March 2019 digital v1

Robotic catheter
for lung biopsy
gets clearance
The US FDA cleared the
Ion endoluminal system
to enable minimally invasive
biopsy in the peripheral lung,
Intuitive Surgical said.
The Ion system uses
an ultra-thin articulating
robotic catheter that can
move 180 degrees
in all directions. The
outer diameter of the
catheter is 3.5 mm,
which physicians can
navigate through small
and tortuous airways to
reach nodules in any airway
segment within the lung.
The Ion system’s flexible
biopsy needle
can also pass
through very
tight bends
via Ion’s catheter
to collect tissue in
the peripheral lung.
The catheter’s 2mm
working channel can
also accommodate
other biopsy tools, such
as biopsy forceps or
cytology brushes, if
necessary.
The system’s fibre optic
shape sensor technology
provides the physician
with the precise location
and shape information of
the catheter throughout
the navigation and biopsy
process.
The Ion system easily
integrate into existing lung
nodule biopsy workflows,
as well as existing imaging
technology, including
fluoroscopy, radialendobronchial
ultrasound, and
cone-beam CT.
Bone loss
treatment device
gets approvals
NuVasive received 510(k)
clearance from the US FDA
as well as European CE mark
approval for its Precice Bone
Transport System for use in
segmental bone loss treatment
in the tibia and femur resulting
from trauma or infection.
The Precice Bone
Transport System includes
an implantable, magnetic
intramedullary nail with a dual
slot designed to support the
transport of an intercalary
bone segment to facilitate
healthy regeneration. Following
implantation, an external
remote controller is used
to precisely move the bone
segment up to 10 centimetres
based on the specific needs of
each patient.
It provides an all-internal
solution compared to
traditional external fixation
systems which require patients
to wear an external device for
an extended period of time,
with the potential for increased
pain and risk of infection.
Indications for the Precice
Bone Transport System include
treatment of acute bone
defects up to 10 centimeters.
The stainless-steel device
provides the strength and
stability needed to treat more
complex segmental defects
due to trauma or infection
including infected non-unions,
segmental defect and chronic
bone infections.
Neuromodulator
to treat bladder
wins CE mark
S
timRouter Neuromodulation
System developed by
Bioness has received CE Mark
Approval in Europe for the
treatment of overactive bladder
(OAB).
In the US, the StimRouter
currently has FDA approval for
the treatment of chronic pain
of a peripheral nerve origin as
US FDA clears DR 800 imaging system
Agfa NV has received FDA
510(k) clearance for its DR 800
multipurpose imaging system with
tomosynthesis.
Tomosynthesis is used to synthesize
tomographic slices from a single
tomographic sweep.
The DR 800 includes Agfa’s
tomosynthesis algorithms for iterative
reconstruction, which deliver images
with less noise and fewer artefacts.
These algorithms also enable faster
image reconstruction overcoming the
usual slow iterative reconstruction
process.
The DR 800 comes standard with
Dynamic MUSICA, for both static and
dynamic images. This image processing
software enhances noise suppression,
offers superb brightness control, reduces
veiling glare, and plays a significant role
in enabling potential dose reduction.
The MUSICA Digital TomoSynthesis
software powers the tomosynthesis
reconstruction, automatically
presenting images with
optimal contrast
and providing
consistent image
quality across the
individual slices and
images.
March 2019 / FUTURE MEDICINE / 71