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.
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.
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