The first patient has been enrolled in Bolton Medical’s RelayPro US Food and Drug Administration (FDA) Phase II clinical trial.
The first US patient has been treated with VentureMed Group’s Flex scoring catheter. The catheter is used to treat patients with end-stage renal disease.
iVascular SLU has announced the initiation of the TINTIN trial, evaluating the combined therapy of Luminor drug-coated balloon (DCB) and iVolution self-expandable stent.
Preliminary 30-day data from the PRELUDE trial investigating the use of the Serranator Alto percutaneous transluminal angioplasty (PTA) serration balloon catheter (Cagent Vascular) have shown 100% technical success and good effectiveness in moderate to severe calcification in the superficial femoral artery. The acute results show that the balloon can achieve low residual stenosis, and final six-month results are expected by the end of 2017.
New ACT 1 subgroup analysis demonstrates that in female patients the rate of ipsilateral stroke is lower with carotid artery stenting (CAS) compared with endarterectomy (CEA), while in highly atherosclerotic patients stenting seems to deliver better overall long-term results than endarterectomy.
Benjamin Starnes, chief of Vascular Surgery at the University of Washington (Seattle, USA), has reported successful results for the first 30 patients undergoing fenestrated endovascular aneurysm repair (FEVAR) planned and performed using Aortica’s AortaFit automated case planning software.
Drug-eluting technologies, such as balloons coated with paclitaxel (DCB), are now the gold standard treatment for patients presenting with symptomatic peripheral artery disease (PAD) in the femoropopliteal region. DCBs have shown better clinical outcomes against uncoated balloons (PTA) for the treatment of femoropopliteal disease in large multicentre trials. After the introduction of the first DCB (Lutonix’s 0.035 over-the-wire DCB) there have been several entrants into the market. However, multiple clinical and pre-clinical studies have illustrated there are differences in performance and safety between the different products.
Over the past few years, we have seen an increased awareness of the role of mental health in several health outcomes, note Marlene Grenon and Greg J Zahner. One may wonder what is happening with our patients who suffer from vascular diseases; are they similarly affected by mental health diseases? While the rising toll of peripheral artery disease (PAD) on our world’s ageing population is no secret to the vascular surgeon, depression has quietly become the second leading cause of years lived with disability.
It is now almost a decade since the first patient underwent catheter-based renal denervation as a participant in a safety and proof-of concept study (SYMPLICITY HTN-1). Since then, SYMPLICITY HTN-3 has indicated that renal denervation does not provide benefit for patients with resistant hypertension and the recently published SPYRAL HTN-OFF MED has shown that it does provide benefit for patients who are not receiving antihypertensive medication. In this commentary, Markus P Schlaich reviews the evidence for renal denervation.
Essential Medical has announced the completion of enrolment in the US pivotal investigational device exemption (IDE) trial of the Manta large bore vascular closure device.
Endologix has received Investigational Device Exemption (IDE) approval from the US Food and Drug Administration (FDA) to commence a confirmatory clinical study (EVAS2) to evaluate the safety and effectiveness of the Nellix endovascular aneurysm sealing system (EVAS) for the treatment of infrarenal abdominal aortic aneurysms.
Essential Medical has announced initiation of enrolment in a post-market clinical registry in the regions where Manta is commercially available.
CryoLife has entered into a definitive agreement to acquire Jotec AG. A press release states that the combination of CryoLife and Jotec will create a company “with a broad and highly competitive product portfolio focused on aortic surgery, and will position CryoLife to compete strongly in the important and growing endovascular surgical markets.”
Medtronic has received US Food and Drug Administration (FDA) approval for the Endurant II/IIs stent graft system to treat abdominal aortic aneurysm (AAA) patients with neck lengths down to 4mm and <=60 degrees infrarenal angulation when used in combination with the Heli-FX EndoAnchor system. The expanded indication enables the Endurant II/IIs stent graft to be used in conjunction with the Heli-FX EndoAnchor system to treat a wider range of patients with short, hostile aortic neck anatomies, independent of renal stenting.
The US Centers for Medicare and Medicaid Services (CMS) has determined that there is now sufficient evidence to cover supervised exercise therapy for the treatment of intermittent claudication. This decision will likely provide a boost to supervised exercise therapy programmes in the USA, with US physicians now enjoying greater flexibility when considering approaches for intermittent claudication. However, supervised exercise therapy is not without its obstacles. Vascular News spoke to an international selection of experts, who noted that poor patient adherence, lack of funding and physician disinterest still represent barriers to widespread adoption of such programmes.
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