FM NOVEMBER 2018 ISSUE - digital edition

Zeiss laser tech to treat astigmatism
Carl Zeiss Meditec’s
expanding myopia
treatment for patients
with astigmatism received
premarket approval from the
USFDA.
ReLEx Smile utilises a highprecision
femtosecond laser
to create a lenticule inside the
cornea and access incision
in a single treatment step.
Incisions are made through
microscopic-photodisruptions
of tissue, created by ultrashort
pulses. VisuMax laser is the
first femtosecond laser to
receive FDA PMA approval for
the treatment of a refractive
indication in addition to 510k
clearances for LASIK flap,
keratoplasty, and ICR.
The technology behind
Smile was recently featured
in the scientific background
on the Nobel Prize in Physics
2018. Dr. Gérard Mourou and
Dr. Donna Strickland were
awarded the Nobel Prize
for his method to generate
high-intensity ultrashort
optical pulses. Their invention
of so-called chirped pulse
amplification is essential to
generate the ultrashort laser
pulses of the Zeiss VisuMax
femtosecond laser system,
according to the company.
Carl Zeiss Meditec AG
is the Medical Technology
Business Group of Zeiss.
level(s). These patients should
be skeletally mature and have
completed six months of
non-operative treatment, the
company said.
Fujifilm launches
endoscopes to
detect GI cancers
Fujifilm India Private Limited
launched a range of novel
image-enhanced endoscopy
products for the detection of
gastro cancers.
Eluxeo 7000 Series
endoscopes have Blue Light
Imaging (BLI)/Linked Colour
Imaging (LCI) technology to
aid early detection of all types
of stomach cancers.
Stomach cancer is the
second-most common cancer
among men and third-most
among females in Asia. The
symptoms and sign of the
stomach cancer are often
reported late when the
disease is already in advanced
stages, and the 5-year survival
rate is less than 30 percent
in developed countries
and around 20 percent in
developing countries.
The company said the
Eluxeo 7000 is targeted for
biopsy and early alarm by
helping obtain high-resolution
images to detect cancers at a
very early stage.
Drug-eluting
stent approved
for PAD
Boston Scientific
Corporation’s drugeluting
vascular stent system,
specifically developed for the
treatment of peripheral
artery disease (PAD), has
been approved by the
US FDA.
The Eluvia stent
utilizes a drug-polymer
combination to provide
sustained release of
the drug paclitaxel for a
one-year timeframe. It is
designed to prevent tissue
regrowth that might otherwise
block the stented artery.
The approval was based
on findings from the IMPERIAL
trial, the first superficial
femoral artery head-tohead
drug-eluting stent trial
evaluating the safety and
efficacy of Eluvia vs Zilver PTX
in 465 patients.
The results of the trial
showed that patients
treated with the Eluvia stent
experienced a significantly
greater 12-month primary
patency of 88.5 percent,
compared to 79.5 percent in
patients treated with Zilver
PTX.
The Eluvia stent system
is built on the Innova
Stent System platform,
a self-expanding nitinol
stent that has been designed
for use in the superficial
femoral and proximal popliteal
arteries, the main arteries that
supply blood to the legs.
Self-fitting OTC
hearing aid
gets nod
The USFDA has cleared
the Bose Hearing Aid,
a self-fitting hearing aid
for individuals 18 years or
older with perceived mild to
moderate hearing impairment.
This hearing aid enables
users to fit, programme and
control the hearing aid on
their own, without assistance
from a health care provider.
The Bose Hearing Aid
is a user-fitted wireless air
conduction hearing aid. Air
conduction hearing aids
work by capturing sound
vibrations through one or
more microphones. The
signal is processed, amplified,
and played back through an
earphone placed in the ear
canal.
Patients can adjust the
hearing aid through a mobile
application on their phone.
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