HyperMed Imaging is now selling its new HyperView imaging system to customers in the USA.
The European Commission has approved, under the EU Merger Regulation, the acquisition of Bard by BD. The decision is conditional on the divestment of BD’s core needle biopsy devices business, and tissue marker product that is currently under development.
Endologix has appointed John Onopchenko as the company’s chief operating officer, effective as of 30 October, 2017. Onopchenko will be responsible for managing Endologix’s manufacturing, supply chain, and quality organisations.
Surmodics has announced enrolment of the first patient in TRANSCEND, the pivotal clinical trial for the SurVeil drug-coated balloon (DCB). The randomised trial will evaluate the SurVeil DCB for treatment for peripheral artery disease (PAD) in the upper leg compared to a commercially available DCB treatment.
Symic Bio has announced results from the phase I/II SHIELD trial evaluating SB-030, a locally administered therapeutic, in patients with peripheral vascular disease undergoing angioplasty. In this first-in-human, prospective, randomised, single-blind controlled study of 67 patients, SB-030 demonstrated a positive safety profile, with no clinically meaningful difference observed in adverse events between treatment and control groups. In addition, treatment with SB-030 demonstrated potential for improvements as compared to control across measurements of clinical efficacy in late lumen loss, target lesion revascularisation and primary patency rate.
Avinger has announced initiation of INSIGHT, a prospective, global, single arm, multicentre study to evaluate the safety and effectiveness of the Pantheris Lumivascular Atherectomy System for treating in-stent restenosis (ISR) in lower extremity arteries.
Gore has announced the first patient enrolment in its post-market European registry for the Gore TAG Conformable Thoracic Stent Graft with Active Control System, following its recent European launch in July 2017. The thoracic endovascular aortic repair (TEVAR) device is the first to feature a new delivery system that provides the physician with controlled, staged deployment.
Mercator MedSystems has announced completion of enrolment in the company’s LIMBO-ATX (Lower-limb adventitial infusion of dexamethasone via Bullfrog to reduce occurrence of restenosis after atherectomy-based revascularization) clinical trial. The LIMBO-ATX trial was designed to use Mercator’s proprietary Bullfrog micro-infusion catheter to test a new treatment strategy to potentially improve blood flow and decrease repeat revascularisation procedures in below-the-knee critical limb ischaemia.
An innovative, investigational treatment approach is showing the potential to address an important, unresolved problem encountered by patients with kidney failure on dialysis. At the recent annual meeting of the American Society of Nephrology (ASN), Vascular Therapies presented preliminary results relating to analysis of the first 18 (open-label) patients from its US phase III study. The study is testing the effect of the sirolimus-eluting collagen implant on arteriovenous fistula outcomes. The results suggest this investigational treatment approach may reduce a patient’s dependence on the extended use of catheters.
Percutaneous closure of large-bore arterial access sites using the Perclose ProGlide suture-mediated closure device (Abbott Vascular) is associated with significantly lower rates of blood transfusions, infections, mortality and length of hospital stay, compared with surgical cutdown in a real-world setting, according to new data presented at the Vascular Interventional Advances 2017 conference (VIVA; 11–14 September, Las Vegas, USA).
At the European Society for Vascular Surgery (ESVS) meeting (19–22 September, Lyon, France), Vascular News spoke to Florian Dick (University of Bern, Bern, Switzerland) about the new Global Vascular Guidelines for chronic limb-threatening ischaemia, which were presented to delegates as part of the scientific sessions. Dick told Vascular News about the main message behind the guidelines, and how they will form a framework around which the evidence base can grow. The guidelines are expected to be published online in the first quarter of 2018.
Philips has announced the results of an independent two-year study on clinicians’ use of Azurion, the company’s image-guided therapy platform, at St. Antonius Hospital. The study finds that use of Azurion by clinicians in the hospital resulted in significant time savings and higher employee satisfaction.
Cagent Vascular has announced the issuance of its CE marking for the Serranator percutaneous transluminal angioplasty (PTA) serration balloon catheter. Cagent Vascular has also achieved its ISO 13485 Certification. The Serranator is one of a family of peripheral artery disease (PAD) technologies which incorporates proprietary serration technology to an angioplasty balloon.
A 53-year-old woman with a complex aortic malfunction causing a bulging blood vessel attended University Hospital Mainz (Mainz, Germany), having been rejected by several other hospitals due to the risky nature of her required surgery. Bernhard Dorweiler— head of the Department of Vascular Surgery at the hospital—utilised an emerging technology to assist in the careful planning of the surgery.
Positive single-centre 24-month results from Intact Vascular’s TOBA (Tack optimised balloon angioplasty) clinical study were presented at the 2017 VEITHsymposium 2017 (14–18 November, New York City, USA) by Christian Wissgott (Westküstenklinikum Heide, Heide, Germany).
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