XableCath has announced its XableCath blunt tip support catheter has received clearance from the US FDA. The blunt tip catheter facilitates true lumen passage of lesions, both above and below the knee, in the peripheral vasculature.
PQ Bypass has received conditional approval of its investigational device exemption (IDE) from the US Food and Drug Administration (FDA) to initiate the pivotal DETOUR II clinical trial. As the first-ever pivotal trial for percutaneous femoropopliteal bypass, DETOUR II will evaluate the safety and effectiveness of the DETOUR System in up to 292 patients with lower limb ischaemia due to long blockages (>15cm) in the superficial femoral artery (SFA) caused by peripheral artery disease (PAD).
Royal Philips has announced that it has acquired VitalHealth, a provider of cloud-based population health management solutions for the delivery of personalised care outside of the hospital, for example, in regional care networks.
A study of nearly 62,000 hospitalisations nationwide in the USA has found that more than one in six patients with peripheral arterial disease (PAD) who undergo revascularisation procedures to restore blood flow to blocked leg arteries and other arteries outside of the heart are readmitted to the hospital within 30 days.
W L Gore and Associates has announced the first implant of the Gore Excluder conformable abdominal aortic aneurysm endoprosthesis in the USA. The procedure took place on 19 December 2017 at Maimonides Medical Center in New York by Robert Rhee, chief of Vascular and Endovascular Surgery, and national principal investigator.
A new study suggests thoracic endovascular aortic repair (TEVAR) may be appropriate in uncomplicated Type B aortic dissection (TBAD) based on several anatomic criteria determined by CT imaging.
The registry will combine noninvasive, vascular ultrasound testing data with vascular treatment and outcomes data, making it possible to analyse the relationships between diagnosis and care provided to patients with vascular disease.
Enrolment is complete in the Lutonix below-the-knee trial with BD planning to submit a pre-market approval application to the US Food and Drug Administration (FDA) in late 2018.
The post-market, non-interventional, multicentre, non-randomised, single-arm study will enroll approximately 150 patients across 25 sites in Europe and Russia, and will evaluate the safety and performance of a ChEVAR procedure using the Endurant II/IIs stent graft system (Medtronic) in a real-world setting.
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 revascularisation) clinical trial. The primary six-month endpoint data is expected to be available in the second quarter of 2018.
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.
The first patient was treated in the CONTROL hypertension (HTN)-2 clinical study, the Rox Medical’s pivotal study to evaluate the safety and effectiveness of the Rox Coupler used to create an arteriovenous anastomosis in the iliac vessels, in patients with high blood pressure.
Scientists have discovered new information about a molecule which is part of the body’s tissue repair system. This finding could help treat non-healing wounds and injuries, such as diabetic foot.
Venous specialists from around the globe will meet in Melbourne for the much anticipated 2018 World Congress of Phlebology (UIP; 4–8 February, Melbourne, Australia) hosted by the Australasian College of Phlebology.
The Janssen Pharmaceutical Companies of Johnson & Johnson has announced findings from the US Food and Drug Administration’s (FDA) mini-sentinel assessment, confirming the positive safety and efficacy profile of Xarelto (rivaroxaban) established in the phase III ROCKET AF clinical trials, were published in Pharmacoepidemiology & Drug Safety.
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