Findings from a review of the United States Food and Drug Administration Manufacturer and User Facility Device Experience (MAUDE) database reveal that complications occur with significantly higher frequency when retrievable inferior vena cava filters are placed than permanent filters. The study is in press in the Journal of Vascular and Interventional Radiology (JVIR).
AngioDynamics has announced obtaining 510(k) clearance for the Celerity tip location system from the US Food and Drug Administration (FDA). The Celerity system has been cleared by the FDA as an adjunct to aid in positioning Peripherally Inserted Central Catheters (PICCs) in adults by providing real time catheter tip location utilising the patient s cardiac electrical activity.
Overcoming a significant roadblock to predictable ablation of soft tissue, Covidien has unveiled an advanced ablation system that offers physicians predictable results regardless of the target location or tissue type. The Emprint ablation system with Thermosphere technology is designed to precisely heat and destroy diseased soft tissue (including liver, lung and kidney), and non-resectable liver tumours.
Daisuke Kamoi, Nagoya Kyoritsu Hospital, Nagoya, Japan, reported on the first-in-man experience of angioscopy-guided chronic total occlusion techniques in peripheral arterial lesions at the EuroPCR congress (20–23 May, Paris, France). The system used in the study was the I-Light angioscopy system from iHeart Medical.
Biotronik has announced that the first patient has been enrolled in the investigator-initiated BIOLUX 4EVER trial. Given the positive results from each of the previous drug-eluting balloon and self-expanding stent trials, investigators were interested in exploring the combined use of the Pulsar-18 self-expanding stent and Passeo-18 Lux drug-eluting balloon to see if the outcome could be improved further. BIOLUX 4EVER will follow the study design of the previously completed, investigator-initiated 4EVER trial, which examined the efficacy of the Pulsar-18 self-expanding stent in the treatment of superficial femoral artery lesions, but this time adding the Passeo-18 Lux drug-eluting balloon to the treatment. The study will enrol 120 patients treated with both products, with the primary endpoint of primary patency at 12 months.
The US Food and Drug Administration (FDA) has approved the Fluency Plus Endovascular Stent Graft from Bard for the treatment of in-stent restenosis in the venous outflow of haemodialysis patients dialysing by either an arteriovenous fistula or access graft.
Avinger has announced that John Pigott of Jobst Vascular Institute, Toledo, USA has enrolled the first patient in VISION. VISION is a global investigational device exemption (IDE) clinical trial, approved by the FDA, to evaluate Avinger’s Pantheris catheter for the treatment of peripheral artery disease.
Boston Scientific Corporation has received CE mark approval for the Ranger paclitaxel-coated percutaneous transluminal angioplasty balloon catheter. The technology is now in full European market launch. The Ranger drug-coated balloon provides physicians with an additional option to treat peripheral artery disease, delivering an anti-stenotic drug to diseased vascular tissue while leaving no permanent implant behind.
Veniti has announced that it has received approval from the United States Food and Drug Administration (FDA) for an Investigational Device Exemption (IDE) to begin the VIRTUS trial of the Vici venous stent system. The Vici venous stent system was designed from inception to be compatible with the unique anatomy and pathophysiology of the venous system. Hundreds of thousands of people around the world suffer from lower-extremity venous disease, and until recently, the only treatment options available involved the use of re-purposed vascular stents originally designed for use in the arterial system.
The Spectranetics Corporation has announced that its wholly-owned subsidiary, AngioScore, launched its new 200mm length AngioSculpt PTA scoring balloon catheters for the treatment of peripheral artery disease above-the-knee.
Cordis Corporation has announced the launch of its Saber percutaneous transluminal angioplasty (PTA) dilatation catheter for the treatment of patients with peripheral arterial disease. The Saber catheter is cleared for use and now available in Europe, the United States and Japan. According to Cordis, this newproduct offers outstanding crossability and a comprehensive offering of balloon sizes on the widely-used .018” over-the-wire platform. Physicians can now treat a wider range of peripheral arterial disease patients with a single balloon brand.
Covidien has announced the commercial launch of its next generation Trellis peripheral infusion system. The redesigned system continues to be the only pharmacomechanical thrombolysis device that enables focused treatment of blood clots that lead to post-thrombotic syndrome. This latest Trellis system has been optimised to enhance drug delivery and the removal of the dissolved clot.
InspireMD has announced that it has concluded enrolment in its CARENET (Carotid embolic protection study using MicroNet) clinical trial. The multi-specialty trial is assessing the peri-procedural safety and efficacy of CGuard systems in the treatment of carotid lesions. The acute procedural performance of the CGuard device was 100% successful for all of the 30 patients enrolled in the trial.
An analysis of aneurysm morphology in the IMPROVE trial presented at the British Society of Endovascular Therapy (BSET) Annual Meeting on 26 June 2014 showed that for long aneurysm necks, mortality after endovascular aneurysm repair (EVAR) and open repair was very similar. Surprisingly, the investigators said, there was “a very strong inverse association between neck length and mortality after open repair”.
Results from a feasibility study conducted in Italy indicate that ultrasound-enhanced paclitaxel delivery inhibits arterial smooth muscle proliferation after balloon angioplasty in peripheral arterial disease. Costantino Del Giudice, Department of Radiology, University Hospital Tor Vergata, Rome, Italy, spoke about the study at the EuroPCR congress (19–23 May, Paris, France).
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