Medtronic today announced Shonin approval from the Ministry of Health, Labour and Welfare (MHLW) and the launch of the Valiant Navion thoracic stent graft system in Japan for the minimally invasive repair of thoracic descending aortic aneurysms (TAA) and complicated type B aortic dissections (TBAD). The news marks the third major geographical launch of the Valiant Navion, following US Food and Drug Administration (FDA) and CE mark approvals in late 2018.

The US Food and Drug Administration (FDA) have issued a new safety communication on the risk of Type III endoleaks with use of the Endologix AFX endovascular graft systems for the treatment of abdominal aortic aneurysms (AAA).

The National Institute for Health and Care Excellence (NICE) has published the final appraisal determination (FAD) recommending the use of Xarelto (rivaroxaban) by the National Health Service (NHS) in England at a dose of 2.5mg twice daily combined with aspirin (75–100mg) once daily as an option for preventing atherothrombotic events in adult patients with coronary artery disease (CAD) or symptomatic peripheral artery disease (PAD) who are at high risk of ischaemic events.¹

Cardiothoracic surgeon David Taggart (Department of Cardiac Surgery, University of Oxford, John Radcliffe Hospital, Oxford, UK) told delegates attending the 2019 European Association for Cardio-Thoracic Surgery (EACTS) meeting (3–5 October, Lisbon, Portugal) that the definition of myocardial infarction used in EXCEL was incorrect, leading to the wrong conclusion that percutaneous coronary intervention (PCI) is non-inferior, at five years, to coronary artery bypass grafting (CABG) for the management of selected patients with left main disease. Taggart was an EXCEL trial investigator but withdrew his name as an author because of his view on the conclusion. 

The Gore Cardioform Occluder for atrial septal defects (ASD) has received CE mark in Europe, the company has announced, stating that the move was supported by data from the Gore ASSURED clinical study.

LimFlow has announced that the US Food and Drug Administration (FDA) has approved its investigational device exemption (IDE) for the PROMISE II pivotal study of the LimFlow Percutaneous Deep Vein Arterialisation (pDVA) System.

A strategy of complete revascularisation was superior to culprit lesion-only percutaneous coronary intervention (PCI) in reducing the risk of cardiovascular death or myocardial infarction (MI) in patients with ST-segment myocardial infarction (STEMI) and multivessel coronary artery disease, as well as reducing the risk of a composite of CV death, MI or ischaemia driven revascularisation.

AstraZeneca has announced detailed results from the positive Phase III THEMIS trial, which showed BRILINTA (ticagrelor) plus aspirin reduced the relative risk for the composite of cardiovascular (CV) death, heart attack, or stroke by 10% (7.7% vs. 8.5%) compared with aspirin alone, a statistically significant reduction.

A recent study concludes that the interplay of anatomical and physiological factors in patients with complex aneurysms renders conventional risk stratification tools “unhelpful”, and that a multidisciplinary approach to assessment is mandated. Furthermore, the investigators suggest it is “unusual” that a single major factor ultimately determines treatment modality.