Medtronic’s VenaSeal closure system has been granted pre-market approval (PMA) from the US Food and Drug Administration (FDA) for the treatment of symptomatic venous reflux.
Merit Medical, as part of its ThinkRadial programme, now offers, according to a press release, a new one-of-a-kind vascular training model at events throughout the world. The press release reports that the model is an example of the company’s commitment to provide in-demand, extensive radial training to further the advancement of physicians and their fields of medicine.
Renal Dynamics’ (ReDy) third-generation Renal Denervation System has been granted CE mark approval for the treatment of resistant hypertension and is now commercially available on the European market.
Toshiba announces the launch of the largest and most advanced commercially available mobile CT scanner in the UK. The new mobile imaging innovation already serves 12 CT imaging centres in the UK, travelling 3,500 miles per week from site-to-site.
Hansen has announced the completion of the world’s first clinical procedure using the Magellan Robotic Microcatheter Driver as part of the clinical study, “Embolization procedures in peripheral vasculature”.
Based on the success of its V-Probe variable ice cryoprobe which is used for prostate cryoablation procedures, Endocare has introduced a right angle version of the product. This modification allows the cryoprobe to be used in CT scanners and other limited access areas.
Endologix has received Shonin approval from the Japanese Ministry of Health, Labour and Welfare.
Just weeks after 2015 country approval of Cook Medical’s Zenith Alpha abdominal endovascular graft, the University of Western London Health Sciences Centre in London, Ontario, has treated the first patient with the device as part of Cook’s Canada commercial launch.
Bayer and its development partner Janssen Pharmaceuticals presented results from two real world studies—the non-interventional XALIA study in patients with deep vein thrombosis (DVT) and a study looking at patients with cancer-associated thrombosis on 8 December 2015. Results from the two studies were presented at the 2015 ASH Annual Meeting, and XALIA findings were also simultaneously published in the Lancet Haematology.
The devices are intended for the introduction of interventional devices during peripheral vascular procedures, and were recalled on 19 November due to the risk of shaft separation. The US Food and Drug Administration (FDA) has classified the action as a Class-1 recall.
A specific type of tissue microphage plays a key role in maintaining healthy arteries after inflammation, according to research from the University of Toronto, Canada. Investigators found that this group of tissue macrophages is created, and operates, separately from bone marrow macrophages.
Results from the GAIA-DEB study published online ahead of print in the Journal of Endovascular Therapy show no sustained benefit of dilation with a drug-coated balloon before the placement of the Igaki-Tamai bioresorbable scaffold in the superficial femoral artery. In the study, the use of the paclitaxel-coated balloon had no impact on the prevention of restenosis after 12 months.
Endovascular aneurysm sealing using the Nellix (Endologix) device in an acute setting “appears safe, feasible and concordant with the literature of endovascular aneurysm repair (EVAR),” according to a study published in the Journal of Endovascular Therapy.
Enrolment in the MobiusHD (Vascular Dynamics) CALM (Controlling and lowering blood pressure with the MobiusHD) prospective multicentre safety study for treating resistant hypertension is continuing, following interim data suggesting that the device is safe and effective for lowering blood pressure.
The Valiant Captiva (Medtronic) thoracic stent graft has demonstrated positive outcomes at two years when used to treat acute complicated type B aortic dissections. Ali Azizzadeh, Memorial Herman Heart and Vascular Institute, Houston, USA, told delegates at the Vascular Interventional Advances (VIVA) meeting (2–5 November, Las Vegas, USA) that the stent graft was implanted with 100% delivery and deployment success and acceptable rates of adverse events. Session chairman, Michael R Jaff, Massachusetts General Hospital, Boston, USA, called the results “breath-taking”.
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