Despite improved outcomes in recent drug-coated balloon trials, standard balloons still have an important and complementary role to play in treating superficial femoral artery (SFA) disease, said S Hinan Ahmed, San Antonio, USA, at the 2016 New Cardiovascular Horizons annual conference (1–3 June, New Orleans, USA).
Physicians have now treated over 1,000 patients with the Vici Venous Stent. The product received CE mark in October 2013 and was first implanted in January 2014. Subsequently, it has been launched in 13 countries worldwide. Veniti says that the stent design allows the physician to confidently treat the millions of patients suffering from chronic venous disease associated with venous outflow obstruction.
Lombard Medical has received CE mark approval for its IntelliFlex Low Profile (LP) delivery system for the Aorfix endovascular stent graft. This new system will be used for the delivery of the Aorfix endovascular stent graft, the only abdominal aortic aneurysm stent graft with global approval to treat aortic neck angulation up to 90 degrees. The company plans to begin shipments in July to its direct markets in the UK and Germany, and expects a full commercial launch in the other European markets later in the year.
BTG has announced that the US Food and Drug Administration (FDA) has approved an extension of the post-activation shelf life of Varithena (polidocanol injectable foam) 1% to 30 days from seven. The announcement was made on 6 July 2016.
Jotec has announced that it has completed enrolment in the PLIANT (Patients with iliac aneurysm undergoing endovascular stenting with a new generation of low profile E-liac stent graft system) study. PLIANT is an observational, prospective, non-randomised, multicentre, single-arm study to evaluate clinical and technical success as well as safety and feasibility of the E-liac Stent Graft System used in endovascular treatment of unilateral or bilateral aorto-iliac or isolated iliac aneurysm.
Essential Medical announced on 8 July 2016 that it has received investigational device exemption (IDE) approval from the FDA to begin the US clinical trial for Manta, the company’s large bore vascular closure device.
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.
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