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.
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.
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