The Food and Drug Administration (FDA) has given 510(k) clearance to Rex Medical for its Cleaner15 Rotational Thrombectomy System, indicated for mechanical declotting of occluded native vessel dialysis fistulae and synthetic dialysis access grafts.
Covidien has announced the commercial launch of its OneShot renal denervation system, an over-the-wire balloon-based irrigated catheter technology, for the treatment of hypertension. Placed percutaneously, a company press release explains, OneShot delivers radiofrequency energy in a circumferential manner to the renal arterial wall, and requires only a single treatment per artery. The system received the CE Mark in February 2012 and has been undergoing clinical trial evaluation in New Zealand and Europe. The product will be rolled out in Europe, Middle East, Africa, Asia and Latin America over the next several months.
MINNEAPOLIS – Jan. 15, 2013 – Medtronic, Inc. (NYSE: MDT) today announced Food and Drug Administration (FDA) clearance and U.S. launch of the FlexCath Advance™ Steerable Sheath, a new enhancement to the Arctic Front Advance™ Cryoballoon System. This second-generation sheath has an increased degree of deflection and response, providing greater ease compared to the previous generation in reaching the inferior veins of the heart when delivering and positioning the cryoballoon catheter in the left atrium to treat paroxysmal atrial fibrillation (PAF).
The FDA has approved Cook Medical s Zilver PTX to treat peripheral artery disease, making the device the first drug-eluting stent indicated for PAD in the U.S.
Covidien ($COV) wants to see if its plaque-removing devices can help ward off arterial narrowing in patients with peripheral artery disease, and the company has completed enrollment in a multicenter study that could eventually support an expanded indication for the tech.
Covidien has announced the completion of enrolment in its DEFINITIVE AR (Anti-Restenosis) study. As the third study in the DEFINITIVE trial series, this randomised pilot is designed to address the challenge of preventing restenosis, a common occurrence in patients with peripheral arterial disease (PAD)
PLANO, Texas, Jan. 16, 2013 /PRNewswire/ -- Furthering its commitment to advancing the treatment of patients diagnosed with ESRD (End Stage Renal Disease), Argon Medical Devices, Inc. takes another leap forward with the launch of the Cleaner15 Rotational Thrombectomy System. The addition of Cleaner15 to Argon Medical s product portfolio provides physicians with another weapon in their arsenal to safely and effectively restore patency in occluded arteriovenous fistulae and synthetic grafts.
C.R. Bard ($BCR) won the latest round in a 10-year legal battle against W.L. Gore & Associates when the Supreme Court refused to hear an appeal by Gore in a patent lawsuit over vascular grafts.
Covidien announced on 26 December 2012 a definitive agreement to acquire CV Ingenuity.The companies expect to complete the acquisition in the first quarter of 2013. Financial terms of the transaction were not disclosed.
Covidien ($COV) has wrapped up its acquisition of startup CV Ingenuity, snagging the rights to the company s in-development drug-coated balloon designed to treat peripheral artery disease. The financial terms remain closely kept, but Covidien has said it will increase R&D spending by $20 million in the second half of fiscal 2013, and much of that cash will go into polishing up CV s rapid-release balloon for a regulatory debut.
Sumaria Macdonald, Freeman Hospital, Newcastle, UK, in a presentation at the British Society of Interventional Radiology s (BSIR) Annual Meeting (14–16 November, Bournemouth, UK) told delegates that drug-eluting stents ease severe pain when walking in patients with peripheral vascular disease.
Covidien announced the five-year results of the ClosureFast Long-Term European Multi-Center Study in patients with chronic venous insufficiency in December. The ClosureFast study was conducted prospectively at eight centres in Europe. The Venefit procedure (using the ClosureFast radiofrequency ablation catheter) was used to treat 295 lower limbs in 225 patients diagnosed with superficial venous reflux, the underlying cause of varicose veins and chronic venous insufficiency.
By Nicolas Diehm. Endovascular therapy has matured to be the primary revascularisation strategy for about 90% of patients with peripheral arterial disease (EVEM panel data Q2/2012). Ever since the first percutaneous transluminal angioplasty carried out in Switzerland in 1977, restenosis remains a major drawback of endovascular therapy. Numerous attempts to improve patency after balloon angioplasty including drug treatment approaches, endovascular brachytherapy, bare metal nitinol stents and paclitaxel-coated nitniol stents have been investigated.
Krassi Ivancev, University College and Royal Free Hospital, London, UK, presented at the VEITHsymposium (14-18 November 2012, New York, USA) the experience of complete endovascular graft exclusion of arch aneurysms using a non-custom-made branched arched device.
Flexible Stenting Solutions (FFS) announced on 21 December 2012 that it has received the CE mark and is now authorised to market its 6F reconstrainable FlexStent self-expanding stent system in the European Union. FSS is a developer of next-generation peripheral, neurovascular and biliary stents. This new device combines the advanced FlexStent technology with unique reconstrainable stent delivery technology, the company said.
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