Technology | Stent Grafts | May 15, 2019

Gore Receives FDA Approval for Gore Tag Conformable Thoracic Stent Graft

Device features Gore Active Control System for controlled, two-stage deployment

Gore Receives FDA Approval for Gore Tag Conformable Thoracic Stent Graft

May 15, 2019 — W. L. Gore & Associates Inc. (Gore) announced the U.S. Food and Drug Administration (FDA) has granted regulatory approval for commercial distribution of the Gore Tag Conformable Thoracic Stent Graft with Active Control System. The device is a thoracic endovascular aortic repair (TEVAR) solution combining new levels of control with the 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 conformability of the Gore device and confidently provide a minimally-invasive solution to more patients.

No change was made to the stent graft itself, which has demonstrated long-term freedom from device-related reintervention (93.1 percent) 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 6-33 percent 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 16-42mm range can be treated with as few as five sizes, allowing providers to stock fewer devices while treating a broader range of patients.

For more information: www.gore.com

Related Content

Gallery | Cath Lab | October 31, 2019
This is a photo essay of the interventional cardiology and structural heart technologies on the expo floor and discus
The Alphenix Aero Package from Canon Medical Systems USA, Inc. enables OBLs and ASCs to attain premium technology at a flexible price point by tailoring Canon Medical’s Alphenix systems to fit their facilities’ needs.

The Alphenix Aero Package from Canon Medical Systems USA, Inc. enables OBLs and ASCs to attain premium technology at a flexible price point by tailoring Canon Medical’s Alphenix systems to fit their facilities’ needs.

Technology | Cath Lab | October 28, 2019
Office based labs (OBLs) and ambulatory surgery centers (ASCs) require a fresh perspective from imaging vendors.
Marco Costa, M.D., Ph.D., MBA, president, UH Harrington Heart and Vascular Institute, performing a cath lab procedure.

Marco Costa, M.D., Ph.D., MBA, president, UH Harrington Heart and Vascular Institute, performing a cath lab procedure.

News | Cath Lab | October 28, 2019
October 28, 2019 — Leaders within University Hospitals and the Harrington Heart and Vascular Institute had a vision t
OmniVision Announces Guinness World Record for Smallest Image Sensor

OmniVision's OVM6948 CameraCubeChip, a fully packaged, wafer-level camera module measuring 0.65mm x 0.65mm x 1.158mm, built on OmniVision's OV6948, winner of the Guinness World Record for “The Smallest Image Sensor Commercially Available.”

News | Cath Lab | October 22, 2019
October 22, 2019 — OmniVision Technologies Inc.
People watch the presentation of the five-year EXCEL Trial data by Gregg Stone, M.D., live in the Abbott booth at TCT 2019. Abbott makes the Xience stent used in the trial, which compared equally with long term surgical outcomes. #TCT2019

People watch the live presentation of the five-year EXCEL Trial data by Gregg Stone, M.D., in the Abbott booth at TCT 2019. Abbott makes the Xience stent used in the trial, which compared equally with long-term CABG surgical outcomes. 

Feature | Cath Lab | October 03, 2019
October 3, 2019 – Five-year data from the EXCEL Trial showed patients with left main coronary disease treated with pe
Two Stents Implanted in Democratic Presidential Candidate Bernie Sanders, suffers chest pain
News | Cath Lab | October 02, 2019 | Dave Fornell, Editor
October 2, 2019 — Democratic presidential candidate Sen.
Bypass Surgery and Coronary Stenting Yield Comparable 10-Year Survival
News | Cath Lab | September 25, 2019
Ten-year survival rates are similar for bypass surgery and coronary stenting with drug-eluting stents in randomized...
Complete Revascularization Superior to Culprit Lesion-only Intervention
News | Cath Lab | September 10, 2019
An international randomized trial has shown that complete revascularization reduces major cardiovascular events...
The cath lab staff UH Portage Medical Center.

The cath lab staff UH Portage Medical Center.

Feature | Cath Lab | September 09, 2019 | Anjan Gupta, M.D., FACC, FSCAI
Primary percutaneous coronary intervention (PCI) is the preferred treatment for acute...
Overlay Init