W.L. Gore & Associates said today its Tag conformable thoracic stent graft was used in its 1st commercial procedure after the system won CE Mark approval in the European Union last month.
The procedure was performed by Dr. Giovanni Torsello and Dr. Martin Austermann of Munster, Germany’s St. Franziskus Hospital, the Flagstaff, Ariz.-based company said.
“The enhanced control capabilities this new delivery system allows could reduce many common complications that can occur if the stent graft is not placed correctly during the TEVAR procedure. Secondary interventions can be traumatic for patients and costly to the provider. The innovative staged deployment feature of the Gore Active Control System provides a level of precision that has never existed in TEVAR. This level of control in combination with the long-term benefits of the stent graft is a significant advancement for the field,” Dr. Giovanni Torsello of Munster, Germany’s St. Franziskus Hospital said in a prepared statement.
Gore’s thoracic endovascular aortic repair device is designed with a new delivery system to allow for controlled, staged deployment. The system is designed to improve accuracy, angulation and apposition for treating etiologies of the descending thoracic aorta including aneurysms, transections and acute and chronic Type B resections, the company said.
“Since Gore pioneered the first TEVAR device in Europe two decades ago, we have welcomed feedback from our physician partners to innovate and evolve our stent graft offerings for better long-term patient care. 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. Physicians can now deploy our thoracic stent graft in the descending thoracic aorta with more operative ease, even in those patients with extremely 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,” Gore vascular biz leader Eric Zacharias said in a press release.
The company has a planned formal rollout of the devices in European regions later this year.
Last month, Gore said it won FDA 510(k) clearance for its Synecor preperitoneal biomaterial hernia repair device.
The Synecor preperitoneal biomaterial is a hybrid biosynthetic hernia repair device designed for use in single-stage preperitoneal, onlay and retromuscular placements through open, laparoscopic and robotic procedures.
