October 30, 2014—RenovoRx announced that it has received US Food and Drug Administration 510(k) clearance of the RenovoCath RC120 catheter, which is designed for the isolation of blood flow and delivery of fluids, including diagnostic material and therapeutic agents, into selected sites in the peripheral vascular system utilizing a dual-balloon occlusion design.
October 27, 2014—Essential Medical, Inc. announced that it has received European CE Mark approval for its X-Seal vascular closure device. X-Seal closes femoral arterial punctures made during cardiac catheterization procedures such as angiograms, angioplasty, and stenting. The device is designed to provide catheterization lab professionals with superior closure and improved hemostasis, stated the company.
October 22, 2014—Gynesonics, Inc. announced that the US Food and Drug Administration (FDA) has approved an investigational device exemption for the pivotal SONATA trial of sonography-guided transcervical ablation of uterine fibroids to evaluate the company’s VizAblate system. The VizAblate system is designed to provide a transcervical, incision-free, outpatient option to invasive surgical procedures, such as hysterectomy, for the relief of symptomatic uterine fibroids.
November 13, 2014—Covidien announced that the 6-month results of the VeClose pivotal study demonstrated the safety and effectiveness of the VenaSeal closure system in patients with chronic venous insufficiency having symptomatic reflux in the great saphenous vein. The results were presented at ACP 2014, the American College of Phlebology’s annual congress, in Phoenix, Arizona.
November 12, 2014—The Society for Vascular Surgery (SVS) and Society of Interventional Radiology (SIR), on behalf of the Inferior Vena Cava (IVC) Filter Study Group Foundation, announced the planned 2015 commencement of the multicenter PRESERVE (Predicting the Safety and Effectiveness of Inferior Vena Cava Filters) study with the participation of seven IVC filter manufacturers. SVS and SIR collaboratively formed the IVC Filter Study Group Foundation, a 501(c)(3) not-for-profit entity that sponsors and oversees PRESERVE.
November 4, 2014—Cardinal Health announced that its MynxGrip vascular closure device received US Food and Drug Administration approval for use to close femoral veins. The MynxGrip device is now indicated for use to seal 5-F, 6-F, and 7-F femoral arterial and femoral venous access sites. The MynxGrip device is intended to reduce times to hemostasis and ambulation, thereby potentially shortening postprocedure recovery times, stated the company.
The International Carotid Stenting Study (ICSS) randomised trial has reported the long-term outcomes after stenting versus endarterectomy for treatment of symptomatic carotid stenosis in The Lancet, online ahead of print, on 14 October.
There is a compelling case for the medical community, including the device industry, to develop specific devices that are appropriate for paediatric patients. Paediatric interventional radiologists often have to “make do” and be creative in order to treat children whilst using devices that are designed for and tested on adults only. The need for appropriate devices for the paediatric population ranges from the common and simple, such as long-term feeding tubes and vascular access devices, to the expensive and biomechanically complex, such as bioabsorbable stent-grafts, say opinion leaders in the field.
The 12-month results of the study, presented at CIRSE 2014, demonstrated that new microwave technology can achieve a substantial rate of complete necrosis of liver metastases, even in a short-term treatment with few major complication
Terumo Europe has announced the creation of an Interventional Oncology division that will be active as of 1 April 2015. The specialisation of the interventional oncology team will allow Terumo Europe to be more focused, and thus more efficient in this fast growing market, a press release from the company states
Ablative Solutions has announced that the first patient in the Peregrine Study has been treated with company’s the investigational Peregrine system, which delivers agents directly to the sympathetic-nerve-laden peri-adventitial area of the renal artery to perform chemical neurolysis. Wojtek Wojakowski is the principal investigator of the study, and the patient has now been discharged from the hospital
Hansen has announced the completion of the first robot-assisted uterine fibroid embolization in the USA. Sandeep Rao, interventional radiologist, performed the procedure at Sierra Medical Center in El Paso, Texas, using the Magellan Robotic System
The company has announced that commercial cases were performed at The University Hospital, Leuven, Belgium, where Geert Maleux successfully treated two patients with the EOS device
Medtronic announced on 10 October 2014 the executive team who will lead the combined organisation following the close of its proposed acquisition of Covidien. The new company will be comprised of four major business groups and four geographic regions led by a new Executive Committee. Omar Ishrak will remain as chairman and chief executive officer of the new company, Medtronic plc.
Novate Medical has announced that Souheil Saddekni, professor of Vascular and Interventional Radiology at the University of Alabama, Birmingham, USA, has enrolled the first patient in the SENTRY IDE study.
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