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.
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.
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.
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.
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.
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.
Gore has announced the first patient enrolment in its post-market European registry for the Gore TAG Conformable Thoracic Stent Graft with Active Control System, following its recent European launch in July 2017. The thoracic endovascular aortic repair (TEVAR) device is the first to feature a new delivery system that provides the physician with controlled, staged deployment.
Mercator MedSystems has announced completion of enrolment in the company’s LIMBO-ATX (Lower-limb adventitial infusion of dexamethasone via Bullfrog to reduce occurrence of restenosis after atherectomy-based revascularization) clinical trial. The LIMBO-ATX trial was designed to use Mercator’s proprietary Bullfrog micro-infusion catheter to test a new treatment strategy to potentially improve blood flow and decrease repeat revascularisation procedures in below-the-knee critical limb ischaemia.
Nitiloop has received FDA clearance for its new Nova Cross Extreme and Nova Cross BTK. According to the company, these dedicated microcatheters are joining the Nova Cross product family “combining innovative low profile microcatheter technology with uniquely designed nitinol scaffold providing enhanced guidewire and microcatheter support for safer and more effective lesion crossing”.
At the European Society for Vascular Surgery (ESVS) meeting (19–22 September, Lyon, France), Vascular News spoke to Florian Dick (University of Bern, Bern, Switzerland) about the new Global Vascular Guidelines for chronic limb-threatening ischaemia, which were presented to delegates as part of the scientific sessions. Dick told Vascular News about the main message behind the guidelines, and how they will form a framework around which the evidence base can grow. The guidelines are expected to be published online in the first quarter of 2018.
A 53-year-old woman with a complex aortic malfunction causing a bulging blood vessel attended University Hospital Mainz (Mainz, Germany), having been rejected by several other hospitals due to the risky nature of her required surgery. Bernhard Dorweiler— head of the Department of Vascular Surgery at the hospital—utilised an emerging technology to assist in the careful planning of the surgery.
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