Data from the PEGASUS-TIMI 54 trial indicate that the use of aspirin plus ticagrelor (Brilinta, AstraZeneca) in patients with prior myocardial infarction and concomitant peripheral arterial disease is associated with a risk reduction in major adverse cardiovascular events and ischaemic lower limb events.
Lombard Medical has announced that it has expanded the European launch of its new Altura endovascular stent graft system to The Netherlands and Spain.
The CardioVascular Coalition (CVC)—a group of community-based endovascular care providers, physicians, and manufacturers created to advance community-based solutions designed to improve awareness, prevention, and intervention of vascular disease—has said that a new report published in Vascular underscores the value office-based endovascular care offers to patients, including individuals diagnosed with peripheral artery disease (PAD).
Shockwave Medica has announced clearance from the US Food and Drug Administration (FDA) of the Lithoplasty system for the treatment of calcified plaque in patients with peripheral arterial disease.
Silk Road Medical has announced the Centers for Medicare and Medicaid Services (CMS) has extended coverage for the transcarotid artery revascularisation (TCAR) procedure under the existing National Coverage Determination 20.7. TCAR is eligible for coverage when patients are treated with any FDA-approved proximal embolic protection device and FDA-approved carotid artery stent system indicated for the transcarotid approach and entered into the new national TCAR Surveillance Project. The TCAR Surveillance Project is sponsored by the Society for Vascular Surgery (SVS) Patient Safety Organization (PSO) and has been deemed scientifically valid and clinically relevant by the Food and Drug Administration (FDA).
PQ Bypass, a medical technology company pioneering a fully percutaneous approach to femoral-popliteal bypass surgery, announced on 14 September 2016 the addition of several medical technology industry veterans to its leadership team and Board of Directors. Most notably, Peter Wehrly has assumed the role of president and chief executive officer (CEO), with Heather Simonsen joining as vice president of Global Marketing and Christopher Owens as the newest member of the Board of Directors.
The US Food and Drug Administration (FDA) has approved Medtronic’s IN.PACT Admiral drug-coated balloon as a treatment for in-stent restenosis in patients with peripheral artery disease. This is the first drug-coated balloon to gain approval to treat in-stent restenosis in the USA.
A surveillance project to evaluate the safety and effectiveness of transcarotid artery revascularisation (TCAR) in comparison with carotid endarterectomy (CEA) is being launched by the Society for Vascular Surgery Patient Safety Organization (SVS PSO).
Biotronik has showcased the efficacy of its lower limb intervention portfolio at a scientific symposium at CIRSE 2016 (10–14 September, Barcelona, Spain). Encouraging data were presented for the Pulsar-18 bare metal self-expanding stent as well as for the Passeo-18 Lux drug-coated balloon, both standalone and together in combination treatment of superficial femoral artery disease.
Vivasure Medical has completed a Series C financing of €16.2m (US$18.3m). The round was led by Life Sciences Partners (The Netherlands), investing from its LSP Health Economics Fund, and co-led by Evonik Venture Capital (Germany), alongside Panakes Partners (Italy) with returning Series A and B investors led by Fountain Healthcare Partners (Ireland).
Twelve-month follow-up of the everolimus-eluting, Absorb bioresorbable vascular scaffold (Abbott Vascular) below the knee has demonstrated “excellent safety, patency, and freedom from target lesion revascularisation,” in the treatment of focal tibial and distal popliteal lesions, according to a paper published in JACC: Cardiovascular Interventions.
The new Excluder iliac branch endoprosthesis (Gore) is safe and effective at treating aortoiliac aneurysms and common iliac artery aneurysms, maintaining blood flow into the internal iliac artery, and preventing the complications associated with internal iliac artery sacrifice, Darren Schneider, New York, USA, told delegates at the Vascular Annual Meeting (9–11 June, National Harbor, USA). Another study, with the Cook Medical Zenith Branch Endovascular Graft – Iliac Bifurcation, showed minimal additional perioperative time, no increase in perioperative morbidity and excellent long-term branch patency with the device.
Toshiba Medical Systems has announced the acquisition of Belfast-based Medical Imaging NI Limited. Medical Imaging NI has been a Toshiba Medical Systems partner for 25 years as a distributor for imaging equipment in Northern Ireland.
The CardioVascular Coalition (CVC)—a group of community-based cardiovascular and endovascular care providers, physicians, and manufacturers created to advance community-based solutions designed to improve awareness, prevention, and intervention of vascular disease—is urging healthcare leaders, policymakers, patient advocates and other stakeholders to join them in recognising September as “Peripheral Artery Disease (PAD) Awareness Month”, a time designated to increasing awareness about the disease and treatment options to save limbs and lives.
Despite “overwhelming data” demonstrating the efficacy of antiplatelet therapy in heart disease and stroke, data for antiplatelet therapy for peripheral arterial disease (PAD) are “less compelling”, according to the investigators of the EUCLID trial, which will investigate whether treatment with ticagrelor versus clopidogrel, given as antiplatelet monotherapy, will reduce the incidence of cardiovascular and limb-specific events in patients with symptomatic PAD.
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