October 23, 2014—ReFlow Medical, Inc. announced US Food and Drug Administration (FDA) marketing clearance of the company’s Wingman35 crossing catheter. The Wingman35 crossing catheter is indicated to be used in conjunction with steerable guidewires to access discrete regions of the peripheral vasculature and enable rapid, routine, off-the-shelf lesion crossing.
During the Second World War, Michael Debakey demonstrated that lives and limbs could be saved using surgical treatment of vascular injuries.1 With the development of endovascular techniques, it became evident that some selected cases of vascular trauma could be treated using an endovascular approach. Injuries to the vascular vessels can be penetrating or blunt and can be the result of violence, accidents, or be iatrogenic in origin.
At the Vascular Interventional Advances (VIVA) 2014 meeting, Covidien announced nine-month results of the DURABILITY Iliac study and the addition of the iliac indication for its EverFlex stent. The nine-month results confirm the safety and effectiveness of the EverFlex and Protégé GPS self-expanding stent systems for the treatment of lesions of the common and external iliac arteries
Medtronic s IN.PACT Admiral drug-coated balloon, used for the treatment of peripheral artery disease in leg arteries above the knee, provided a consistently favourable treatment effect in patients with diabetes in a landmark study of the investigational medical device, which is under review by the US Food and Drug Administration (FDA) for approval
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.
Cookies Sociales
Son esos botones que permiten compartir el contenido del sitio web en sus redes sociales (Facebook, Twitter y Linkedin, previo tu consentimiento y login) a través de sistemas totalmente gestionados por dichas redes sociales, así como los recursos (pej. videos) y material que se encuentra en nuestra web, y que de igual manera se presta y gestiona completamente por un tercero.
Si no acepta estas cookies, no podrá compartir nuestro contenido a través de los botones, y en su caso, no podrás visualizar el contenido de terceros que hayamos incrustado en el sitio.
No las utilizamos