FDA clears "first silver impregnated needle-free access device"
This article was originally published in Clinica
Executive Summary
B Braun Medical's Ultrasite Ag Luer access device has received 510(k) clearance from the US FDA. The company claims it is the industry's first silver-impregnated antibacterial Luer access device designed to reduce potential catheter-related bloodstream infections, such as MRSA. The clearance comes at a time when there is increased focus on the prevention of these infections – it is expected to be a major topic at the upcoming US Association for Vascular Access (AVA) meeting, following major changes to the Medicare programme that will stop payments for certain conditions not present at hospital admission (see Clinica No 1322, p 9). The Bethlehem, Pennsylvania firm added that the needle-free system, which will be available later this year, also reduces accidental needlesticks.
You may also be interested in...
What are the hottest innovations from Israel?
Israel is well-known as a medtech hot-spot, with a focus on academic research and strong government support helping the country punch well above its weight when it comes to innovative devices.
EuroPCR: St Jude and Philips talk up rival intravascular imaging techs
St Jude Medical had a heavy focus on its intravascular imaging offering at this year’s EuroPCR meeting, presenting data supporting its optical coherence tomography (OCT) technology. OCT provides intravascular images to help assess culprit lesions, which can improve stent selection and deployment, according to St Jude.
EuroPCR: Medtronic's drug-coated balloon keeps rising
A big topic at this year’s EuroPCR, held in Paris on 19-22 May, was drug-coated balloons (DCBs). One of the leaders in the field, Medtronic, presented positive data from two studies of its IN.PACT Admiral balloon, which could support an expanded indication for the device.