AccuVein, creator of the AV300, the world’s only hand-held, non-contact vein illumination device, announced that to date it has sold and installed 64 units to Banner Health, one of the largest nonprofit healthcare systems in the USA.
Bard has acquired Lutonix for a purchase price of approximately US$225 million paid at closing, with an additional US$100 million to be paid upon US premarket approval of Lutonix’s drug-coated percutaneous transluminal angioplasty (PTA) balloon. The transaction was announced in December 2011 and is structured as a merger.
Pulmonary embolism continues to be a major cause of morbidity and mortality in the United States. In most clinical situations, anticoagulation is the preferred form of therapy. The efficacy of inferior vena cava filters is still discussed controversially since several factors for effective pulmonary embolism prevention have to be considered.
Boston Scientific reports positive outcomes from the CABANA post-approval study of the Carotid Wallstent Monorail Endoprosthesis used in conjunction with its FilterWire EZ embolic protection system in routine clinical practice.
Boston Scientific launched its Coyote balloon catheter, a highly deliverable and ultra-low profile 0.014 inch balloon dilatation catheter designed to treat patients undergoing peripheral angioplasty procedures below the knee. The company has begun marketing the product in the USA, Europe and other international markets.
Boston Scientific announced the US launch of the TruePath CTO device, designed to facilitate the crossing of chronic total occlusions (CTOs) within the peripheral vasculature.
Medtronic has announced positive results at one-year follow-up of the Complete SE (selfexpanding) vascular stent study for the treatment of atherosclerosis in the superficial femoral artery (SFA).
Health Canada has approved the Zenith low profile AAA endovascular graft (Zenith AAA LP) from Cook Medical in Canada. This device has a low-profile delivery system diameter of 16 Fr and simplified deployment compared to previous Zenith endograft systems for precise delivery of the graft to the desired position in the patient’s aorta.
Cook Medical has launched its first drug-eluting balloon (DEB) approved to treat stenotic or occlusive disease in the peripheral vascular system. The Advance 18 PTX will be sold across Europe following CE mark approval in December 2011 after notification from Lloyds Register Quality Assurance, London.
Medtronic announced the CE mark and international launch of the Endurant II AAA stent graft system for the treatment of abdominal aortic aneurysms through endovascular aortic repair (EVAR).
Eurocor GmbH unveiled the first insights of the ongoing Freeway stent study during the Eurocor Symposium at Leipzig Interventional Course (LINC), Germany.
The US Food and Drug Administration (FDA) has approved the EverFlex Self-Expanding Peripheral Stent System (Covidien) for use in the superficial femoral artery and/or the proximal popliteal artery. The EverFlex system, which has been approved for peripheral indication in international markets since 2006, is now available in the United States, including a 200mm stent length.
The US Food and Drug Administration FDA has granted 510(k) clearance to AngioDynamics to market its everTouch Direct Procedure Kit for use with the VenaCure EVLT Laser Vein Ablation System (AngioDynamics).
On 13 January, The US Food and Drug Administration (FDA) expanded the approved usage for Gore’s TAG Thoracic Endoprosthesis to include treatment of life-threatening tears or thoracic aortic transection.
The US Food and Drug Administration has approved the Ovation abdominal stent graft system (TriVascular) under a humanitarian device exemption (HDE). According to TriVascular, this is the first HDE granted by the FDA in the field of abdominal aortic aneurysm treatment. With this approval, patients previously ineligible for EVAR will gain access to a minimally invasive therapy.
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