Avacen is to partner with Morulaa HealthTech of Chennai, India, to introduce its Avacen 100 class II medical device to the country. Initial focus will be to reduce the number of limb amputations resulting from diabetic foot ulcers.
Avinger has announced positive two-year clinical data from the pivotal VISION study of the company’s Lumivascular technology. Twenty-four-month follow-up results from 89 patients were presented by Patrick Muck, chief of Vascular Surgery at Good Samaritan Hospital in Cincinnati, USA, at New Cardiovascular Horizons (NCVH) in New Orleans, USA. This includes an additional 34 patients beyond the interim data set presented on January 25, 2017.
Iliac artery aneurysms—affecting up to one third of patients with complex aortic aneurysms—do not affect all-cause mortality or aneurysm-related mortality in endovascular repair of complex aortic aneurysms, according to a study presented at the 2017 Vascular Annual Meeting (VAM; 30 May–3 June, San Diego, USA).
Biotronik has announced that 12-month data from the BIOFLEX-I study have demonstrated the safety and efficacy of the company’s Pulsar-18 self-expanding stent for blocked superficial femoral artery treatment. The study results were presented during a late-breaking session at the 2017 Complex Cardiovascular Catheter Therapeutics Advanced Endovascular and Coronary Intervention Global Summit (C3; 29–30 June, Orlando, USA).
Cagent Vascular has announced the completion of enrolment in the first-in-human PRELUDE study. The purpose of this prospective, single-arm, multicentre feasibility study is to show the safety and efficacy of the company’s Serranator Alto device used in the superficial femoral artery (SFA) and/or popliteal artery.
Cook Medical is recalling the Zenith Alpha thoracic endovascular graft when used for the treatment of blunt traumatic aortic injury because thrombus may form inside the device after implantation. Cook Medical is also aware of reported cases where the graft became occluded when used to treat such injuries. The thrombosis or occlusion may lead to serious adverse health consequences, including death.
Bard Peripheral Vascular has announced it has received CE marking to market the Covera Plus vascular covered stent.
Fusion imaging can be used for infrarenal endovascular aneurysm repair (EVAR) following a short learning curve with the benefit of lower radiation dose and shorter procedure times, according to a presentation giving at the 2017 Vascular Annual Meeting (VAM; 31 May–3 June, San Diego, USA).
Endologix has announced positive interim results from the LEOPARD (Looking at EVAR outcomes by primary analysis of randomised data) clinical study. LEOPARD is the first and only head-to-head, prospective, multicentre, randomised clinical study comparing currently available endovascular abdominal aortic stent grafts. LEOPARD directly compares the Endologix AFX and AFX2 endografts to other commercially available bifurcated aortic endografts.
Endologix has announced 30-day results from the LUCY (Evaluation of Females who are Underrepresented Candidates for Abdominal Aortic Aneurysm Repair) study. The data showed that at least 28% more women became eligible for minimally-invasive endovascular aneurysm repair (EVAR) when using the company’s Ovation abdominal stent graft system.
QT Vascular has started enrolment in its US pivotal clinical study. The study will evaluate the company’s Chocolate Touch drug-coated balloon (DCB), for use in superficial femoral and popliteal arteries.
Essential Medical has announced that more than 1,000 Manta large bore vascular closure devices have been successfully deployed globally. To meet the growing demands of the large bore closure market, Essential Medical is also increasing their production capacity with a new facility located in Exton, USA.
At the 2017 Vascular Annual Meeting (VAM; 30 May–3 June, San Diego, USA), mid-term follow-up data from a pivotal trial (IBE 12-04) of the Excluder Iliac Branch Endoprosthesis (IBE, Gore) and the real-world GREAT Registry showed that the device is effective at treating common iliac artery and aortoiliac aneurysms, maintaining blood flow into the internal iliac artery, and avoiding complications associated with internal iliac artery sacrifice.
The US Food and Drug Administration (FDA) has approved an Investigational Device Exemption (IDE) supplemental application to modify the primary endpoint in Intact Vascular’s TOBA II BTK (Tack optimized balloon angioplasty II below the knee) clinical trial from 12 months to six months.
Laminate Medical has announced the success of the first four Spanish clinical cases using the VasQ device.
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