FDA News

FDA grants approval for thoracic stent graft for TEVAR procedures

W.L. Gore and Associates announced it has received FDA approval for a thoracic stent graft with a new delivery system used for thoracic endovascular aortic repair procedures.

The stent graft and delivery system (TAG Conformable Thoracic Stent Graft with Active Control System) provides an advanced level of precision and predictable patient outcomes in the endovascular repair of aneurysms, transections and type B dissections of the descending thoracic aorta, the company stated in a press release.

According to the release, the design of the delivery system allows for continuous blood flow throughout the deployment and gives operators multiple opportunities to visualize and refine graft placement.

“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,” Eric Zacharias, a vascular business leader at W.L. Gore and Associates, said in the release.

W.L. Gore and Associates announced it has received FDA approval for a thoracic stent graft with a new delivery system used for thoracic endovascular aortic repair procedures.
Source: W.L. Gore and Associates. Reprinted with permission.

No changes were made to the stent graft, which demonstrated long-term freedom from device-related reintervention of 93.1% and low complication rates in clinical studies, the company stated in the release.

Disclosures: Zacharias is an employee of W.L Gore and Associates.

W.L. Gore and Associates announced it has received FDA approval for a thoracic stent graft with a new delivery system used for thoracic endovascular aortic repair procedures.

The stent graft and delivery system (TAG Conformable Thoracic Stent Graft with Active Control System) provides an advanced level of precision and predictable patient outcomes in the endovascular repair of aneurysms, transections and type B dissections of the descending thoracic aorta, the company stated in a press release.

According to the release, the design of the delivery system allows for continuous blood flow throughout the deployment and gives operators multiple opportunities to visualize and refine graft placement.

“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,” Eric Zacharias, a vascular business leader at W.L. Gore and Associates, said in the release.

W.L. Gore and Associates announced it has received FDA approval for a thoracic stent graft with a new delivery system used for thoracic endovascular aortic repair procedures.
Source: W.L. Gore and Associates. Reprinted with permission.

No changes were made to the stent graft, which demonstrated long-term freedom from device-related reintervention of 93.1% and low complication rates in clinical studies, the company stated in the release.

Disclosures: Zacharias is an employee of W.L Gore and Associates.