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”.
Late aortoenteric fistulae may occur in less than 1% of patients undergoing endovascular aneurysm repair (EVAR), with an increased risk in cases of emergency EVAR or those performed for pseudoaneurysm following previous aortic surgery. The data came from a study presented at the annual meeting of the European Society for Vascular Surgery (ESVS; 23–25 September, Porto, Portugal).
TVA Medical has announced clinical trial results from a prospective, multicentre clinical study evaluating the everlinQ endovascular arteriovenous fistula system. This medical technology creates haemodialysis access using vascular sites not traditionally used by surgeons for people with end-stage kidney disease.
AV Medical Technologies has received US Food and Drug Administration (FDA) for its Chameleon angioplasty balloon catheter.
A comprehensive study published in Anaesthesia has found that the only factor influencing ‘never events’ at individual hospitals is their size.
The 24-month results from the DEBAS clinical trial have been presented at the VEITHsymposium (17–21 November, New York, USA). Biotronik says that DEBAS is the first investigator-initiated trial to demonstrate the efficacy and safety of a novel combination therapy for peripheral artery disease using Passeo-18 Lux drug-coated balloon and Pulsar-18 self-expanding stent to treat peripheral artery disease in a complex patient population.
Endologix has announced the presentation of updated clinical data from the company’s EVAS FORWARD Global Registry, a post-market study that prospectively enrolled patients with abdominal aortic aneurysms who were treated with the Nellix endovascular aneurysm sealing system.
Gore has announced the nominees and opening of voting for the 2016 Pioneers in Performance Awards for North America. The announcement was made at the 2015 VEITHsymposium (17–21 November, New York, USA).
Endologix has announced the start of a physician-initiated registry of the Nellix endovascular aneurysm sealing (EVAS) system used with aortic branch stent grafts for the treatment of patients with complex abdominal aortic aneurysms.
The Excluder iliac branch endoprosthesis has exceeded 1,000 implants worldwide; a milestone that comes two years after the device received the CE mark in Europe. The device is currently commercially available in Europe and Australia, available through special access in Canada and is involved in a clinical trial in the USA.
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