Restoring diminished levels of a protein shown to prevent and reverse heart failure damage could also have therapeutic applications for patients with critical limb ischemia (CLI), suggests a new preclinical study published online in Circulation Research from researchers at the Center for Translational Medicine at Thomas Jefferson University .
October 11, 2012—Avinger, Inc. (Redwood City, CA) announced results for its CONNECT II global clinical trial. CONNECT II’s Coprincipal Investigator Matthew Selmon, MD, from the Heart Hospital of Austin in Austin, Texas, presented the data at the VIVA 2012: Vascular Interventional Advances Conference 2012 in Las Vegas, Nevada. Arne Schwindt, MD, of St. Franziskus Hospital in Muenster, Germany was the Coprincipal Investigator with Dr. Selmon.
A cost-effectiveness analysis of the OVER trial has shown that endovascular repair of abdominal aortic aneurysms (EVAR) resulted in lower costs and improves survival than open repair after the initial hospitalisation period. However, after two years there was no statistically significant difference between the two techniques.
Spectranetics has announced the US launch of the Tapas catheter at the 2012 Vascular Interventional Advances (VIVA) conference (Las Vegas, USA, 9–12 October). The device is manufactured by ThermopeutiX and distributed by Spectranetics. The Tapas catheter allows treatment of long peripheral vascular segments with only one device.
Interventional News has learned from industry sources at the CIRSE annual meeting (Lisbon, Portugal, 15–19 September) that Bayer HealthCare is looking into discontinuing the production of the Cotavance drug-eluting balloon, using the Paccocath technology, as there have been problems of drug adhesion to the balloon. Industry sources told Interventional News that there have been cases of drug coming off the surface of the balloon before implantation. On being questioned on the topic, Bayer said that it has suspended its development programme for Cotavance only in the United States, due to recent regulatory changes – regulatory pathway in the USA is now seven years.
Boston Scientific has begun the United States and European launch of its Victory guidewire, designed to facilitate crossing of resistant lesions and the placement and exchange of balloon catheters or other interventional devices within the peripheral vasculature.
October 10, 2012—At the VIVA 2012: Vascular InterVentional Advances meeting in Las Vegas, Tony Das, MD, presented findings from the CONFIRM series during a Late-Breaking Trials session. CONFIRM was conducted to better understand the potential advantages of the use of the Diamondback orbital atherectomy system (OAS) (Cardiovascular Systems Inc. [CSI], St. Paul, MN) in real-world patients with calcified infrainguinal disease.
October 11, 2012—Matthew Johnson, MD, outlined plans for the PRESERVE (Predicting the Safety and Effectiveness of Inferior Vena Cava Filters) study during a Late-Breaking Trials session at the VIVA 2012: Vascular InterVentional Advances meeting in Las Vegas.
Volcano has announced it has received FDA clearance and the CE mark to market its new Visions PV .035 Digital IVUS Catheter in both the USA and Europe. The new intravascular ultrasound catheter is designed to image large vessels and facilitate the use of less iodinated contrast in endovascular procedures.
Medtronic announced the US and international launches of the Amphirion Plus Percutaneous Transluminal Angioplasty (PTA) Catheter for the interventional treatment of atherosclerotically narrowed leg arteries below the knee.
October 9, 2012—Many options exist to treat patients with intermittent claudication due to peripheral artery disease of the femoral and/or popliteal vessel(s). Michael R. Jaff, DO, presented a study on the health economics of peripheral drug-eluting balloons and other therapies during a Late-Breaking Trials session at the VIVA 2012: Vascular InterVentional Advances meeting in Las Vegas.
October 10, 2012—The PFAST-CTOs (Peripheral Facilitated Antegrade Steering Technique in Chronic Total Occlusions) trial was a prospective, multicenter, single-arm study intended to demonstrate the ability of the Viance crossing catheter (Covidien, Mansfield, MA) and Enteer reentry system (Covidien) to facilitate safe and effective intraluminal placement of a guidewire beyond challenging peripheral chronic total occlusions (CTOs) without a significant increase in adverse events as compared to the literature. William A. Gray, MD, presented the final results of PFAST-CTO at VIVA 2012: Vascular InterVentional Advances in Las Vegas during a Late-Breaking Trials Session.
October 10, 2012—Michael R. Jaff, DO, presented 1-year results from the STROLL study during a Late-Breaking Trials session at the VIVA 2012: Vascular InterVentional Advances meeting in Las Vegas. STROLL assessed the safety and efficacy of the SMART nitinol self-expandable stent system (Cordis Corporation, Bridgewater, NJ) in treating patients with obstructive superficial femoral artery (SFA) disease. In the United States, the SMART stent is not approved for use in the SFA, and a premarket approval application is currently under review with the US Food and Drug Administration.
The US Food and Drug Administration (FDA) has given TriVascular premarket approval (PMA) for its Ovation Abdominal Stent Graft System for the treatment of abdominal aortic aneurysms (AAA).
On 5 October, Medtronic announced that patient enrolment in IN.PACT DEEP, a landmark study of its In.Pact Amphirion drug-eluting balloon, has been completed, with initial results expected in 2013.
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