October 23, 2012—Boston Scientific Corporation (Natick, MA) announced that 12-month clinical endpoint data from the ORION trial demonstrated the safety and effectiveness of the Epic self-expanding nitinol stent system in patients with obstructed iliac arteries. ORION Principal Investigator Daniel Clair, MD, presented the results at the TCT 2012: Transcatheter Cardiovascular Therapeutics conference in Miami, Florida.
October 23, 2012—In the Journal of Vascular Surgery, Ronald M. Fairman, MD, et al report 30-day and 12-month results from the VALOR II study of endovascular treatment with the Valiant thoracic stent graft system (Medtronic, Inc., Minneapolis, MN) in patients with descending thoracic aortic aneurysms of degenerative etiology (2012;56:1222–1231). The Valiant stent graft is an evolution of Medtronic’s Talent thoracic stent graft, noted the investigators.
October 23, 2012—John R. Laird Jr, MD, et al published 12-month results from the SALVAGE trial in Catheterization and Cardiovascular Interventions (2012;80:852–859). The aim of the study is to evaluate the safety and effectiveness of treating femoropopliteal in-stent restenosis (ISR) by debulking with an excimer laser (Spectranetics Corporation, Colorado Springs, CO) with adjunctive balloon angioplasty and heparin-coated self-expanding stent grafts (Gore Viabahn endoprosthesis with heparin bioactive surface, Gore & Associates, Flagstaff, AZ) for the treatment of femoropopliteal artery in-stent restenosis.
Six-month results from the DEBELLUM trial (Drug-eluting balloon evaluation for lower limb multilevel treatment) have confirmed the efficacy of drug-eluting balloons (In.Pact Admiral and In.Pact Amphirion, Medtronic) to reduce restenosis following treatment for peripheral arterial disease vs. a conventional angioplasty balloon. Data have recently been published in the October issue of the Journal of Endovascular Therapy.
On 15 October, Lombard Medical announced it has received written feedback from the US Food and Drug Administration (FDA) on the pre-market approval application for Aorfix stent graft for the endovascular repair of abdominal aortic aneurysms.
The SUPERB pivotal clinical trial has shown positive clinical data for the Supera Peripheral Stent System (IDEV Technologies) in treating patients with obstructive superficial femoral artery disease. Kenneth Rosenfield, Section head for Vascular Medicine and Intervention at Massachusetts General Hospital and study co-principal investigator, presented the 12-month outcomes in the Late Breaking Trials session at the Vascular Interventional Advances (VIVA) 2012 (Las Vegas, USA, 9–12 October 2012).
Lawrence A Garcia, chief of Interventional Cardiology and Vascular Interventions at St Elizabeth’s Medical Center in Boston, USA, presented, at a Late-Breaking Clinical Trial session at VIVA (Las Vegas, USA, 9–12 October), final 12-month results from the DEFINITIVE LE study which demonstrated the long-term effectiveness of directional atherectomy with the SilverHawk and TurboHawk peripheral plaque excision systems (Covidien) as a frontline therapy for the treatment of peripheral arterial disease (PAD).
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.
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