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Terumo Aortic announces launch of Fenestrated Treo pivotal IDE study in US
Terumo Aortic today announced enrollment of the first patient in the Fenestrated Treo pivotal investigational device exemption (IDE) study in the U.S. This study is designed to evaluate the endovascular repair of juxtarenal and suprarenal aortic aneurysms using the Fenestrated…
Terumo Aortic and Bentley announce collaboration on US FEVAR study
Terumo Aortic and Bentley today announced their partnership in a clinical study in the USA. The objective is to obtain US Food and Drug Administration (FDA) investigational device exemption (IDE) approval for Terumo Aortic’s fenestrated Treo device, in combination with…
Terumo Aortic announces ‘significant policy milestone’ with CMS establishing new DRG 209 for complex aortic arch procedures
Terumo Aortic today announced what it describes as a “significant policy milestone” with the Centers for Medicare & Medicaid Services (CMS) establishing a new Medicare Severity Diagnosis-Related Group (MS-DRG), MS-DRG 209, for complex aortic arch procedures. A company press release…
FDA approves dissection and transection indication expansion for RelayPro stent graft system
Terumo Aortic announced that the Food and Drug Administration (FDA) has granted approval of the RelayPro thoracic stent graft device for the treatment of dissection and transection in the U.S. A Terumo Aortic press release notes that RelayPro delivers uncompromised…
First implant of custom-made thoracoabdominal hybrid device in North America announced
Terumo Aortic announced the first North American implant of a custom-made hybrid device, Thoracoflo. A press release noted that the device is used to treat patients with thoracoabdominal aortic disease using a less invasive surgical technique than traditional open surgical…
Terumo Aortic announces new technology add-on payment for Thoraflex Hybrid device in US
The Centers for Medicare and Medicaid Services (CMS) has granted approval of a new technology add-on payment (NTAP) for Terumo Aortic’s Thoraflex Hybrid device—used to treat aortic arch disease—under the inpatient prospective payment system (IPPS). The add-on payment is effective…
Terumo Aortic announces first commercial implant of Thoraflex Hybrid in US
Following the recent approval by the Food and Drug Administration (FDA) of the Thoraflex Hybrid frozen elephant trunk (FET) device for the treatment of patients with complex aortic arch disease, Terumo Aortic has now announced the first commercial implant of…
Terumo Aortic announces first commercial implants of RelayPro in US
Terumo Aortic today announced the first commercial implants in the U.S. of its RelayPro thoracic stent-graft system. This follows the recent approval by the Food and Drug Administration (FDA) of a device designed to treat patients with fusiform and saccular…
RelayPro thoracic stent graft approved by FDA
Terumo Aortic today (Friday, Aug. 6) announced that the Food and Drug Administration (FDA) has granted approval of the RelayPro thoracic stent-graft system for sale in the United States for the treatment of patients with thoracic aortic aneurysms (TAAs) and…
RelayPlus thoracic stent graft post-approval study reports low operative mortality
Terumo Aortic has announced the midterm results from the RelayPlus thoracic stent graft system post-approval study, revealing low operative mortality and morbidity— supporting its use as a “safe and effective” thoracic aortic aneurysm treatment. Over a three-year period, the RelayPlus…