The use of surgical simulators is important to assess competence, plan complex cases and develop skills, but they “do not replace clinical and surgical experience,” according to José Fernandes e Fernandes (Lisbon Academic Medical Centre and Lisbon Cardiovascular Institute, Lisbon, Portugal), who spoke at the 2017 VEITHsymposium (14–18 November, New York, USA).
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).
Gore has announced the first implant of the Gore Excluder Conformable abdominal aortic aneurysms (AAA) endoprosthesis in the USA. The procedure took place on 19 December, 2017 at Maimonides Medical Center in New York, USA by Robert Rhee, chief of Vascular and Endovascular Surgery, and national principal investigator.
ReCor Medical announced today randomisation of its 146th, and final, subject in the SOLO cohort of its RADIANCE-HTN study. RADIANCE-HTN, ReCor’s study of its Paradise renal denervation system in people with hypertension, involves two study cohorts: “SOLO”, whose subjects are removed from anti-hypertensive medication, and “TRIO” whose subjects are put on standardised medication. Both cohorts are randomised, blinded, sham-controlled, and powered independently for efficacy.
Fenestrated or branched endovascular aneurysm repair (F/BEVAR) for thoracoabdominal or complex aortic aneurysm patients “is not cost-effective at two years” compared with open repair, particularly for patients with para/juxtarenal abdominal aortic aneurysms and infradiaphragmatic thoracoabdominal aortic aneurysms.
Avinger, a developer of treatments for peripheral artery disease (PAD), has announced the first use of their next generation Pantheris lumivascular atherectomy system. The device was used by vascular surgeon Arne Schwindt to treat patients at St Franziskus Hospital in Münster, Germany.
XableCath, a clinical stage medical device company, announced its XableCath blunt tip support catheter has received clearance from the US Food and Drug Administration (FDA). The blunt tip catheter facilitates true lumen passage of lesions, both above and below the knee, in the peripheral vasculature. Procedures using the XableCath blunt tip catheters can be performed quickly and safely, allowing physicians to more effectively treat peripheral arterial disease (PAD).
Terumo and Quirem Medical, a commercial stage Dutch medical technology company that focuses on radioembolization, have announced that Terumo has made an equity investment in Quirem Medical.
Dedicated venous stents can be effectively used to relieve outflow obstruction at one year following thrombotic disease in both the acute and chronic setting, according to the prize-winning research presented at the European Venous Forum (EVF; 2–4 July, Saint Petersburg, Russia). Prakash Saha, King’s College London, Guy’s and St Thomas’ NHS Foundation Trust, London, UK, said, however, that as deep venous reconstruction is challenging, complex cases may require reintervention or adjunctive procedures.
The National Institute for Health and Care Excellence (NICE), the medicines cost-effectiveness body for England and Wales, has recommended a new treatment to help patients suffering from blood clots in the legs and lungs.
The first patient has been enrolled in ETNA-AF-Europe (Edoxaban treatment in routine clinical practice – atrial fibrillation – Europe), and ETNA-VTE-Europe (Edoxaban treatment in routine clinical practice – venous thromboembolism – Europe) has commenced.
Results of the landmark CATCH (Comparison of Acute Treatments in Cancer Haemostasis) study were published in The Journal of American Medical Association (JAMA), comparing innohep (tinzaparin), a low-molecular weight heparin (LMWH), with warfarin in patients with cancer-associated thrombosis.
BTG announced on 6 August 2015 that Health Canada has issued a notice of compliance approving polidocanol injectable foam (Varithena, BTG) for the treatment of incompetent great saphenous veins, accessory saphenous veins, and visible varicosities of the great saphenous vein system, above and below the knee.
A review of haemodynamics in stent development, published in Annals of Biomedical Engineering, suggests that the re-introduction of spiral flow after endovascular treatment for peripheral artery disease (PAD) may support endothelial function and increase patency rates.
Medtronic announced on 2 November 2015 the initiation of the REALITY Study (Directional atherectomy + drug-coated balloon to treat long, calcified femoropopliteal artery stenoses) to evaluate patient outcomes following adjunctive use of directional atherectomy and drug-coated balloon treatment of patients with symptomatic peripheral arterial disease in long, calcified lesions in the superficial femoral artery and/or popliteal artery. The study is sponsored and will be managed by VIVA Physicians, and will have multidisciplinary representation in leadership.
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