Ethicon has announced positive new data from the clinical development program for Evarrest fibrin sealant patch. More than 92% of patients treated during aortic reconstruction surgery with Evarrest achieved haemostasis on the first attempt within three minutes and maintained haemostasis throughout the duration of the surgery, compared with 33% for those treated with Baxter’s TachoSil patch and 46% for those treated with the standard of care—manual compression with or without an additional topical absorbable haemostat.
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.
Gore has completed primary enrolment in the Gore Excluder iliac branch clinical study, a prospective, multicentre, non-randomised, single-arm study designed to assess the safety and effectiveness of the Excluder iliac branch endoprosthesis in treating common iliac artery aneurysms or aorto-iliac aneurysms.
This year, the Charing Cross Symposium is launching the CX Live Case method. Thomas Zeller (Universitäts-Herzzentrum Freiburg – Bad Krozingen, Bad Krozingen, Germany), course director of the CX Live Peripheral Arterial Cases, will link the live case demonstrations from Bad Krozingen with topics to be discussed in the CX Main Programme – Peripheral Arterial Controversies at the Charing Cross Symposium 2015.
Boston Scientific will now distribute the Lutonix 035 drug-coated balloon in the USA under a limited distribution agreement reached with Bard. Terms of the agreement were not disclosed.
Data from a clinical trial assessing the safety and efficacy of the Castor Branched Aortic Stent-Graft System for the treatment of thoracic dissection has been released by MicroPort, the device’s manufacturer.
At the Leipzig Interventional Course (LINC 2015), Stephan Duda presented findings from the ILLUMENATE FIH (first-in-human) study that demonstrate primary patency at 12 months of 89.5% in the pre-dilation plus drug-coated balloon group and 77.5% in the direct balloon group, when using the Stellarex drug-coated balloon.
Data presented at the Leipzig Interventional Course 2015 (LINC, 27– 30 January, Leipzig, Germany) demonstrate significant improvement in dissection repair with the Tack Endovascular System (Intact Vascular).
Transcatheter Technologies is further expanding its product platform to include an endoVascular aortic repair (EVAR) device: Tumbao
A European multicentre analysis of 123 patients treated for mycotic aortic aneurysms with endovascular repair demonstrates this approach is feasible, with 91% survival at 30 days, and for most patients a durable option. The authors, however, also show that a significant number (19%) of fatal infection-related complications occur.
In November 2014, Jotec received CE mark approval for the new E-tegra AAA Stent Graft System. The stent graft system is indicated for endovascular treatment of infrarenal abdominal aortic aneurysms and, according to the company, incorporates numerous innovative technical solutions with respect to implant and delivery system.
The early results obtained using this new minimally invasive technique that uses both coil embolization and foam as a sclerosing agent were published in the journal Phlebology in December 2014. The study shows that the technique, which associates a mechanical interruption of the sapheno-femoral junction to classic sclerotherapy with no need for surgery or anaesthesia, is effective, nearly painless and appears cost-effective in a small group of patients with short follow-up.
According to a study presented at the 2014 European Society for Vascular Surgery (ESVS) meeting (23–25 September, Stockholm, Sweden), a standardised perioperative protocol for immediately diagnosing spinal cord ischaemia after thoracic endovascular aortic aneurysm repair (TEVAR) for the management of thoracoabdominal aortic aneurysms may lead to improved recovery after the complication.
Preliminary results from the INNOVATION study indicate that Cordis’s Incraft stent graft is not associated with any type Ia or type III endoleaks at three years for patients undergoing endovascular aortic aneurysm repair (EVAR). They also show that the device is associated with a freedom from sac increase rate of 95.6%.
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