TriVascular announced on 15 October 2014 that the FDA has approved the CustomSeal technology for the Ovation Prime System. With the Ovation Prime endograft system, physicians create a customised seal by filling the conformable O-rings with the CustomSeal polymer, effectively completing the last step of the manufacturing process in vivo.
RPS Gambhir (King’s College Hospital, London, UK) told delegates at the European Society for Vascular Surgery (ESVS) annual meeting (23–26 September, Stockholm, Sweden) that they, as clinicians, had a responsibility to report adverse events after a vascular procedure. He also stated that the ESVS “should take the lead” in facilitating user initiated reporting of adverse events.
The FDA has approved the Lutonix 035 drug-eluting balloon (Bard) for percutaneous transluminal angioplasty, after pre-dilatation, for the treatment of de novo or restenotic lesions up to 150mm in length in native vascular disease of the superficial femoral or popliteal arteries with reference vessel diameters of 4–6mm.
ReFlow Medical has announced the initial clinical use of their Wingman35 crossing catheter and speX shapeable support catheter by Andrej Schmidt, Park Hospital Leipzig, Germany. The devices were recently granted CE mark approval for use in the peripheral vasculature.
Endologix has announced that it will conduct the first ever prospective randomised clinical study to compare outcomes in endovascular repair of abdominal aortic aneurysms (EVAR). The LEOPARD study (Looking at EVAR outcomes by primary analysis of randomized data) has been designed to provide an accurate and unbiased assessment of commercially available EVAR devices with a planned enrolment of 600 patients.
The use of antiplatelet therapy and statins has increased over time; however, many patients remain medically undertreated around their vascular surgical procedures. An analysis of the Vascular Quality Initiative (VQI) including data for over 50,000 patients shows that optimal medical therapy improves survival by 26% at five years.
Endologix has completed patient enrolment in the EVAS FORWARD – Global Registry. From October 2013 to September 2014, the registry enrolled 300 patients treated with the Nellix EndoVascular Aneurysm Sealing (EVAS) System at centres in Europe and New Zealand. The registry will provide real-world clinical results to further demonstrate the effectiveness and broad applicability of the Nellix technology.
Operators should be aware of radiation exposure to the head increasing with angulation of the C-arm and limit this manoeuvre, according to a study presented at the ESVS Annual Meeting (23–25 September 2014, Stockholm, Sweden).
A study presented at the European Society for Vascular Surgery (ESVS) Annual Meeting (23–25 September 2014, Stockholm, Sweden) shows that thoracic endovascular aneurysm repair (TEVAR) for the treatment of ruptured type B dissections is feasible, and yields an “acceptable” mortality rate of 16.7%.
Lombard Medical has partnered with the Society for Vascular Surgery Patient Safety Organization (SVS PSO) and M2S to develop a FDA-required post-marketing surveillance programme for Aorfix, an endovascular stent graft to treat abdominal aortic aneurysms (AAA).
W L Gore & Associates has announced that the Food and Drug Administration (FDA) has approved the Viabahn endoprosthesis for interventional treatment of in-stent restenosis in the superficial femoral artery (SFA). Now indicated for the treatment of failed bare metal stents in the superficial femoral artery, the Viabahn device has more vascular indications supported by more level 1 clinical trials than any other self-expanding peripheral stent or stent-graft.
Data from the US PYTHAGORAS clinical trial show that major adverse events are lower in patients treated with Aorfix than with open repair, and similar in patients with less severe anatomies treated with other EVAR devices. Results from the trial were presented by Mark Fillinger MD, for the PYTHAGORAS Investigators, at the Society for Vascular Surgery Annual Meeting (5–7 June, Boston, USA).
Somahlution announced on 22 September 2014 that it has received CE mark approval for DuraGraft, the first-in-class endothelial damage inhibitor (EDI) that uniquely protects vascular endothelium function and its associated architecture. DuraGraft, used as a vascular conduit solution, is a pivotal step in successful coronary artery bypass graft and peripheral bypass surgeries.
Royal Philips has announced the global launch of the newest addition to its portfolio of surgical imaging systems. The Veradius Unity Mobile Surgical C-arm with Flat Detector will be unveiled at the upcoming European Society of Vascular Surgery Annual Meeting (23–26 September, Stockholm, Sweden).
QT Vascular has announced that it has enrolled the first European patients in the ENDURE trial in Germany. Multiple patients have already been enrolled in this study by Andrew Holden, at Auckland City Hospital, Auckland, New Zealand.
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