It looks as though drug-eluting balloons (DEBs) already widely used in Europe are set to burst into the global market, as heart conditions become a more common problem, states a new report by healthcare experts GBI Research.
Minimally invasive elective repairs of abdominal aortic aneurysms, potential deadly bulges in arteries, reduces vessel rupture and short-term, AAA-related mortality, according to a Beth Israel Deaconess Medical Center study.
New results from the PARTNER Cohort B trial presented at the TCT congress have shown that transcatheter aortic valve implantation (TAVI) yielded lower mortality rates after three years compared with medical therapy in patients deemed to be ineligible for conventional aortic valve surgery.
October 24, 2012—The Cardiovascular Research Foundation (CRF) announced that results from the ETAP (Endovascular Treatment of Popliteal Artery–Balloon Angioplasty Versus Primary Stenting) trial were presented by lead investigator Thomas Zeller, MD, at the CRF’s TCT 2012: Transcatheter Cardiovascular Therapeutics conference in Miami, Florida. ETAP evaluated a nitinol stent versus balloon angioplasty alone in treating blockages of the popliteal artery.
Daniel Clair, chairman, Department of Vascular Surgery, The Cleveland Clinic Foundation, presented at the TCT congress twelve-month clinical endpoint data from the ORION trial, which demonstrated robust safety and effectiveness outcomes for the Epic Self-Expanding Nitinol Stent System (Boston Scientific) in patients with iliac artery disease.
A computerised checklist system designed to help physicians identify and use the best methods of preventing potentially venous thromboembolism (VTE) in hospitalised trauma patients dramatically reduced the number of these dangerous VTEs, according to researchers from the Johns Hopkins University School of Medicine, Baltimore, USA.
The European Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency has recommended the approval of the oral anticoagulant rivaroxaban for the treatment of pulmonary embolism and prevention of recurrent pulmonary embolism and deep vein thrombosis.
October 23, 2012—In the Journal of the American College of Cardiology: Cardiovascular Interventions, George Dangas, MD, et al published findings of a meta-analysis of randomized trials comparing open versus endovascular stent graft repair of abdominal aortic aneurysms (AAA) (2012;5:1071–1080). The study sought to evaluate short-, intermediate-, and longer-term outcomes, including both AAA-related and all-cause mortality.
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).
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