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).
June 19, 2014—Vascular Solutions, Inc. announced the United States market launch of its Gel-Bead embolization spheres for the treatment of hypervascular tumors. Gel-Bead, which received 510(k) clearance from the US Food and Drug Administration in April, will be sold to interventional radiologists who currently embolize hypervascular tumors with microspheres, PVA (polyvinyl alcohol) particles, and gelatin foam slurries.
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.
A press release says the acquisition will result in a combined revenue of US$27 billion, including US$3.7 billion from emerging markets. The transaction is expected to be accretive to Medtronic cash earnings in FY2016 and significantly accretive thereafter.
At a time when obesity, type 2 diabetes, and their complications are a veritable epidemic worldwide, researchers at the University of Montreal and CHUM Research Centre (CRCHUM) recently demonstrated the potential of retinoic acid (RA), a derivative of Vitamin A, in treating obesity and type 2 diabetes and preventing their cardiovascular complications. The findings were presented June 6, 2014 at the Annual Conference of the Canadian Nutrition Society in Saint John s, Newfoundland.
The results from a small, animal study challenge previously unsubstantiated published reports claiming that a five to 10mm “ice ball” margin beyond the tumour is necessary for effective cryoablation.
Data from the LEVANT 2 trial comparing the Lutonix drug-eluting balloon with angioplasty alone in the treatment of peripheral arterial disease show that the primary endpoints of both safety and efficacy were met and superior efficacy and non-inferior safety of Lutonix compared to control angioplasty was demonstrated.
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