The results of the BAROSLEEP study, published in the December issue of the European Journal of Vascular and Endovascular Surgery, show that microstructural white matter damage is associated with poor outcome in peripheral arterial disease patients with claudication requiring surgical revascularisation. Timo Laitio, Division of Perioperative Services, Intensive Care Medicine and Pain Management, Turku University Hospital, Turku, Finland, the study lead investigator, spoke to Vascular News about the study and its clinical implications.
Theodosios Bisdas, Department of Vascular Surgery, University Clinic & St Franziskus Hospital of Munster, presented in-hopsital outcome results from the real-world, critical limb ischaemia CRITISCH registry at the Leipzig Interventional Congress (LINC, 27–30 January, Leipzig, Germany). In the study, more than 50% of patients treated for critical limb ischaemia in Germany underwent endovascular therapy.
The US Centers for Medicare and Medicaid Services has approved a pass-through payment for Bard’s Lutonix drug-coated balloon under the Medicare hospital outpatient prospective payment system. This approval follows a unanimous favourable recommendation from the Food and Drug Administration (FDA)’s Circulatory Systems Devices Advisory Panel, which voted 9 to 0 on each question of safety, efficacy and benefit/risk.
In the first-line treatment of non-resectable metastatic colorectal cancer, the preliminary analysis of the SIRFLOX study results does not show a statistically significant improvement in overall progression-free survival ie, at any site. However, the study does show a statistically significant improvement in progression-free survival in the liver.
Bracco Imaging, through its business unit Bracco Injeneering SA, has announced the availability of its EmpowerCTA+, an advanced engineering contrast injection system that puts the radiologic technologist in control in the computed tomography suite.
Lombard Medical has announced that it has received approval for the AorFlex delivery system from the Japanese Ministry of Health, Labour and Welfare. Commercial sales will follow reimbursement approval, which the company anticipates receiving in April, and the company will receive and ship a significant stocking order in advance of the commercial launch.
Avinger announced on 12 March that it has completed enrolment of its VISION clinical study, which is designed to evaluate the safety and efficacy of the company’s Pantheris system. According to Avinger, the Pantheris catheter is the only device to combine directional atherectomy with real-time intravascular imaging to aid in the removal of plaque from diseased lower extremity arteries.
The Protégé GPS self-expanding peripheral stent system (Medtronic) has received approval from the FDA for the treatment of stenotic lesions of the common and external iliac arteries. The news follows the nine-month results of the DURABILITY Iliac study, which were presented at the VIVA conference in Las Vegas in November 2014.
A study published in the European Journal of Vascular and Endovascular Surgery shows that in the carotid arteries, stent malapposition is more frequent with closed-cell stents while plaque prolapse is more common with open-cell stents. Gianmarco de Donato, Department of Surgery, Vascular and Endovascular Surgery Unit, University of Siena, Siena, Italy, explains the rationale behind the study, its implications and future directions.
CE mark has been awarded to the new rotating thumbwheel deployment system for Cook Medical’s Zilver PTX drug-eluting peripheral stent. The new system, which is now available for purchase in the UK, Ireland, Germany, Spain and Italy, provides simple deployment for what Cook Medical says is the world’s first and only approved drug-eluting stent for the superficial femoral artery.
In mid-January, a patient called me from her pharmacy, frantic. Her asthma inhalers came to $168 — a sum that she hadn’t been prepared for. But she can’t live without those inhalers, so she withdrew cash from her meager savings account and skipped her blood pressure pills for that month.
CryoLife has provided an update on its ongoing litigation with CR Bard and some of its subsidiaries regarding PerClot. The US District Court for the District of Delaware has allowed CryoLife’s declaratory judgement lawsuit against CR Bard’s Medafor subsidiary to proceed. The court also granted Medafor’s motion for a preliminary injunction with respect to CryoLife’s marketing and sale of PerClot Topical in the USA. CryoLife is currently awaiting the court’s order, which it expects will provide details regarding the scope of the injunction.
Medicare approves transitional pass-through payment for outpatient use of Medtronic’s drug-coated balloon Medtronic plc has announced that the US Centers for Medicare and Medicaid Services has approved a transitional pass-through payment for the company’s IN.PACT Admiral drug-coated balloon under the Medicare hospital outpatient prospective payment system, removing a potential barrier to patient access to this new medical device, which may represent a significant improvement to the standard of care for peripheral arterial disease in the upper leg.
Royal Philips has completed the acquisition of Volcano Corporation. Volcano’s financial results will be consolidated as part of Philips’ image-guided therapy business group as of 17 February, 2015.
Distal Access has announced the US Food and Drug Administration (FDA) clearance of the Spinr high-performance Guidewire Controller for use in the coronary and peripheral vasculature.
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