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.
HyperMed Imaging is now selling its new HyperView imaging system to customers in the USA.
The European Commission has approved, under the EU Merger Regulation, the acquisition of Bard by BD. The decision is conditional on the divestment of BD’s core needle biopsy devices business, and tissue marker product that is currently under development.
Endologix has appointed John Onopchenko as the company’s chief operating officer, effective as of 30 October, 2017. Onopchenko will be responsible for managing Endologix’s manufacturing, supply chain, and quality organisations.
Surmodics has announced enrolment of the first patient in TRANSCEND, the pivotal clinical trial for the SurVeil drug-coated balloon (DCB). The randomised trial will evaluate the SurVeil DCB for treatment for peripheral artery disease (PAD) in the upper leg compared to a commercially available DCB treatment.
Symic Bio has announced results from the phase I/II SHIELD trial evaluating SB-030, a locally administered therapeutic, in patients with peripheral vascular disease undergoing angioplasty. In this first-in-human, prospective, randomised, single-blind controlled study of 67 patients, SB-030 demonstrated a positive safety profile, with no clinically meaningful difference observed in adverse events between treatment and control groups. In addition, treatment with SB-030 demonstrated potential for improvements as compared to control across measurements of clinical efficacy in late lumen loss, target lesion revascularisation and primary patency rate.
Avinger has announced initiation of INSIGHT, a prospective, global, single arm, multicentre study to evaluate the safety and effectiveness of the Pantheris Lumivascular Atherectomy System for treating in-stent restenosis (ISR) in lower extremity arteries.
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