Bolton Medical has announced the first implant of the Treo abdominal stent graft system in the Treo Registry, a post-market surveillance clinical investigation that aims to assess long term real-world data of the device in a global, prospective, multicentre and observational study.
Gore has announced the first patient implant of the TAG conformable thoracic stent graft with Active Control system after the receipt of CE mark last month. The first implant was performed by Giovanni Torsello and Martin Austermann at St Franziskus Hospital, Munster, Germany.
Med Alliance has announced the on-schedule completion of patient enrolment in the first-in-man (FIM) study of Selution, the company’s sirolimus-coated balloon. Fifty patients have been enrolled between 26 October 2016 and 23 May 2017 across four German centres: Franziskus Krankenhaus, Berlin; Evangelisches Krankenhaus Hubertus, Berlin; Vivantes Klinikum Neukölln, Berlin; and Universitäts-Herzzentrum, Bad Krozingen.
The first patient has been enrolled in Medtronic’s IN.PACT arteriovenous (AV) access drug-coated balloon (DCB) study for use in patients with end-stage renal disease.
LimFlow SA has announced enrolment of the first patient in the US feasibility study of the LimFlow percutaneous deep vein arterialisation (pDVA) system, a novel, purely percutaneous device for the treatment of end-stage critical limb ischaemia (CLI) when all other revascularisation efforts have been exhausted. The first patient was treated on 5 July at Metro Health–University of Michigan Health, Wyoming, USA, by Jihad A Mustapha.
The management of type B aortic dissections represents a significant challenge for the vascular community. Despite the great advances obtained since the development of endovascular treatment, questions still remain on how to best treat complicated and uncomplicated dissections, and when. Trying to seek consensus on how to address the different scenarios, Cook Medical held its second Global Dissection Forum, a gathering of experts who discussed the most pressing topics surrounding dissection-specific devices, the aspects involved in the decision of whether to intervene or not, the time of intervention, and techniques for false lumen thrombosis.
Getinge has announced the full US market release of the Pulsar-18 stent from Biotronik. Pulsar-18 is the only available self-expanding stent for blocked superficial femoral arteries with a 4F delivery system. Getinge currently distributes Biotronik’s portfolio of products to treat peripheral artery disease (PAD) in the USA. The addition of the Pulsar-18 stent to Getinge’s portfolio extends the company’s commitment to deliver innovative solutions to meet customer and patient needs.
Gore has received Shonin approval from the Japanese Ministry of Health, Labour and Welfare to market the Excluder iliac branch endoprosthesis (IBE), and is currently in discussion regarding reimbursement for this region.
As the US Congress debates funding Medicaid and the uninsured, a new vascular study finds that hospitals with a high ratio of those two patient groups are less able to save patients who develop serious surgical complications.
Intact Vascular’s TOBA II BTK (Tack optimized balloon angioplasty II below the knee) clinical trial has commenced enrolment in Europe, with the first patient treated by Marianne Brodmann and Peter Reif at Medical University Graz, Austria.
Laminate Medical Technologies, an Israeli biomedical start-up developing VasQ, an implanted blood vessel external support device for patients requiring arteriovenous fistula as vascular access for haemodialysis, announced on 1 August 2017 that it has received investigational device exemption (IDE) approval from the FDA. IDE approval allows Laminate to evaluate the safety and efficacy of VasQ in clinical trials in the United States, with the goal of obtaining FDA marketing approval.
One-year data from Cardiovascular System’s all-comers LIBERTY 360 clinical study have demonstrated sustained benefits following endovascular intervention in critical limb ischaemia patients.
A new sub-analysis from Cardiovascular System’s LIBERTY 360 study supports the use of the company’s Diamondback 360 peripheral orbital atherectomy system (OAS) during endovascular intervention for Rutherford Class 2–6 patients.
LimFlow, developer of minimally-invasive technology for the treatment of end-stage critical limb ischaemia (CLI), has announced the expansion of the company’s senior management team. Sophie Humbert has been appointed to the role of chief operating officer (COO) and Thomas Engels, III, has assumed the role of vice president of clinical affairs. The Paris, France-based company also announced the opening of its first US office in Silicon Valley, USA.
On 30 June 2017, Lombard Medical notified the UK Medicines and Health products Regulatory Agency (MHRA) about problems with the Altura stent graft device. The letter stated that all lot numbers in the catalogues 01-AA-24-090, 01-AA-27-090 and 01-AA-30-090 were being recalled.
Cookies Sociales
Son esos botones que permiten compartir el contenido del sitio web en sus redes sociales (Facebook, Twitter y Linkedin, previo tu consentimiento y login) a través de sistemas totalmente gestionados por dichas redes sociales, así como los recursos (pej. videos) y material que se encuentra en nuestra web, y que de igual manera se presta y gestiona completamente por un tercero.
Si no acepta estas cookies, no podrá compartir nuestro contenido a través de los botones, y en su caso, no podrás visualizar el contenido de terceros que hayamos incrustado en el sitio.
No las utilizamos