Having received CE mark approval in July and Health Canada approval in August of last year, FlowAid Medical Technologies has now received US Food and Drug Administration (FDA) clearance for its FA100 SCCD (Sequential Continuous Contraction Device) for the following indications: increase of local blood circulation, immediate post-surgical stimulation of calf muscles to prevent venous thrombosis, prevention or retardation of disuse atrophy and oedema reduction. FlowAid says that the FA100 SCCD is the first device of its kind cleared by the FDA for the indication of oedema reduction.
Two-year outcomes of the VeClose pivotal trial have been reported, showing a 94.3% closure rate and “continued non-inferiority results to radiofrequency ablation” when using the VenaSeal cyanoacrylate embolic adhesive closure system (Medtronic). The data were presented by Raghu Kolluri, from OhioHealth Vascular Institute Columbus, USA, at the 2016 VEITHsymposium (15–19 November, New York, USA).
A Dutch study of greater saphenous vein insufficiency patients has found that mechanochemical ablation (MOCA; ClariVein, Vascular Insights) is an effective and safe treatment with low postoperative pain and fast recovery.
Fresh data from a Turkish CAPE (cyanoacrylate adhesive perforator embolisation) trial indicate that the method is “as effective as endovenous thermoablative techniques, without the risks of potential inadvertent thermal lesions” for treating incompetent perforating veins. The presentation was given by Kursat Bozkurt, Istanbul University, Istanbul, Turkey, at the 2016 VEITHsymposium (15–19 November, New York, USA).
TVA Medical has provided clinical updates involving its everlinQ endoAVF system at the 2017 Leipzig Interventional Course (LINC; 24-17 January, Leipzig, Germany).
The All Party Parliamentary Group on Vascular Disease has released its latest report on patient access to technologies for the diagnosis and treatment of peripheral arterial disease.
The Gore Viabahn VBX balloon expandable endoprosthesis has received US Food & Drug Administration (FDA) approval for treatment of de novo or restenotic lesions found in iliac arteries, including lesions at the aortic bifurcation. This marks the availability of the only balloon expandable stent graft with an indication for the iliac artery.
The use of hypnosis during endovascular aneurysm repair (EVAR) may improve haemodynamic and respiratory stability and allow faster patient recovery, according to a presentation given at the 2016 VEITHsymposium (15–19 November, New York, USA).
While the long-term durability of fenestrated endovascular repair (FEVAR) has been established, the need for accurate procedural planning may act as a barrier to widespread adoption. At the 2016 VEITHsymposium (15-19 November, New York, USA), Benjamin Starnes, University of Washington, Seattle, USA, suggested that this barrier may be overcome thanks to AortaFit automated planning software.
Remote monitoring of bypass flow using an implantable piezoelectric sensor, which can also be placed on stents, has shown successful and reliable transmission of signal over the first 30 days of an in vivo study. The experiment, which used the Graftworx system in an ovine carotid artery bypass model, raises the possibility of remote monitoring of vascular flow using wireless technology.
Despite homogenous professional society recommendations, significant global variation still exists in the management of abdominal aortic aneurysms, a US study published in Circulation has shown. The variation is especially marked in intact aneurysm diameter at repair, use of endovascular aneurysm repair (EVAR) and the treatment of elderly patients, the authors, led by Adam W Beck (Birmingham, USA) and Kevin Mani (Uppsala, Sweden), report.
QT Vascular has signed a definitive agreement with Medtronic, for the worldwide distribution of its Chocolate percutaneous transluminal angioplasty (PTA) catheter for a period of five years and automatically renewable for two additional one-year periods. The parties continue to negotiate other aspects of their commercial relationship.
As the second year of enrolment draws to a close, the Best Endovascular vs. Best Surgical Therapy in Patients with Critical Limb Ischemia (BEST-CLI) trial is well on its way to attaining its target enrolment. In the process, it is serving as a catalyst for an ongoing discussion of how CLI, which affects 8–10 million people worldwide, is optimally managed. This multidisciplinary trial, led by Alik Farber (Boston Medical Center, Boston, USA), Matthew Menard (Brigham and Women’s Hospital, Boston, USA) and Kenneth Rosenfield (Massachusetts General Hospital, Boston, USA), is currently enrolling patients at 135 sites in the USA and Canada. BEST-CLI both encourages and facilitates specialists who treat CLI at a given trial site to work together for the common good of patients, and in so doing, harnesses the talents of all contributing specialties. Key to successful engagement in the effort is the ability of participating investigators to set aside their individual treatment biases and acknowledge the absence of reliable scientific evidence to support their impulses.
Mahmood Razavi and George Adams, the national co-principal unvestigators of Mercator MedSystem’s DANCE trial, have each presented comprehensive 13-month data from the trial during late-breaking sessions at International Symposium on Endovascular Therapy (ISET; 4-8 February, Holywood, USA) and Leipzig Interventional Course (LINC; 24-27 January, Leipzig, Germany), respectively.
Flow Forward Medical has announced the completion of a preclinical study and a computational fluid dynamics study supporting continued development of the company’s Arteriovenous Fistula Eligibility (AFE) system. The AFE system is a small external blood pump designed for temporary use to stimulate flow-mediated vein dilation to make more haemodialysis patients eligible for creation of arteriovenous fistula (AVF) and arteriovenous graft (AVG) vascular access sites, and to increase success rates after AVF and AVG surgeries.
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