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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…
Aquedeon Medical receives FDA approval to expand clinical trial of Duett vascular graft system
The Food and Drug Administration (FDA) has approved the expansion of Aquedeon Medical’s investigational device exemption (IDE) clinical trial evaluating the Duett vascular graft system, a company press release reveals. Duett is a novel device designed to facilitate open surgical repair…
Endospan announces positive 30-day outcomes from TRIOMPHE IDE study
Endospan recently announced the presentation of 30-day results from the statistical dissection primary arm of the TRIOMPHE investigational device exemption (IDE) clinical study. The data were presented during the late-breaking trial session at the American Association for Thoracic Surgery (AATS)…
The endovascular revolution and open aortic training: ‘It’s not necessarily a crisis but it could become one’
Jean Panneton, MD, considers himself what he terms a “blue-collar” vascular surgeon as much as one engaged in academic practice and the necessity of helping contribute to the next generation of vascular surgeons. He operates. And he operates a lot.…
Artivion granted FDA humanitarian device exemption for the AMDS hybrid prosthesis
Artivion recently announced that the Food and Drug Administration (FDA) has granted a humanitarian device exemption (HDE) for use of the AMDS hybrid prosthesis (formerly known as the Ascyrus Medical dissection stent) in acute DeBakey type I dissections in the…
Hybrid aortic arch: ‘We believe there is still a role for a versatile multiple-branched arch option’
Mid-term results from an analysis of a series of hybrid aortic arch reconstructions utilizing overlapping single thoracic branch endoprostheses in a dual-branch configuration showed the technique to be safe and versatile. Delivered at the 2024 Western Vascular Society (WVS) annual…
Endospan completes enrolment of primary arm in TRIOMPHE IDE clinical study
Endospan today announced the completion of enrolment for the primary arm of its TRIOMPHE investigational device exemption (IDE) clinical study investigating the Nexus aortic arch stent graft. The study is evaluating the safety and efficacy of the device for the…
Cook Medical creates custom-made aortic device for fenestrated FET procedure
Cook Medical this week announced that it has created a custom-made device for the frozen elephant trunk (FET) aortic procedure. A press release details that, earlier this year, cardiothoracic surgeon François Dagenais, MD, from the Quebec Heart and Lung Institute…
First patient enrolled in IDE study of Aquedeon Medical’s Duett vascular graft system
Aquedeon Medical has announced the initiation of an investigational device exemption (IDE) clinical trial to study the Duett vascular graft system. A press release reveals that, this February, the first enrolled patient underwent open surgical aortic arch reconstruction at the…
Endospan releases early TRIOMPHE IDE study results at Society of Thoracic Surgeons annual meeting
Endospan shared 30-day results from the first 22 patients enrolled in the TRIOMPHE investigational device exemption (IDE) study in a late-breaking presentation at the 60th annual meeting of the Society of Thoracic Surgeons (27–29 January, San Antonio, USA). TRIOMPHE is…