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.
New independent data from Thomas Jefferson University in Philadelphia, USA, has demonstrated that the use of negative pressure therapy using Prevena incision management system may reduce the rate of major wound complications and associated costs following vascular groin surgery in high-risk patients. The results were presented at the 2017 Society for Vascular Surgery annual meeting (SVS; May 31–June 3, San Diego, USA).
Getinge has announced the opening of a new modern hybrid operating room (OR) in the Experience Center in Rastatt, Germany. The Hybrid OR will enable intraoperative 2D and 3D imaging during minimally invasive surgery.
The Society for Vascular Surgery (SVS) executive board has established a task force to explore developing a vascular certification program for inpatient and outpatient care settings.
Atherectomy for occlusive disease in the femoral-popliteal and tibial-peroneal segments for claudication in outpatient settings may result in outcomes worse than the natural history of the disease, according to data presented at the 2017 Vascular Annual Meeting (VAM; 30 May–3 June, San Diego, USA).
Philips has announced the relaunch of its Pioneer Plus catheter, “the first and only re-entry device with intravascular ultrasound (IVUS) capabilities and needle deployment designed to assist arterial vessel intervention,” according to a company press release.
Philips has completed the acquisition of Spectranetics. Spectranetics’ financial results will be consolidated as part of Philips’ Image-Guided Therapy business group as of August 9, 2017.
Results published in Diabetes Care demonstrate that the Podimetrics SmartMat detected as many as 97% of developing nontraumatic plantar foot ulcers on average five weeks before they presented clinically.
Type B aortic dissection (TBAD) patients exhibit poor adherence to best medical therapy, which may play a part in the high levels of aortic morbidity and mortality seen in this patient cohort, according to research presented by Colin Bicknell (London, UK) at the 2017 Critical Issues meeting (19–20 May, Nuremberg, Germany).
LimFlow announced on 1 August 2017 publication of positive results from the pilot study of the LimFlow Percutaneous Deep Vein Arterialization System (pDVA) in the July issue of the Journal of Endovascular Therapy. The paper is entitled “Midterm Outcomes from a Pilot Study of Percutaneous Deep Vein Arterialization for the Treatment of No-Option Critical Limb Ischemia.” The LimFlow System is a novel, purely percutaneous device for the treatment of end-stage critical limb ischaemia (CLI) when all other revascularisation efforts have been exhausted.
Positive two-year clinical data from Endologix’ Nellix EVAS FORWARD investigative device exemption trial have been presented at the Society of Vascular Surgery (SVS; 31 May–3 June) 2017 annual meeting. The trial prospectively enrolled patients with abdominal aortic aneurysms (AAA) who were treated with the Nellix endovascular aneurysm sealing system.
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