News | February 10, 2009

Gore Receives FDA Clearance for Modification to TAG Thoracic Endoprosthesis


February 10, 2009 - W. L. Gore and Associates today said at the annual International Congress of Endovascular Interventions XXII, it received FDA approval to market a modified version of the GORE TAG Thoracic Endoprosthesis for the treatment of thoracic aortic aneurysms (TAAs).

The improved delivery catheter enhances the previous version of the GORE TAG Thoracic Endoprosthesis by adding a soft flexible tip to the leading end of the delivery system. The soft tip improves flexibility at the wire/catheter interface to facilitate tracking through challenging aortic anatomy, the company said. The hub component has also been modified to improve ease of use and durability.

The GORE TAG Thoracic Endoprosthesis is an option for less invasive treatment of TAA, an aneurysm of the descending thoracic aorta. TAA is a life-threatening condition generally believed to be significantly under-diagnosed, and patients with TAA are at risk of death due to internal bleeding resulting from a ruptured aorta. The GORE TAG Thoracic Endoprosthesis is also the only thoracic device with more than 10 years of worldwide clinical data. It was first approved by the FDA in March 2005 and has been granted regulatory approval in Europe, Japan and South Korea. Gore has already begun distribution of the upgraded delivery system, and plans to have this completed across the U.S. within the next few months.

The GORE TAG Thoracic Endoprosthesis is comprised of an ePTFE graft with an outer self-expanding nitinol support structure to combine both device flexibility and material durability. The device is inserted by a catheter delivery technique through a small incision in the patient’s groin.

For more information: www.goremedical.com


Related Content

News | Cardiovascular Surgery

Oct. 23, 2024 – The Society for Vascular Surgery (SVS) is launching a three-year patient education campaign, Highway to ...

Home October 23, 2024
Home
News | Cardiovascular Surgery

June 13, 2024 — Medtronic plc, a global leader in healthcare technology, today announced the launch of its latest ...

Home June 13, 2024
Home
News | Cardiovascular Surgery

June 3, 2024 — Morristown Medical Center’s Gagnon Cardiovascular Institute’s structural heart program recently reported ...

Home June 03, 2024
Home
News | Cardiovascular Surgery

May 16, 2024 — A recent publication in the American Heart Association Circulation highlights a comprehensive ...

Home May 16, 2024
Home
News | Cardiovascular Surgery

April 30, 2024 — The expanding use of transcatheter technologies has changed the landscape in the treatment of valvular ...

Home April 30, 2024
Home
News | Cardiovascular Surgery

April 23, 2024 — Medtronic plc, a global leader in healthcare technology, today announced the launch of its latest ...

Home April 23, 2024
Home
News | Cardiovascular Surgery

March 20, 2024 — PECA Labs, a medical device company reimagining the field of vascular grafts and valves with durable ...

Home March 20, 2024
Home
News | Cardiovascular Surgery

February 26, 2024 — Hackensack Meridian Jersey Shore University Medical Center and Hackensack University Medical Center ...

Home February 26, 2024
Home
Feature | Cardiovascular Surgery

The DAIC team has learned of the passing of Alain Cribier, MD, FACC, heralded as the man who pioneered the first ...

Home February 23, 2024
Home
News | Cardiovascular Surgery

January 29, 2024 — Despite national guidelines recommending surgical aortic valve replacement (SAVR) for patients under ...

Home January 29, 2024
Home
Subscribe Now