On 21 January 2013, TriVascular announced FDA approval of the Ovation Prime Abdominal Stent Graft System for the treatment of abdominal aortic aneurysms. Ovation Prime builds upon the strong clinical experience of TriVascular’s Ovation stent graft by improving delivery system attributes to further enhance ease of use. Delivered through a 14F (4.7mm) outer diameter catheter, Ovation Prime is the lowest profile commercially available system for endovascular aortic repair (EVAR).
Eurocor unveiled interim results of the ongoing Freeway Stent Study on 17 January 2013 at IROS (Interventionell Radiologische Olbert Symposium), Berlin, Germany. The study was presented during the Free Paper Session 2 by Josef Tacke, Klinikum Passau, Germany. The multicentre, open, prospective randomised trial investigates the prevention of restenosis by drug-eluting balloon dilatation (Freeway) after stenting with a nitinol stent versus dilatation with standard balloon angioplasty after stenting with a nitinol stent in the treatment of superficial femoral artery or popliteal artery lesions.
Las mujeres con un trastorno hormonal llamado síndrome de ovario poliquístico (SOP) y que usan píldoras anticonceptivas tienen el doble de riesgo de desarrollar coagulos sanguíneos que otras usuarias de la píldora.
AngioScore, Inc., a developer of novel angioplasty catheters for use in the treatment of cardiovascular disease, today announced the launch of its new 100 mm length AngioSculpt PTA Scoring Balloon Catheters for the treatment of peripheral artery disease (PAD) below the knee (BTK)
Expanding its role in the treatment of peripheral artery disease, Medtronic, Inc. (NYSE: MDT) today announced the CE (Conformité Européene) mark and international launch of its Complete SE (self-expanding) vascular stent for use in the lower extremities –– specifically, the superficial femoral arteries (SFA) and proximal popliteal arteries (PPA), which supply blood to the legs.
Gore has received Food and Drug Administration (FDA) approval for the new large diameter 35mm trunk-ipsilateral leg and 36mm aortic extender components, as well as the lower profile 31mm diameter trunk-ipsilateral leg and 32mm aortic extender components of the Gore Excluder AAA Endoprosthesis. According to the company, the new components provide physicians with a proven and durable endovascular option to treat abdominal aortic aneurysms (AAA).
Gore has announced the availability of the new Q50 PLUS Stent Graft Balloon Catheter. According to a company release, the new device features enhanced radial expansion force to aid in endograft modeling and sealing, and a new stopcock design to improve operator control.
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.
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