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.
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.
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.
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.
Nitiloop has received FDA clearance for its new Nova Cross Extreme and Nova Cross BTK. According to the company, these dedicated microcatheters are joining the Nova Cross product family “combining innovative low profile microcatheter technology with uniquely designed nitinol scaffold providing enhanced guidewire and microcatheter support for safer and more effective lesion crossing”.
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.
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.
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.
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).
Vascular Flow Technologies (VFT) has announced the successful conclusion of a strategic intellectual property out-licencing agreement with Biovic Sdn bhd.
Bayer and its cooperation partner Janssen Research & Development have announced two publications of further data from the Phase III COMPASS study in The Lancet, one in patients with peripheral artery disease (PAD) and the other in patients with coronary artery disease (CAD).
InspireMD has announced it has signed Diverse Devices as its exclusive distributor for Australia and New Zealand, and has signed Do Gia Production and Trading JSC as its exclusive distributor in Vietnam. The company’s product line includes the Cguard embolic prevention system (EPS).
CryoLife, Inc, a leading medical device and tissue processing company focused on cardiac and vascular surgery, announced today that it has completed its previously announced acquisition of Jotec AG, a German-based, privately-held developer of technologically differentiated endovascular stent grafts, and cardiac and vascular surgical grafts, focused on aortic repair.
Following a fenestrated endovascular aneurysm repair (FEVAR), the infrarenal aortic neck often continues to dilate. At the 2017 VEITHsymposium, Benjamin Starnes (University of Washington, Seattle, USA) suggested that such dilation is harmful when observed in standard EVAR practised outside instructions for use (IFU) or in association with a hostile neck. However, Starnes said that aortic neck dilation is harmless when observed with FEVAR, and that “less device oversizing may be acceptable given long seal zone lengths”.
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