Terumo Aortic Receives Prestigious King’s Award for Innovation
Terumo Aortic is honoured to receive the highly prestigious King’s Award for Enterprise in the Innovation category. This very special award is in recognition of the company’s innovative bespoke solutions for complex aortic disease using a combination of surgical and endovascular technologies (subject to local regulatory approval). The award particularly recognises the innovation behind the […]
Terumo Aortic announces US FDA Breakthrough Device Designation for Fenestrated TREO®
Terumo Aortic today announced that the US Food and Drug Administration (FDA) has granted Breakthrough Device Designation for the Fenestrated TREO® Abdominal Stent- Graft system. The FDA’s Breakthrough Device Designation program is intended to fast-track the regulatory review process for certain medical technologies and device-led combination products that satisfy certain criteria; specifically, these include providing […]
Terumo Aortic announces launch of the Rapidlink™ pivotal IDE study in the United States and Europe
Terumo Aortic today announced enrolment of the first patient in the RapidLink™ pivotal Investigational Device Exemption (IDE) study in the US and Europe*. The study is designed to evaluate the safety and effectiveness of the RapidLink™ device for the repair or replacement of supra-aortic vessels during open surgical repair of aortic disease involving the thoracic […]
Terumo Aortic announces launch of the Fenestrated TREO® pivotal IDE study in the United States
The study is designed to evaluate the endovascular repair of juxtarenal and suprarenal aortic aneurysms using the Fenestrated TREO® Abdominal Stent-Graft System. Getinge’s iCast® covered stent system will be used as a bridging stent in this clinical study*. Achieving the first enrolment in this FDA approved IDE is a major milestone that brings us one […]
Terumo Aortic announces FDA approval of dissection and transection indication expansion for the Relay®Pro Stent-Graft system in the United States
Relay®Pro delivers uncompromised clinical performance in the lowest commercially available profile and is indicated for all pathologies of the descending thoracic artery; aneurysm, penetrating atherosclerotic ulcers, transection and dissection. Relay®Pro offers unparalleled accuracy, proven efficacy and durability as well as the widest range of sizes, tapering and configurations on the market, designed to expand the […]
Terumo Aortic announces first implant of innovative custom-made thoracoabdominal hybrid device in North America
This thoracoabdominal repair procedure using Thoracoflo™ was carried out by Dr Randy Moore, Co-Director of the Calgary Complex Aortic Program at the University of Calgary in Canada. Dr Moore and the team at University of Calgary were supported by Professor Sabine Wipper, Chair of Vascular Surgery, University Hospital Innsbruck, Austria, who continues to be a […]
Terumo Aortic announces new technology add-on payment for Thoraflex Hybrid device in the United States
Thoraflex Hybrid is the first of its kind device used in Frozen Elephant Trunk (FET) repair in the United States. It was granted Breakthrough Device Designation by the Food and Drug Administration (FDA) in 2020 followed by FDA approval for commercial sale in the United States earlier this year. This innovative hybrid device allows patients […]
Terumo Aortic announces first commercial implant of the Thoraflex Hybrid device in the USA
Thoraflex Hybrid is a single use medical device combining a Gelweave polyester graft with a Nitinol self-expanding stent graft. It is indicated for the open surgical repair or replacement of damaged or diseased vessels of the aortic arch and repair of the descending thoracic aorta with or without involvement of the ascending aorta, in cases […]
Terumo Aortic announces enrolment of patients in an all-comers TREO AAA study
The TREO Abdominal Stent-Graft System is approved by the US Food and Drug Administration (FDA) to treat patients with abdominal aortic aneurysms. This is a prospective, multi-center, non-randomised, single-arm, post-market study; the purpose is to evaluate the real world, long-term performance of the device as a treatment for patients with infrarenal abdominal aortic aneurysms or […]
Terumo Aortic announces US FDA approval for Thoraflex Hybrid
Thoraflex Hybrid is the first of its kind device used in Frozen Elephant Trunk (FET) repair in the United States and was granted Breakthrough Device Designation by the FDA in 2020. Thoraflex Hybrid is a single use medical device combining a Gelweave polyester graft with a Nitinol self-expanding stent graft and is indicated for the […]
