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for the Ranger DCB and<br />
74.0% for PTA at 12 months<br />
(p=0.0005).<br />
The Ranger DCB also<br />
demonstrated nearly 90%<br />
primary patency in the<br />
investigator-sponsored<br />
COMPARE trial – the first<br />
head-to-head prospective,<br />
randomized controlled trial<br />
to compare two different<br />
DCBs. In the trial, the Ranger<br />
DCB demonstrated a similar<br />
primary patency rate of<br />
88.4% to that of the 89.4%<br />
observed with IN.PACT<br />
Admiral Drug-Coated Balloon<br />
(Medtronic) by Kaplan-Meier<br />
estimate (p=0.81), with a<br />
significantly lower drug dose<br />
density (2 µg/mm2 paclitaxel<br />
versus 3.5 µg/mm2 paclitaxel,<br />
respectively).<br />
510(k) clearance<br />
to Abiomed’s<br />
Breethe OXY-1<br />
system<br />
Abiomed announced<br />
that the US FDA has<br />
granted a 510(k) clearance<br />
for an all-in-one, compact<br />
cardiopulmonary bypass<br />
system called the Abiomed<br />
Breethe OXY-1 System.<br />
The ECMO system<br />
provides cardiopulmonary<br />
bypass support for patients<br />
whose lungs can no longer<br />
provide sufficient end-organ<br />
oxygenation. The 510(k)<br />
clearance is to<br />
pump, oxygenate, and<br />
remove carbon dioxide<br />
from blood during<br />
cardiopulmonary bypass for<br />
up to six hours.<br />
The system can help<br />
provide oxygenation to<br />
patients suffering from<br />
cardiogenic shock or<br />
respiratory failures such<br />
as ARDS, H1N1, SARS, or<br />
COVID-19. When used with<br />
the Impella heart pump<br />
it can unload the heart<br />
and oxygenate the body, a<br />
combination therapy known<br />
as ECpella.<br />
The components of the<br />
system are designed to<br />
reduce the overall equipment<br />
footprint, support patient<br />
ambulation, and provide an<br />
intuitive interface for health<br />
care providers to set up and<br />
manage. The integrated<br />
pump lung unit is engineered<br />
with volute spiral technology<br />
for uniform blood flow with<br />
minimal stagnation and<br />
advanced gas exchange<br />
technology that allows for full<br />
therapy with reduced oxygen<br />
requirements.<br />
Philips launches<br />
Ultrasound 3300 system<br />
in India<br />
Royal Philips has<br />
launched the<br />
Ultrasound 3300,<br />
a new innovative<br />
ultrasound series tailored<br />
for obstetrics and<br />
gynaecology (OBGYN),<br />
general imaging and<br />
cardiovascular imaging<br />
procedures.<br />
The Ultrasound<br />
3300 series is a versatile<br />
system and delivers<br />
exceptional image quality<br />
across a variety of clinical<br />
applications such as<br />
OBGYN, cardiology and<br />
general imaging. The<br />
system is ergonomically<br />
designed to ensure<br />
high patient throughput<br />
and enhanced user and<br />
patient comfort.<br />
The Ultrasound 3300<br />
system delivers features<br />
including Automatic<br />
Follicle Counting on 2D<br />
probes, which reduces<br />
cost for customers and<br />
improves throughput in<br />
clinic set-ups.<br />
The affordable system<br />
also comes equipped<br />
with Nuchal Translucency<br />
(NT) Assist feature, which<br />
automatically measures<br />
the thickness of the<br />
nuchal translucency during<br />
first trimester scans. This<br />
feature also helps in<br />
streamlining the workflow<br />
while helping to increase<br />
the reliability of the<br />
measurement.<br />
The Ultrasound 3300<br />
offers the auto ejection<br />
fraction feature, increasing<br />
the diagnostic confidence<br />
for cardiologists. It also<br />
comes equipped with<br />
the largest-in-class 21.5-<br />
inch LED monitor which<br />
provides enhanced<br />
image resolution and<br />
folds down for easy<br />
transportation.<br />
The state-of-the-art<br />
system also consists of<br />
advanced applications<br />
like contrast imaging and<br />
needle enhancement<br />
features. The new<br />
generation algorithm<br />
of the machine reduces<br />
speckle noise while<br />
enabling physicians to<br />
get natural and smooth<br />
images, Phillips said.<br />
<strong>December</strong> <strong>2020</strong> / FUTURE MEDICINE / 73
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