diameter primary delivery sleeve gives the device and system a lower profile across 10 device sizes.

The GORE® ACTIVE CONTROL System provides controlled, two-stage deployment, with primary deployment to an intermediate diameter and a secondary deployment to full diameter. This design allows for continuous blood flow throughout the deployment with multiple opportunities to visualize and refine graft placement. It is also designed to allow for angulation of the proximal end of the device for improved seal and apposition. It gives physicians added precision in placement and angulation so they can take full advantage of the exceptional conformability of the Gore device and confidently provide a minimally-invasive solution to more patients.

No change was made to the GORE® TAG® Conformable Thoracic Stent Graft itself, which, as the world’s most-studied* TEVAR device, has demonstrated long-term freedom from device-related reintervention (93.1%) and low complication rates (zero migrations, fractures, or compressions).** Large device oversizing windows were engineered, tested, and proven to accommodate differences in proximal and distal landing zone diameters; a unique 6% to 33% oversizing window allows physicians to choose the optimal radial force to fit patient anatomy and etiology, whether treating a young trauma patient or a fragile dissected aorta. The 16mm to 42mm range can be treated with as few as five sizes, allowing providers to stock fewer devices while treating a broader range of patients.

“The GORE® TAG® Device family has a legacy of trusted performance and durability, and we knew we could build on that by enhancing control during deployment, which would help make TEVAR procedures more predictable for physicians,” said Eric Zacharias, a vascular business leader at Gore. “Physicians can now deploy our thoracic stent graft in the descending thoracic aorta with more operative ease, even in those patients with challenging angulated aortic arches, and meet the clinical and practical challenges of TEVAR with confidence. With this latest product iteration, Gore is continuing its unparalleled commitment to developing solutions that advance endovascular solutions for diseases of the aorta.”

The GORE TAG Conformable Thoracic Stent Graft with ACTIVE CONTROL System 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 portfolio of products includes the GORE® EXCLUDER® AAA Endoprosthesis for the treatment of abdominal aortic aneurysms (AAA). The GORE® EXCLUDER® Iliac Branch Endoprosthesis is the first FDA-approved, off-the-shelf device for the endovascular treatment of common iliac artery aneurysms or aortoiliac aneurysms, and is intended for use with the GORE EXCLUDER AAA Endoprosthesis.†

* Based on company-sponsored trials and registries shown on clinicaltrials.gov for currently available stent grafts.

** Consolidated site reported outcomes following 5 years of follow-up in TAG 08-01, TAG 08-02, TAG 08-03 clinical studies.

Medical Device News Magazinehttps://infomeddnews.com
Medical Device News Magazine is a division of PTM Healthcare Marketing, Inc.

Santa Casa Hospital System Chooses Carestream for a Unified Diagnostic Workflow

Santa Casa de Misericordia has selected Carestream to replace its legacy diagnostic workflow technology across all seven of its hospitals in Porto Alegre, the capital and largest city of the Brazilian state of Rio Grande do Sul.

American College of Cardiology Thanks Senators McConnell, Kaine for Efforts to Reduce Youth Tobacco...

On behalf of our patients, ACC members thank the Senators for their efforts to reduce youth tobacco use and stand ready to partner with them—and other members of Congress—to enact strong legislation establishing a federal age of 21 for the sale of all tobacco products.”

ResMed Study Finds CPAP Adherence Improved by Remote Monitoring, Self-Monitoring Across 3 Countries

ResMed reports the average adherence to PAP (positive airway pressure), the gold standard for treating sleep apnea, is approximately 50 percent when using legacy technology with no cloud connectivity or remote monitoring capabilities.

Life Image and Bialogics Analytics Partner to Enable Provider Organizations to Optimize Operations, Interoperability

The Life Image and Bialogics partnership will streamline access to analytics of medical imaging in order to help provider organizations enhance operational and financial performance, and improve patient satisfaction.

MediSpin XL™ – Cutting-Edge High-Volume Electrospinning Production Platform for Medical Devices is Launched

The launch of the MediSpin XL™ platform marks a global breakthrough in the controlled large-scale production of well-defined scaffolds for implants and membranes using fibers ranging from nanometer up to micrometer scale.

Hemodialysis Vascular Grafts Market Size Worth $276.5 Million By 2025

Increasing number of patients suffering from chronic kidney diseases (CKD) and growing adoption of biological access products due to technological advancements in the field are some of the factors contributing to revenue growth. Higher number of renal impaired patients and limited availability of suitable kidney donors are promoting hemodialysis procedures in renal impaired patients, which in turn is expected to fuel the demand for vascular grafts over the forecast period.