Endologix has announced the US launch of its new Vela proximal endograft system, a clinical solution for endovascular repair in a broad range of aortic neck anatomies. A press release from the company says the Vela system is specifically designed for the treatment of proximal aortic neck anatomies during an endovascular aneurysm repair procedure using the Endologix AFX endovascular AAA System.
InspireMD has announced that its new CGuard carotid embolic protection system has been successfully implanted in recent procedures, including a patient treated during the 17(th) Annual Symposium on Interventional Cardiology & Angiology held in Hamburg, Germany on 1 February 2014.
Interventional News has learned that the UK CAVA trial, a four-way randomised controlled trial of long-term venous access devices for the delivery of chemotherapy (Ports versus tunnelled central lines versus peripherally inserted central catheters) has begun.
Boston Scientific has announced the US launch and first use of the OffRoad re-entry catheter system. The system provides a new option to treat chronic total occlusions in the femoropopliteal arteries.
Biotronik has announced the release of its Passeo-18 Lux drug-eluting balloon in all countries accepting the CE mark, following recent CE approval. The Passeo-18 Lux DRB catheter has shown clinical efficacy in the BIOLUX P-I study. Data collected at six- and 12-month intervals demonstrated that patients treated with Passeo-18 Lux were less likely to require treatment again.
Six-month results from the prospective, single-arm, multicentre, European ESPRIT I trial being presented at the 26th annual International Symposium on Endovascular Therapy (ISET, 18–22 January, Miami, USA) suggest that the Esprit drug-eluting bioresorbable vascular scaffold (Abbott Vascular) appears to be effective in treating iliac and femoral lesions.
The most recent results of the multicentre, non-randomised, single-arm prospective STROLL trial were presented at the 26th annual International Symposium on Endovascular Therapy (ISET, 18–22 January, Miami, USA). The trial is studying the safety and efficacy of the S.M.A.R.T. stent (Cordis) in patients with obstructive superficial femoral artery disease.
Treatment of femoropopliteal lesions with the low-dose Lutonix drug-eluting balloon reduces late lumen loss with safety comparable to that of control angioplasty, according to LEVANT I trial results published in the January 2014 issue of JACC: Cardiovascular Interventions.
Gore announced on 27 January 2014 that Himanshu Patel and David Williams, University of Michigan, USA, enrolled the first patient in the Gore TAG Thoracic Branch Endoprosthesis LSA Feasibility Study, a US-based, multicentre feasibility trial. The FDA approved the investigational device exemption (IDE) trial for the Gore TAG Thoracic Branch Endoprosthesis in the treatment of thoracic aortic aneurysms that require coverage of the left subclavian artery (LSA).
Veniti announced on 23 January 2014 that patients in the European Union (EU) were successfully treated for symptomatic venous outflow obstruction of the lower extremities with the Veniti Vici Venous Stent System. These procedures mark the first uses in patients of this novel venous stent from Veniti. More procedures using the Veniti Vici Venous Stent System are scheduled at various locations in the EU, including a live case demonstration at the Leipzig Interventional Course (LINC) on 28 January 2014.
AtheroMed has announced receiving US FDA approval to market the Phoenix Atherectomy System that allows physicians to continuously remove diseased material as it is debulked from patients with peripheral arterial disease, using a low profile atherectomy catheter.
The Ovation registry is evaluating the treatment of abdominal aortic aneurysms in the real-world setting of routine clinical practice. Including the Ovation pre-market clinical trial, over 700 patients have participated in a clinical study with either the Ovation or Ovation Prime stent graft system. The 30-day OVATION post-market study results were presented at the Leipzig Interventional Course (LINC) 2014 on 28 January 2014.
Data from the INNOVATION study presented at the Leipzig Interventional Course (LINC) in Germany continue to demonstrate that the Incraft endovascular aortic repair (EVAR) system from Cordis performs well in patients suffering from abdominal aortic aneurysms two years after treatment. The results were presented on 28 January 2014.
Medtronic has received US FDA approval for use of the Valiant Captivia Thoracic Stent Graft System in the treatment of type B aortic dissections.
Findings from the IN.PACT DEEP clinical trial showed that use of the IN.PACT Amphirion drug-eluting balloon from Medtronic did not result in a differential treatment effect for patients with below-the-knee critical limb ischaemia as compared to use of a standard percutaneous transluminal angioplasty balloon.
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